EN Sonderdruck Curasan Knochenersatz mit Cerasorb 106379008

© Deutscher Ärzteverlag | OUP | 2017; 6 (3)

1

O U POrthopädische und Unfallchirurgische Praxis

www.online-oup.de

Vereinigung Süddeutscher Orthopäden und Unfallchirurgen e.V. www.vsou.de

Alfred Gruber

Bone substitute with Cerasorb in orthopedic surgery,

traumatology and hand surgeryKnochenersatz mit Cerasorb in der orthopädischen Chirurgie,

Unfallchirurgie und Handchirurgie

6. Jahrgang/Seite 164–1716. Jahrgang20173

REPRINT

Reproduction – even in part –, duplication, microcopy, storage in electronic databases and translation only with the permission of

Deutscher Ärzteverlag GmbH, 50832 Köln, Postfach 40 02 65, Germany

Orthopädische und Unfallchirurgische Praxiswww.online-oup.de

Vereinigung Süddeutscher Orthopäden und Unfallchirurgen e.V. www.vsou.de

Alfred Gruber

Knochenersatz mit Cerasorb in der orthopädischen Chirurgie,

Unfallchirurgie und Handchirurgie

ang/Seite 164–1716. Jahrg6. Jahrgangang20117

REPRINT

Reproduction – even in part –, duplication, microcopy, storage in electronic databases and translation only with the permission of

Deutscher Ärzteverlag GmbH, 50832 Köln, Postfach 40 02 65, Germany

http://www.online-oup.de/

http://www.vsou.de/

■ © Deutscher Ärzteverlag | OUP | 2017; 6 (3)

2

REF. No. Size Content

9000 020 205 1000 – 2000 μm 2.0 cc 5

9000 020 501 1000 – 2000 μm 5.0 cc 1

CERASORB ® Plus Granules


9000 301 001 1000 – 2000 μm 1.0 cc 1

9000 301 005 1000 – 2000 μm 1.0 cc 5

9000 302 005 1000 – 2000 μm 2.0 cc 5

9000 305 001 1000 – 2000 μm 5.0 cc 1

9000 310 001 1000 – 2000 μm 10.0 cc 1

9000 405 001 2000 – 3000 μm 5.0 cc 1

9000 410 001 2000 – 3000 μm 10.0 cc 1

9000 430 001 2000 – 3000 μm 10.0 cc 3

9000 510 001 3000 – 5000 μm 10.0 cc 1

9000 530 001 3000 – 5000 μm 10.0 cc 3

9000 630 001 5000 – 8000 μm 10.0 cc 3

CERASORB ® M Granules


9001 304 061 3 2.0 cc 1

9001 304 071 3 3.0 cc 1

CERASORB ®

blueblue

purple

Legend

CERASORB®.

Product Overview


9000 020 205 1000 – 2000 μm 2.0 cc 5

9000 020 501 1000 – 2000 μm 5.0 cc 1

CERASORB ® Plus Granules


9000 301 001 1000 – 2000 μm 1.0 cc 1

9000 301 005 1000 – 2000 μm 1.0 cc 5

9000 302 005 1000 – 2000 μm 2.0 cc 5

9000 305 001 1000 – 2000 μm 5.0 cc 1

9000 310 001 1000 – 2000 μm 10.0 cc 1

9000 405 001 2000 – 3000 μm 5.0 cc 1

9000 410 001 2000 – 3000 μm 10.0 cc 1

9000 430 001 2000 – 3000 μm 10.0 cc 3

9000 510 001 3000 – 5000 μm 10.0 cc 1

9000 530 001 3000 – 5000 μm 10.0 cc 3

9000 630 001 5000 – 8000 μm 10.0 cc 3

CERASORB ® M Granules


9001 304 061 3 2.0 cc 1

9001 304 071 3 3.0 cc 1

CERASORB ®

blueblue

purple

Legend

CERASORB®.

Product Overview


3


9000 060 254 2.5 cc 1

9000 060 504 5.0 cc 1

9000 061 004 10.0 cc 1

CERASORB ®


9000 050 504 5.0 cc 1

9000 051 004 10.0 cc 1

CERASORB ®


9008 204 301 pc 1

CERASORB ® Cube


9008 204 601 pc 1

9008 204 701 pc 1

9008 204 801 pc 1

9008 204 901 pc 1

9008 205 102 pcs 2

9008 205 202 pcs 2

9008 205 302 pcs 2

CERASORB ®


9008 204 201 pc 1

9008 204 401 pc 1

CERASORB ®


9008 105 201 ø 8,5 mm pc 1

9008 105 101 ø 9,5 mm pc 1

9008 105 001 ø 10,5 mm pc 1

CERASORB ®

www.curasan.com

-

-

-

-

-

-

N.C., USA.

-

Source: curasan AG


9000 060 254 2.5 cc 1

9000 060 504 5.0 cc 1

9000 061 004 10.0 cc 1

CERASORB ®


9000 050 504 5.0 cc 1

9000 051 004 10.0 cc 1

CERASORB®


9008 204 301 pc 1

CERASORB® Cube


9008 204 601 pc 1

9008 204 701 pc 1

9008 204 801 pc 1

9008 204 901 pc 1

9008 205 102 pcs 2

9008 205 202 pcs 2

9008 205 302 pcs 2

CERASORB®


9008 204 201 pc 1

9008 204 401 pc 1

CERASORB®


9008 105 201 ø 8,5 mm pc 1

9008 105 101 ø 9,5 mm pc 1

9008 105 001 ø 10,5 mm pc 1

CERASORB®

www.curasan.com

-

-

-

-

-

-

N.C., USA.

-

Source: curasan AG

http://www.curasan.com/


4

Abstract: Between 1997 and 2013 a total number of 106 cases with the indications tumor (most frequent

diagnosis: enchondroma), rheumatism, and trauma were in-cluded in a prospective monocentre study design. In most cases hand surgery was performed. All patients were treated with Cerasorb, a synthetic resorbable bone regeneration ma-terial. Autologous spongious bone was administered addi-tionally in 8 surgical operations, in 59 cases platelet rich plas-ma (PRP) was used. In the long term resorption of the ce-ramic material and simultaneous formation of vital auto-logous bone took place regularly. There were no clinical ir-regularities, allergic reactions or potential complications documented due to the material. No major differences be-tween the 3 indication groups regarding resorption of Cera-sorb and bone healing could be observed. The additional use of autologous spongious bone or PRP showed no further improvement of the bone healing and regeneration process.

Keywords: hand surgery, bone regeneration, bone substitute, long-term study, Cerasorb, β-TCP, Beta-Tricalciumphosphate, rheumatoid arthritis (RA), bone cyst, fracture, bone tumor, osteotomy

Citation

Gruber A: Bone substitute with Cerasorb in orthopedic surgery, trau-

matology and hand surgery. A long-term observation over 10 years.

OUP 2017; 3: 164–171 DOI 10.3238/oup.2017.0164–0171

Alfred Gruber1

Bone substitute with Cerasorb in orthopedic surgery, traumatology and hand surgeryA long-term observation over 10 years

Knochenersatz mit Cerasorb in der orthopädischen Chirurgie, Unfallchirurgie und Handchirurgie

Langzeitbeobachtung über 10 Jahre

Zusammenfassung: Im Zeitraum von 1997–2013 wurden 106 Fälle mit den Indikationen Tumor (häufigste Diagnose: Enchondrom), Rheuma und Trauma in eine prospektive mo-nozentrische Studie eingeschlossen. In den meisten Fällen handelte es sich um handchirurgische Eingriffe. Alle Patien-ten wurden mit dem synthetischen, resorbierbaren Knochen-regenerationsmaterial Cerasorb behandelt. Bei 8 Eingriffen kam zusätzlich autologe Spongiosa, in 59 Fällen Plättchenrei-ches Plasma (PRP) zum Einsatz. Im Langzeitverlauf zeigten sich regelmäßig eine komplette Integration und eine Resorp-tion des keramischen Materials zeitgleich zur Bildung körper-eigenen Knochens. Es wurden keine klinischen Auffälligkei-ten, Allergien oder potenziell materialbedingte Komplikatio-nen dokumentiert. Soweit beurteilbar, finden sich zwischen den 3 Indikationsgruppen keine wesentlichen Unterschiede bezüglich der Resorption von Cerasorb und eine gleicherma-ßen gute knöcherne Heilung. Der Zusatz von PRP oder auto-loger Spongiosa zu Cerasorb zeigte keine weitere Verbes-serung des Heilungs- und Regenerationsprozesses.

Schlüsselwörter: Handchirurgie, Knochenregeneration, Knochen-ersatzmaterial, Langzeitstudie, Cerasorb, β-TCP, Beta-Tri -calciumphosphat, Rheumatoide Arthritis (RA), Knochenzyste, Fraktur, Knochentumor, Umstellungskorrektur-Osteotomie

Zitierweise

Gruber A: Knochenersatz mit Cerasorb in der orthopädischen

Chirurgie, Unfallchirurgie und Handchirurgie. Langzeitbeobachtung

über 10 Jahre.

OUP 2017; 3: 164–171 DOI 10.3238/oup.2017.0164–0171

1 RTZ Nürnberg

Introduction

In many surgical fields there is a need for bone substitute material [KEM] and

bone regeneration material [KAM]. The autologous bone transplant is still domi-nating in orthopaedics and traumatol-ogy, when taking the absolute quantities

into account. In the majority of cases autologous bone material is derived from the iliac crest as spongiosa chip or as corticospongious span. The generally

WISSENSCHAFT / RESEARCH Übersichtsarbeit / Review


4

Abstract: Between 1997 and 2013 a total number of 106 cases with the indications tumor (most frequent

diagnosis: enchondroma), rheumatism, and trauma were in-cluded in a prospective monocentre study design. In most cases hand surgery was performed. All patients were treated with Cerasorb, a synthetic resorbable bone regeneration ma-terial. Autologous spongious bone was administered addi-tionally in 8 surgical operations, in 59 cases platelet rich plas-ma (PRP) was used. In the long term resorption of the ce-ramic material and simultaneous formation of vital auto-logous bone took place regularly. There were no clinical ir-regularities, allergic reactions or potential complications documented due to the material. No major differences be-tween the 3 indication groups regarding resorption of Cera-sorb and bone healing could be observed. The additional use of autologous spongious bone or PRP showed no further improvement of the bone healing and regeneration process.

Keywords: hand surgery, bone regeneration, bone substitute, long-term study, Cerasorb, β-TCP, Beta-Tricalciumphosphate, rheumatoid arthritis (RA), bone cyst, fracture, bone tumor, osteotomy

Citation

Gruber A: Bone substitute with Cerasorb in orthopedic surgery, trau-

matology and hand surgery. A long-term observation over 10 years.

OUP 2017; 3: 164–171 DOI 10.3238/oup.2017.0164–0171

Alfred Gruber1

Bone substitute with Cerasorb in orthopedic surgery, traumatology and hand surgeryA long-term observation over 10 years

Knochenersatz mit Cerasorb in der orthopädischen Chirurgie, Unfallchirurgie und Handchirurgie

Langzeitbeobachtung über 10 Jahre

Zusammenfassung: Im Zeitraum von 1997–2013 wurden 106 Fälle mit den Indikationen Tumor (häufigste Diagnose: Enchondrom), Rheuma und Trauma in eine prospektive mo-nozentrische Studie eingeschlossen. In den meisten Fällen handelte es sich um handchirurgische Eingriffe. Alle Patien-ten wurden mit dem synthetischen, resorbierbaren Knochen-regenerationsmaterial Cerasorb behandelt. Bei 8 Eingriffen kam zusätzlich autologe Spongiosa, in 59 Fällen Plättchenrei-ches Plasma (PRP) zum Einsatz. Im Langzeitverlauf zeigten sich regelmäßig eine komplette Integration und eine Resorp-tion des keramischen Materials zeitgleich zur Bildung körper-eigenen Knochens. Es wurden keine klinischen Auffälligkei-ten, Allergien oder potenziell materialbedingte Komplikatio-nen dokumentiert. Soweit beurteilbar, finden sich zwischen den 3 Indikationsgruppen keine wesentlichen Unterschiede bezüglich der Resorption von Cerasorb und eine gleicherma-ßen gute knöcherne Heilung. Der Zusatz von PRP oder auto-loger Spongiosa zu Cerasorb zeigte keine weitere Verbes-serung des Heilungs- und Regenerationsprozesses.

Schlüsselwörter: Handchirurgie, Knochenregeneration, Knochen-ersatzmaterial, Langzeitstudie, Cerasorb, β-TCP, Beta-Tri -calciumphosphat, Rheumatoide Arthritis (RA), Knochenzyste, Fraktur, Knochentumor, Umstellungskorrektur-Osteotomie

Zitierweise

Gruber A: Knochenersatz mit Cerasorb in der orthopädischen

Chirurgie, Unfallchirurgie und Handchirurgie. Langzeitbeobachtung

über 10 Jahre.

OUP 2017; 3: 164–171 DOI 10.3238/oup.2017.0164–0171

1 RTZ Nürnberg

Introduction

In many surgical fields there is a need forbone substitute material [KEM] and

bone regeneration material [KAM]. The autologous bone transplant is still domi-nating in orthopaedics and traumatol-ogy, when taking the absolute quantities

into account. In the majority of cases autologous bone material is derived from the iliac crest as spongiosa chip or as corticospongious span. The generally

WISSENSCHAFT / RESEARCH Übersichtsarbeit / Review


5

used term „Gold Standard“ in connec-tion with autologous bone transplants, however, has to be viewed critically and was apparently developed against the background of lacking alternatives, as its use is associated with a variety of dis-advantages, among others, an extended period of surgical intervention, pain at the point of extraction and additional scars, possible damage of nerves and vessels, impaired healing and infec-tions. Besides that, the availability of autologous bone transplants is limited [1, 2, 3].

Potential immunological risks and residual risks of infections cannot be re-liably excluded in connection with the use of allogeneic bones. They are there-fore referred to as „the surgeon´s second option“ [4]. Allogeneic material is as-sociated with the possibility of transfer-ring pathogenic germs and a possible re-jection by the immune system in con-nection with a residual risk which can-not be ultimately excluded [5]. Alloge-neic materials will not be available in fu-ture in an unlimited scope [6].

Xenogenic bone substitute material is primarily of bovine origin and is ap-plied as highly tempered protein-free hydroxylapatite (HA) or as chemically treated HA containing residual protein. Both HA types resorb hardly at all and can disturb bone remodelling when used as pure defect fillers. Besides that, there is the risk of transferring proteins [5] in connection with the use of chemi-cally treated bovine bones.

Due to their composition and the manufacturing process, synthetic ma-terials, such as β-Tricalcium phosphate (β-TCP) are free of a potential risk of transmitting pathogenic germs. They are available in an unlimited scope. Pre-vious human studies in orthopaedics and accident surgery document that β-TCP can be successfully implanted without complications in the case of various defects and defect volumes [14, 15, 16, 19, 24], thus representing a genu-ine alternative to bone transplants in the case of certain indications – whereby compliance with certain aspects is sig-nificant with regard to ensuring a suc-cessful outcome. It is necessary to ensure that any direct contact between β-TCP and soft tissue is avoided, to ensure that connective tissue does not grow into the defect as it might even impact or even prevent the formation of new bones [4].

In the case of optimum contact with the bone at the lower border of the defect bone, the β-TCP material connects with-in the sense of osseointegration [8], fol-lowed by a continuous resorption with simultaneous new formation of auto-logous bone, so-called „gradual substitu-tion“. In addition, allergic reactions are to date unknown with this material [9].

β-TCP possesses no primary osteoin-ductivity or osteogenic potency. Its low

Chart 1 Diagnoses of the surgical interven-

tions performed (N = 103). Absolute values

are specified.

Chart 2 Osteosynthesis measures. Absolute

values are specified.

Chart 3 Cerasorb granule sizes and quan-

tities used

Diagnosis

Enchondrome (4 with fracture)

Arthrodesis

Cyst

TEP

Fracture

Comminuted fracture

Corrective osteosynthesis

Corrective osteotomy

TEP-replacement

Osteoid osteoma

Injury from horse bite

Juvenile fibroma, fibula

N

30

16

18

11

8

7

4

3

2

2

1

1

Measure

Disks/miniature disks

Screws

K-wires

Clamps

Cerclages

KN-Cement

External fixation

N

17

14

12

4

4

1

1

Cerasorb

Granule sizes

500– 1000 μm

1000– 2000 μm

2000– 3000 μm

In 7 cases various sizes were mixed

Rods : 3

Wedges : 3

Foam: 1

Granule quantities in cc

0.1

0.2

0.25

0.3

0.35

0.4

0.5

0.7

0.75

0.8

0.9

1.0

1.25

1.3

1.4

1.5

1.9

2.0

3.0

3.5

5.0

13.0

k.A.

62 interventions

40 interventions

2 interventions

Case No.: 37, 76, 79

Case No. : 91, 94, 106

Case No.: 105

12

7

9

3

1

4

23

3

1

5

2

8

1

3

1

7

1

1

1

1

1

1

1

Median: 0,5 cc

Gruber: Bone substitute with Cerasorb in orthopedic surgery, traumatology and hand surgeryKnochenersatz mit Cerasorb in der orthopädischen Chirurgie, Unfallchirurgie und Handchirurgie


5

used term „Gold Standard“ in connec-tion with autologous bone transplants, however, has to be viewed critically and was apparently developed against the background of lacking alternatives, as its use is associated with a variety of dis-advantages, among others, an extended period of surgical intervention, pain at the point of extraction and additional scars, possible damage of nerves and vessels, impaired healing and infec-tions. Besides that, the availability of autologous bone transplants is limited [1, 2, 3].

Potential immunological risks and residual risks of infections cannot be re-liably excluded in connection with the use of allogeneic bones. They are there-fore referred to as „the surgeon´s second option“ [4]. Allogeneic material is as-sociated with the possibility of transfer-ring pathogenic germs and a possible re-jection by the immune system in con-nection with a residual risk which can-not be ultimately excluded [5]. Alloge-neic materials will not be available in fu-ture in an unlimited scope [6].

Xenogenic bone substitute material is primarily of bovine origin and is ap-plied as highly tempered protein-free hydroxylapatite (HA) or as chemically treated HA containing residual protein. Both HA types resorb hardly at all and can disturb bone remodelling when used as pure defect fillers. Besides that, there is the risk of transferring proteins [5] in connection with the use of chemi-cally treated bovine bones.

Due to their composition and the manufacturing process, synthetic ma-terials, such as β-Tricalcium phosphate (β-TCP) are free of a potential risk of transmitting pathogenic germs. They are available in an unlimited scope. Pre-vious human studies in orthopaedics and accident surgery document that β-TCP can be successfully implanted without complications in the case of various defects and defect volumes [14, 15, 16, 19, 24], thus representing a genu-ine alternative to bone transplants in the case of certain indications – wherebycompliance with certain aspects is sig-nificant with regard to ensuring a suc-cessful outcome. It is necessary to ensure that any direct contact between β-TCP and soft tissue is avoided, to ensure that connective tissue does not grow into the defect as it might even impact or even prevent the formation of new bones [4].

In the case of optimum contact with the bone at the lower border of the defect bone, the β-TCP material connects with-in the sense of osseointegration [8], fol-lowed by a continuous resorption with simultaneous new formation of auto-logous bone, so-called „gradual substitu-tion“. In addition, allergic reactions are to date unknown with this material [9].

β-TCP possesses no primary osteoin-ductivity or osteogenic potency. Its low

Chart 1 Diagnoses of the surgical interven-

tions performed (N = 103). Absolute values

are specified.

Chart 2 Osteosynthesis measures. Absolute

values are specified.

Chart 3 Cerasorb granule sizes and quan-

tities used

Diagnosis

Enchondrome (4 with fracture)

Arthrodesis

Cyst

TEP

Fracture

Comminuted fracture

Corrective osteosynthesis

Corrective osteotomy

TEP-replacement

Osteoid osteoma

Injury from horse bite

Juvenile fibroma, fibula

N

30

16

18

11

8

7

4

3

2

2

1

1

Measure

Disks/miniature disks

Screws

K-wires

Clamps

Cerclages

KN-Cement

External fixation

N

17

14

12

4

4

1

1

Cerasorb

Granule sizes

500– 1000 μm

1000– 2000 μm

2000– 3000 μm

In 7 cases various sizes were mixed

Rods : 3

Wedges : 3

Foam: 1

Granule quantities in cc

0.1

0.2

0.25

0.3

0.35

0.4

0.5

0.7

0.75

0.8

0.9

1.0

1.25

1.3

1.4

1.5

1.9

2.0

3.0

3.5

5.0

13.0

k.A.

62 interventions

40 interventions

2 interventions

Case No.: 37, 76, 79

Case No. : 91, 94, 106

Case No.: 105

12

7

9

3

1

4

23

3

1

5

2

8

1

3

1

7

1

1

1

1

1

1

1

Median: 0,5 cc



6

mechanical resilience is a known ma-terial-related weakness. The progress in ceramic technology raises expectations that the stress tolerance will be im-proved. Aims are going in the direction of combining the synthetic calcium-phosphate matrix with structure pro-teins, e.g. collagen [10].

Xenogeneic bone substitution ma-terials – in the majority of cases originat-ing from bovine bones – resorb at an ex-tremely low rate and even after over 10 years hardly show any loss of substance in the tissue. Such remodelled and/or inte-grated materials always remain in the bone bed as foreign substances. They serve as persisting defect filler that, how-ever, suppresses free remodelling of the bone at the location of the lesion and thus prevents the bone structure from adapting to biomechanical stress [11].

As none of the afore-mentioned foreign materials fulfils the requirements of an ideal bone regeneration material, greater efforts were undertaken over the past years to develop synthetic materials, whereby special interest was focused on β-TCP [12, 13].

Numerous investigations in oral and maxillofacial surgery, as well as in dental medicine, document the fact that β-TCP was successfully applied to regenerate the unstressed bone. The scientific documentation on clinical studies and case reports is particularly detailed in the case of the synthetic β-TCP ad modum Cerasorb (curasan AG) [14, 15, 16, 17]. Meanwhile long-term observa-tions over 10 years are now available documenting the use of this material in

Chart 4 Overall evaluation of all 3 indications: Trauma, rheumatism, tumour (n = 103, absolute values) Kx = Control examination, T = Day, M =

Median

Figure 2 Indication Tumour. The number of patients evaluated in the appropriate period under

review is stated. The category of clinical diagnostics is stated (1+ to 3+, negative values were not

assigned). Period under review in days as specified. M = Median

Figure 1 General evaluation. Specified is the number of patients evaluated in the appropriate

period under review. The category of the clinical finding is stated in each individual case (1+ to

3+, negative values were not assigned). Examination period in days as specified. M = Median

Time

Evaluation

+ 3

+ 2

+ 1

0

k.A.

Post-OP

Day 1

48

41

11

-

3

K1 Day 7

T 3 – 254 M = 7

49

37

9

-

7

K2 Day 14

T 11 – 99 M = 21

55

28

15

-

5

K3 6 Weeks

T 29–1762 M = 60

48

28

17

1

7

K4 6 Months

T 61–1645 M = 190

45

15

13

-

29

K5 12 Months

T 88–2755 M = 385

25

14

13

-

49

Completion

T 183–2676 M = 656

11

9

6

-

73



6

mechanical resilience is a known ma-terial-related weakness. The progress in ceramic technology raises expectations that the stress tolerance will be im-proved. Aims are going in the direction of combining the synthetic calcium-phosphate matrix with structure pro-teins, e.g. collagen [10].

Xenogeneic bone substitution ma-terials – in the majority of cases originat-ing from bovine bones – resorb at an ex-tremely low rate and even after over 10years hardly show any loss of substance inthe tissue. Such remodelled and/or inte-grated materials always remain in thebone bed as foreign substances. They serve as persisting defect filler that, how-ever, suppresses free remodelling of thebone at the location of the lesion and thus prevents the bone structure fromadapting to biomechanical stress [11].

As none of the afore-mentioned foreign materials fulfils the requirementsof an ideal bone regeneration material,greater efforts were undertaken over thepast years to develop synthetic materials,whereby special interest was focused onβ-TCP [12, 13].

Numerous investigations in oral and maxillofacial surgery, as well as in dental medicine, document the fact that β-TCPwas successfully applied to regenerate the unstressed bone. The scientific documentation on clinical studies and case reports is particularly detailed in the case of the synthetic β-TCP ad modum Cerasorb (curasan AG) [14, 15, 16, 17]. Meanwhile long-term observa-tions over 10 years are now available documenting the use of this material in

Chart 4 Overall evaluation of all 3 indications: Trauma, rheumatism, tumour (n = 103, absolute values) Kx = Control examination, T = Day, M =

Median

Figure 2 Indication Tumour. The number of patients evaluated in the appropriate period under



Figure 1 General evaluation. Specified is the number of patients evaluated in the appropriate

period under review. The category of the clinical finding is stated in each individual case (1+ to

3+, negative values were not assigned). Examination period in days as specified. M = Median

Time

Evaluation

+ 3

+ 2

+ 1

0

k.A.

Post-OP

Day 1

48

41

11

-

3

K1Day 7

T 3 – 254M = 7

49

37

9

-

7

K2Day 14

T 11 – 99M = 21

55

28

15

-

5

K36 Weeks

T 29–1762M = 60

48

28

17

1

7

K4 6 Months

T 61–1645M = 190

45

15

13

-

29

K5 12 Months

T 88–2755M = 385

25

14

13

-

49

Completion

T 183–2676M = 656

11

9

6

-

73

Gruber:Bone substitute with Cerasorb in orthopedic surgery, traumatology and hand surgeryKnochenersatz mit Cerasorb in der orthopädischen Chirurgie, Unfallchirurgie und Handchirurgie


7

dental surgery [18]. In comparison with ora-surgical indications, the use of β-TCP in orthopaedics and accident sur-gery has been rather hesitant to date. The results of osseous healing after the use of β-TCP in the case of defects in hol-low bones are, however, also highly promising. As early as in 1999 Gruber re-ported of convincing results in several case histories in connection with the use of β-TCP in bone tumours, arthrodesis and bone fills in fractures [19].

This prospective clinical trial now shows the use of β-TCP (Cerasorb and Cerasorb M) in 103 cases from the thera-peutic fields of orthopaedic accident surgery, bone tumour surgery and in the case of inflammatory-rheumatic joint diseases in which an autologous or allo-genic bone transplantation was not per-formed as therapy of choice and the bone was substituted or remodelled with β-TCP.

Patients/Material and Methods

In an open, prospective, monocentric clinical trial the clinical application of the synthetic bone regeneration materi-al Cerasorb with regard to application, handling, resorption behaviour and safety under routine conditions was examined and documented. Cerasorb (curasan AG) is a purely synthetically manufactured ceramic made of β-Trical-cium phosphate (β-TCP). The porous material is available as granules in vari-ous grain sizes and with various degrees of porosity. For special applications moulded parts of various geometries as well as a collagen ceramic composite (Cerasorb Foam) are available.

The cases should be monitored ac-cording to a given protocol with clinical and radiological examinations and fol-low-ups at defined schedules and docu-mented on prepared standardised docu-mentation sheets. After documenting the patient’s past medical history and the initial diagnosis as well as intraoper-ative findings, follow-up examinations were carried at 7 specified control points: 1st day post-OP, K1 = 7 days, K2 = 14 days, K3 = 6 weeks, K4 = 6 months, K5 = 12 months post-OP and within the scope of a final examination. The de-fined criteria were clinical and radiologi-cal findings as well as a general clinical

evaluation with a 7-point scale ranging from 3+ via 0 to 3–.

The clinical trial took place from 15 October 1997 (inclusion of first patient) until 5 March 2013 (last examination, last patient). The inclusion criteria were documented in the order of sequence of their presentation.

Results

Patients and treatment

In total 106 interventions took place among 98 patients, whereby in the case of 6 patients these encompassed multiple

treatments. Three patients did not re-ceive Cerasorb, but were consistently car-ried forward as „controls“. The evalu-ation therefore took place for 103 inter-ventions and as group evaluation for the 3 indications tumour (52 interventions), rheumatism (28 interventions) and trau-ma (23 interventions). 50 women and 44 men aged 11.7 to 74.5 years of age were treated (mean value 43.7 years of age). For the individual indications an average patient age of 40.3 in the case of tu-mours, 56.6 in the case of rheumatism and 34.9 years of age in the case of trau-ma was determined. In the case of diag-noses the enchondrome dominated, being diagnosed in 30 cases. Arthrodesis

Figure 3 Indication Rheumatism. The number of patients evaluated in the appropriate period

under review is stated. The category of clinical diagnostics is stated (1+ to 3+, negative values

were not assigned). Period under review in days as specified. M = Median

Figure 4 Indication Trauma. The number of patients evaluated in the appropriate period under





7

dental surgery [18]. In comparison with ora-surgical indications, the use of β-TCP in orthopaedics and accident sur-gery has been rather hesitant to date. The results of osseous healing after the use of β-TCP in the case of defects in hol-low bones are, however, also highlypromising. As early as in 1999 Gruber re-ported of convincing results in severalcase histories in connection with the useof β-TCP in bone tumours, arthrodesis and bone fills in fractures [19].

This prospective clinical trial nowshows the use of β-TCP (Cerasorb andCerasorb M) in 103 cases from the thera-peutic fields of orthopaedic accidentsurgery, bone tumour surgery and in thecase of inflammatory-rheumatic jointdiseases in which an autologous or allo-genic bone transplantation was not per-formed as therapy of choice and the bone was substituted or remodelledwith β-TCP.

Patients/Material and Methods

In an open, prospective, monocentric clinical trial the clinical application of the synthetic bone regeneration materi-al Cerasorb with regard to application,handling, resorption behaviour andsafety under routine conditions was examined and documented. Cerasorb (curasan AG) is a purely syntheticallymanufactured ceramic made of β-Trical-cium phosphate (β-TCP). The porousmaterial is available as granules in vari-ous grain sizes and with various degrees of porosity. For special applicationsmoulded parts of various geometries aswell as a collagen ceramic composite(Cerasorb Foam) are available.

The cases should be monitored ac-cording to a given protocol with clinicaland radiological examinations and fol-low-ups at defined schedules and docu-mented on prepared standardised docu-mentation sheets. After documentingthe patient’s past medical history and the initial diagnosis as well as intraoper-ative findings, follow-up examinations were carried at 7 specified controlpoints: 1st day post-OP, K1 = 7 days, K2 =14 days, K3 = 6 weeks, K4 = 6 months, K5= 12 months post-OP and within thescope of a final examination. The de-fined criteria were clinical and radiologi-cal findings as well as a general clinical

evaluation with a 7-point scale ranging from 3+ via 0 to 3–.

The clinical trial took place from 15 October 1997 (inclusion of first patient) until 5 March 2013 (last examination, last patient). The inclusion criteria were documented in the order of sequence of their presentation.

Results

Patients and treatment

In total 106 interventions took placeamong 98 patients, whereby in the caseof 6 patients these encompassed multiple

treatments. Three patients did not re-ceive Cerasorb, but were consistently car-ried forward as „controls“. The evalu-ation therefore took place for 103 inter-ventions and as group evaluation for the3 indications tumour (52 interventions),rheumatism (28 interventions) and trau-ma (23 interventions). 50 women and 44men aged 11.7 to 74.5 years of age weretreated (mean value 43.7 years of age).For the individual indications an averagepatient age of 40.3 in the case of tu-mours, 56.6 in the case of rheumatismand 34.9 years of age in the case of trau-ma was determined. In the case of diag-noses the enchondrome dominated,being diagnosed in 30 cases. Arthrodesis

Figure 3 Indication Rheumatism. The number of patients evaluated in the appropriate period

under review is stated. The category of clinical diagnostics is stated (1+ to 3+, negative values

were not assigned). Period under review in days as specified. M = Median

Figure 4 Indication Trauma. The number of patients evaluated in the appropriate period under





8

(16 times) and cysts (18 times) were identified frequently. Conventional os-teosynthesis measures were applied, most frequently disks or miniature disks and screws were implanted (Tab. 2). The Cerasorb granule sizes and vol-umes are shown in Chart 3. In the case of 8 interventions autologous spongio-

sa were applied, after being mixed with Cerasorb. Platelet rich plasma (PRP) was additionally used in 59 cases, in the median 0.34 ml.

Postoperative procedure

The ceramic bone substitute material Cerasorb was implanted in a bland os -seous approach. In practically all cases a complete dissolution of the bone sub-stitute material and/or a complete the body’s own bone material. No clinical irregularities, allergies or potentially material-related complications were documented.

The post-operative procedure was initially evaluated on the basis of a 7-point scale using the stipulated examination schedules (Tab. 4). It crystallised that it was not always pos -sible to comply with the schedules for follow-ups. That led to a substantial variance with partial overlapping of the individual periods. For instance, the first follow-up had a range of 3–254 days, and the second follow-up a range of 11–99 days. A reliable analysis of the procedure was thus not possible. For that reason the individual follow-ups were realigned and re-evaluated based on the actual date of the examination. (Fig. 1 to Fig. 4).

When analysing all indications over the whole procedure it became evident that the majority of cases were assigned to category 3+. Category 2+ was the second most frequent category, followed by category 1+ in a reduced scope. The cases of category 2+ de-clined in the course of the procedure in favour of category 3+. The number of patients who were subsequently exam-ined dropped drastically with increas-ing periods between the follow-ups (Fig. 1).

Indication tumour

In all 52 patients of this group Cerasorb Granules were used, in 39 cases PRP was added, and in one case autologous Spongiosa. No post-operative compli-cations were observed. The ceramic material had almost completely dis-solved in all cases and substituted by autologous bone material. No de-formation or pseudoarthritis was iden -tified, but solely regular anatomical bone structures. Over the complete examination period it was possible to assign the majority of cases to category 3+. The second most frequent category was 2+, followed by category 1+. The ratio between the individual categories remained relatively constant over the whole period (Fig. 2).

Indication rheumatism

27 of the 28 patients with osseous de-fects as a result of their rheumatic dis-ease underwent surgery with the use of Cerasorb Granules, in one intervention a Cerasorb rod was used on which up to the last observation date (day 324) radiological ceramic material was vis-ible. In 9 cases autologous spongiosa was added, and in further 8 cases PRP. A favourable bone healing process was shown in all patients. No post-oper-ative complications were observed. New bones developed without de-formation or pseudarthritis. After one year the ceramic material had been sub-stituted in all cases by newly developed autologous bones and the previous de-fects had been well filled with osseous structures. Throughout the complete period of examination most of the cases were assigned to category 3+. The

Figure 5a Preoperative X-ray of 27 Septem-

ber 2000: 32-year old patient with a large en-

chodrome at the central joint of the small

finger on the left hand with extension over

2/3 of the proximal shaft, whereby the tu-

mour had extended and ballooned the shaft

extensively and at the basis of the central

joint only a very thin cortical border was

given.

Figure 5b Postoperative X-ray of

28.09.2000: Excavation of the enchodrome

cyst and filling with Cerasorb 1000–2000 μm

mixed with blood and PRP. The X-ray showed

a well-filled bone defect with clearly visible

granules.

Figure 5c Post-op X-ray of 19 February

2002: Completely healed tumour with nor-

mal bone structure and spongiosa structure.

No granules visible. The bone has also nar-

rowed in terms of its form. A completely nor-

mal and restored bone form within the sense

of remodelling is shown here, too.



8

(16 times) and cysts (18 times) wereidentified frequently. Conventional os-teosynthesis measures were applied, most frequently disks or miniature disks and screws were implanted (Tab.2). The Cerasorb granule sizes and vol-umes are shown in Chart 3. In the case of 8 interventions autologous spongio-

sa were applied, after being mixed with Cerasorb. Platelet rich plasma (PRP) was additionally used in 59 cases, in the median 0.34 ml.

Postoperative procedure

The ceramic bone substitute materialCerasorb was implanted in a bland os -seous approach. In practically all cases a complete dissolution of the bone sub-stitute material and/or a complete the body’s own bone material. No clinical irregularities, allergies or potentially material-related complications were documented.

The post-operative procedure was initially evaluated on the basis of a7-point scale using the stipulatedexamination schedules (Tab. 4). It crystallised that it was not always pos -sible to comply with the schedules forfollow-ups. That led to a substantial variance with partial overlapping of the individual periods. For instance, the first follow-up had a range of 3–254days, and the second follow-up a range of 11–99 days. A reliable analysis of the procedure was thus not possible. Forthat reason the individual follow-upswere realigned and re-evaluated based on the actual date of the examination. (Fig. 1 to Fig. 4).

When analysing all indications over the whole procedure it became evident that the majority of cases wereassigned to category 3+. Category 2+ was the second most frequent category, followed by category 1+ in a reducedscope. The cases of category 2+ de-clined in the course of the procedure in favour of category 3+. The number of patients who were subsequently exam-ined dropped drastically with increas-ing periods between the follow-ups (Fig. 1).

Indication tumour

In all 52 patients of this group Cerasorb Granules were used, in 39 cases PRP wasadded, and in one case autologous Spongiosa. No post-operative compli-cations were observed. The ceramic material had almost completely dis-solved in all cases and substituted by autologous bone material. No de-formation or pseudoarthritis was iden -tified, but solely regular anatomical bone structures. Over the completeexamination period it was possible to assign the majority of cases to category 3+. The second most frequent category was 2+, followed by category 1+. The ratio between the individual categories remained relatively constant over thewhole period (Fig. 2).

Indication rheumatism

27 of the 28 patients with osseous de-fects as a result of their rheumatic dis-ease underwent surgery with the use of Cerasorb Granules, in one intervention a Cerasorb rod was used on which up tothe last observation date (day 324) radiological ceramic material was vis-ible. In 9 cases autologous spongiosa was added, and in further 8 cases PRP. A favourable bone healing process was shown in all patients. No post-oper-ative complications were observed. New bones developed without de-formation or pseudarthritis. After one year the ceramic material had been sub-stituted in all cases by newly developed autologous bones and the previous de-fects had been well filled with osseous structures. Throughout the completeperiod of examination most of the cases were assigned to category 3+. The

Figure 5a Preoperative X-ray of 27 Septem-

ber 2000: 32-year old patient with a large en-

chodrome at the central joint of the small

finger on the left hand with extension over

2/3 of the proximal shaft, whereby the tu-

mour had extended and ballooned the shaft

extensively and at the basis of the central

joint only a very thin cortical border was

given.

Figure 5b Postoperative X-ray of

28.09.2000: Excavation of the enchodrome

cyst and filling with Cerasorb 1000–2000 μm

mixed with blood and PRP. The X-ray showed

a well-filled bone defect with clearly visible

granules.

Figure 5c Post-op X-ray of 19 February

2002: Completely healed tumour with nor-

mal bone structure and spongiosa structure.

No granules visible. The bone has also nar-

rowed in terms of its form. A completely nor-

mal and restored bone form within the sense

of remodelling is shown here, too.



9

second most frequent category was 2+ and only a few cases were assigned to category 1+. The number of cases in category 2+ declined over the overall procedure in favour of 3+ (Fig. 3).

Indication trauma

In 18 of the 23 patients Cerasorb Gran-ules were used, in 3 cases a Cerasorb wedge, in 2 further cases a Cerasorb rod. PRP was added seven times. In this indication group, too, no post-oper-ative complications were identified, and the granules had almost com-pletely resorbed after one year. The de-fect had thus been optimally regener-ated by newly developed bone materi-al. There ware no cases of deformation or pseudarthritis. Over the complete period a predominance of category 2+ cases was identified. In some investi-gation periods there were, however, an equal number of 3+ cases (42 days and 211 days). At the end of the examin-ation period there was a balanced ratio between all three categories (Fig. 4).

There were no substantial differ-ences between the 3 indication groups with regard to resorption of the ce-ramic bone substitute material and an even positive osseous healing process. The additional administration of PRP and/or autologous spongiosa did not additionally improve the good healing and regeneration process. In none of the patients treated were undesired reactions detected and which might re-sult from the use of Cerasorb. This speaks in favour of an optimal bio-compatibility of β-TCP Cerasorb in hand surgery.

In summary, it can be derived that Cerasorb® is optimally suitable for bone regeneration in hand surgery for all indications investigated here and can be used without complications.

Discussion

Reports on long-term results following surgery in traumatology and ortho-paedics are highly seldom. The clinical trial presented here is, according to the author’s knowledge, the first clinical trial reporting on a 10-year observation period with regard to the use of resorb-ably ceramic bone regeneration materi-

al (KAM). Harel et al. [18], however, re-cently published there experience in connection with the use of β-TCP Cera-sorb in dental surgery: In the retrospec-tive 10-year comparative clinical trial the implantation of dental implants in extraction alveoli augmented with Ce-rasorb proved to be on a par with im-plantation in natural bones. These long-term observations are extremely valuable, as they provide users and pa-tients with additional reliability on benefits and long-term compatibility of the materials used – and in particular with regard to resorbable KAM docu-ment the aspired complete osseous re-generation. In the cases treated here contact between on β-TCP and the sur-rounding soft tissue did not play any role. In comparison with dental im-plantation surgery in which soft tissue can grow into the extraction alveoli, dispersed β-TCP particles in the soft tis-sue surrounding the bones were also dissolved in our cases under review. We did not identify any calcification, cap-sular calcification or formation of ex-ophytes.

After healing completely without development of scars, the osseous tis-sue has an excellent property. The top priority in regenerating bone defects is thus to demand „restitutio ad inte-grum“. The prerequisite for the aspired bone remodelling is to achieve a simul-taneous resorption of the remodelling

material with the autologous regener-ation of bones at the same time main-taining stability [20].

The radiological data provided in this clinical trial clearly document that this can be achieved with the synthetic β-TCP used in this case. Similar results were achieved by Scheer et al. (2009) who used β-TCP in corrective osteomy

Figure 6a 21-year old patient with a com-

minuted fracture of the proximal phalanx of

the left ring finger with dislocation. Pre-op

X-ray of 2 November 1999: Multi-fragmented

fracture of the proximal phalanx of the ring

finger at the centre of the shaft with dorsal

tilting and fracture zones extending to the

base of the proximal phalanx. Open reposi-

tion and stabilisation with miniature reposi-

tion Synthes disk, as well as traction-screw

osteosynthesis and Cerasorb implantation

(1000–2000 μm) on 9 November 1999.

Figure 6b Post-op X-rays of 10 December

1999: First Cerasorbe is implanted in the ex-

cavated bone cavity in order to stabilise the

hollow. Then the other fragments are posi-

tioned. After this reconstruction the minia-

ture reposition disk manufactured by Synthes

is positioned. An additional ulnar com-

minuted tray positioned with the tension

screw.

Figure 6c Post-op X-ray of 16 May 2000: The

X-ray 7 months post-op shows a completely

healed fracture of the proximal phalanx with

horizontal disk. The bone is completely re-

modelled. No residual Cerasorb granules are

shown. With the dissolution of the granules

autologous spongiosa was simultaneously in-

tegrated; complete remodelling.



9

second most frequent category was 2+and only a few cases were assigned to category 1+. The number of cases in category 2+ declined over the overall procedure in favour of 3+ (Fig. 3).

Indication trauma

In 18 of the 23 patients Cerasorb Gran-ules were used, in 3 cases a Cerasorbwedge, in 2 further cases a Cerasorb rod. PRP was added seven times. In this indication group, too, no post-oper-ative complications were identified, and the granules had almost com-pletely resorbed after one year. The de-fect had thus been optimally regener-ated by newly developed bone materi-al. There ware no cases of deformation or pseudarthritis. Over the complete period a predominance of category 2+cases was identified. In some investi-gation periods there were, however, an equal number of 3+ cases (42 days and211 days). At the end of the examin-ation period there was a balanced ratiobetween all three categories (Fig. 4).

There were no substantial differ-ences between the 3 indication groups with regard to resorption of the ce-ramic bone substitute material and an even positive osseous healing process. The additional administration of PRP and/or autologous spongiosa did notadditionally improve the good healing and regeneration process. In none of the patients treated were undesiredreactions detected and which might re-sult from the use of Cerasorb. This speaks in favour of an optimal bio-compatibility of β-TCP Cerasorb in hand surgery.

In summary, it can be derived that Cerasorb® is optimally suitable for bone regeneration in hand surgery forall indications investigated here and can be used without complications.

Discussion

Reports on long-term results followingsurgery in traumatology and ortho-paedics are highly seldom. The clinical trial presented here is, according to the author’s knowledge, the first clinical trial reporting on a 10-year observation period with regard to the use of resorb-ably ceramic bone regeneration materi-

al (KAM). Harel et al. [18], however, re-cently published there experience in connection with the use of β-TCP Cera-sorb in dental surgery: In the retrospec-tive 10-year comparative clinical trial the implantation of dental implants in extraction alveoli augmented with Ce-rasorb proved to be on a par with im-plantation in natural bones. These long-term observations are extremelyvaluable, as they provide users and pa-tients with additional reliability on benefits and long-term compatibility of the materials used – and in particular with regard to resorbable KAM docu-ment the aspired complete osseous re-generation. In the cases treated here contact between on β-TCP and the sur-rounding soft tissue did not play any role. In comparison with dental im-plantation surgery in which soft tissue can grow into the extraction alveoli, dispersed β-TCP particles in the soft tis-sue surrounding the bones were also dissolved in our cases under review. We did not identify any calcification, cap-sular calcification or formation of ex-ophytes.

After healing completely without development of scars, the osseous tis-sue has an excellent property. The top priority in regenerating bone defects is thus to demand „restitutio ad inte-grum“. The prerequisite for the aspired bone remodelling is to achieve a simul-taneous resorption of the remodelling

material with the autologous regener-ation of bones at the same time main-taining stability [20].

The radiological data provided in this clinical trial clearly document that this can be achieved with the synthetic β-TCP used in this case. Similar results were achieved by Scheer et al. (2009) who used β-TCP in corrective osteomy

Figure 6a 21-year old patient with a com-

minuted fracture of the proximal phalanx of

the left ring finger with dislocation. Pre-op

X-ray of 2 November 1999: Multi-fragmented

fracture of the proximal phalanx of the ring

finger at the centre of the shaft with dorsal

tilting and fracture zones extending to the

base of the proximal phalanx. Open reposi-

tion and stabilisation with miniature reposi-

tion Synthes disk, as well as traction-screw

osteosynthesis and Cerasorb implantation

(1000–2000 μm) on 9 November 1999.

Figure 6b Post-op X-rays of 10 December

1999: First Cerasorbe is implanted in the ex-

cavated bone cavity in order to stabilise the

hollow. Then the other fragments are posi-

tioned. After this reconstruction the minia-

ture reposition disk manufactured by Synthes

is positioned. An additional ulnar com-

minuted tray positioned with the tension

screw.

Figure 6c Post-op X-ray of 16 May 2000: The

X-ray 7 months post-op shows a completely

healed fracture of the proximal phalanx with

horizontal disk. The bone is completely re-

modelled. No residual Cerasorb granules are

shown. With the dissolution of the granules

autologous spongiosa was simultaneously in-

tegrated; complete remodelling.



10

of the radius. The authors saw β-TCP as an alternative to the use of autologous bone material taken from the iliac crest [21]. In accordance with the data pro-vided a complete resorption of the β-TCP used with simultaneous regener-ation of bones was noticed within the observation period of 9 months in a further clinical trial conducted with calcaneus fractures [22]. Jakubietz and employees saw no advantage of a β-TCP treatment with intraarticular fractures of the distal radius in comparison with the internal fixing alone, however re-ported of an unproblematic appli-cation and resorption of the material [23]. Maus and team reported of over 30 patients with a variety of ortho-paedic indications treated with β-TCP Cerasorb. Post-treatment observations were conducted over a period of up to 34 months (on average 9 months). The application of the material was unprob-lematic. No patient suffered from any signs of local or systemic inflam-mation. Osseous consolidation was identified in all defects, thus proving that the synthetic osseous regeneration material under review was deemed suit-able as an alternative to autologous spongiosa for the purpose of filling os -seous defects [24]. The results of this survey thus confirm the data basis from literature with regard to the resorption and unproblematic application of β-TCP. The spectrum of application of β-TCP was extended to include rheu-matologic cases and specific issues from hand and foot surgery covering an observation period of up to 10 years. It was thus possible to document proof of the fact that Cerasorb promotes os -seous regeneration for these indi-cations in the long term with an un-problematic application. In patients with rheumatoid arthritis Cerasorb was also applied for bone regeneration with the typical juxtaarticular osteoporosis, for instance, to prepare joint-maintain-ing surgery at the hand. Filling the im-plant bed for a radial stamp in implant-ing a hand joint prosthesis has also de-livered optimum performance. The bone quality was thus markedly im-proved in patients suffering from rheu-matism.

In the overall evaluation of clinical performance of the 7 possible rates in almost all of the cases the top 2 best marks were awarded. That documents

the favourable procedure of treatment with Cerasorb over the complete peri-od under review. Even despite the fact that the clinical trial presented in this case was an „open“ trial, in other words without a control group, the author nevertheless comes to the conclusion based on his long-year experience that this ceramic material seems to be equal to the use of autologous bone material in the various indications examined here.

Autologous bone material possesses osteoconductive as well as osteoinduc-tive properties. The insufficient avail-ability, the unforeseeability of success, the risk of transmitting germs between the donor region and the recipient re-gion and the morbidity at the location of extraction shall be mentioned [25, 26, 27, 28]. The complication rates are high and the knowledge thereof should inure to the benefit of the patient and thus lead to the implantation of syn-thetic bone remodelling material, if possible. The timely and financial ex-penses in connection with an auto-logous extraction of bone material should be determined objectively and seen in relation to the costs for syn-thetic bone remodelling material.

A key aspect of this clinical trial was focused on the surgical restoration of the hand, an important part of the body for mobility and independence of the patients in concern. It is therefore in particular in connection with hand surgery necessary to exploit all oppor-tunities in order to do justice to the pa-tient’s claim for the best possible result. This seems to be apparently more ap-propriate by filling osseous defects with suitable bone substitution materi-als. Financial deliberations – such as for instance, non-filling defects for reasons of cost – should take a backseat due to the eminent significance of the hand for patients.

30 patients participating in the clinical trial which is reported on had an enchondrome in the shafts of the phalanges. Whereas the enchodromes found in the metaphyses of the long hollow bones often do not cause any symptoms, the enchodromes in the phalanges can cause pain, and patho-logical fractures are possible. This was identified in 4 cases. Even if encho-dromes are classified as benign bone tu-mours as per their definition, a curet-tage is recommended in the majority of

cases in the area of the hand – in par-ticular if pain persists or manual restric-tions exist – followed with refilling by spongiosa or suitable KAM. Here, too, the aim is to maintain the functionality of the hand by performing a stabilising measure in due time. By inserting the bone regeneration material into the de-fect cavity a stabilisation is achieved and osseous regeneration at high speed by the osteoconductivity of the ce-ramic material is enabled, so that po-tential pathological fractures can be avoided at an early point in time. This trial study was able to show that by using Cerasorb β-TCP such defects can be successfully stabilised. In 2005 Ogose and his team successfully ap-plied β-TCP in the curettage and/or ex-cision of tumours in the femur, hu-merus, tibia and at other locations [29]. A further, more recent trial study fur-thermore proved that resorbable β-TCP is optimally suited for filling defects after removing benign and moderately malign bone tumours [30]. The data on the use of β-TCP in this clinical study regarding the removal of bone tumours are thus in line with the data in scien-tific literature.

The indications for the use of pla-telet rich plasma (PRP) in human and dental medicine are multi-facetted: slow-healing wounds, tendinitis, treat-ment of fractures, slow bone regener-ation, arthropathy etc. PRP is fre-quently used above all in oral and maxillofacial surgery. Fields of indi-cation are, however, to an increasing degree also heart, thorax and vascular surgery. Here PRP is above all applied as prophylaxis for wound-healing dis-order. In this clinical trial under review in 59 of 103 cases PRP was applied, as it was expected to promote bone regener-ation and improve the wound healing process. Even if no direct documen-tation of an additional effect was pos -sible in the individual case, the unre-markable procedures of the soft-tissue wounds as well as the radiologically documented bone regeneration seem to speak in favour of a supporting ef-fect.

Conclusion

In summary this clinical trial based on over 100 cases with a period of observa-



10

of the radius. The authors saw β-TCP as an alternative to the use of autologousbone material taken from the iliac crest [21]. In accordance with the data pro-vided a complete resorption of the β-TCP used with simultaneous regener-ation of bones was noticed within theobservation period of 9 months in a further clinical trial conducted with calcaneus fractures [22]. Jakubietz and employees saw no advantage of a β-TCP treatment with intraarticular fracturesof the distal radius in comparison withthe internal fixing alone, however re-ported of an unproblematic appli-cation and resorption of the material [23]. Maus and team reported of over 30 patients with a variety of ortho-paedic indications treated with β-TCP Cerasorb. Post-treatment observations were conducted over a period of up to34 months (on average 9 months). The application of the material was unprob-lematic. No patient suffered from anysigns of local or systemic inflam-mation. Osseous consolidation wasidentified in all defects, thus proving that the synthetic osseous regenerationmaterial under review was deemed suit-able as an alternative to autologous spongiosa for the purpose of filling os -seous defects [24]. The results of thissurvey thus confirm the data basis fromliterature with regard to the resorption and unproblematic application of β-TCP. The spectrum of application of β-TCP was extended to include rheu-matologic cases and specific issuesfrom hand and foot surgery covering an observation period of up to 10 years.It was thus possible to document proof of the fact that Cerasorb promotes os -seous regeneration for these indi-cations in the long term with an un-problematic application. In patients with rheumatoid arthritis Cerasorb was also applied for bone regeneration with the typical juxtaarticular osteoporosis,for instance, to prepare joint-maintain-ing surgery at the hand. Filling the im-plant bed for a radial stamp in implant-ing a hand joint prosthesis has also de-livered optimum performance. Thebone quality was thus markedly im-proved in patients suffering from rheu-matism.

In the overall evaluation of clinical performance of the 7 possible rates inalmost all of the cases the top 2 best marks were awarded. That documents

the favourable procedure of treatment with Cerasorb over the complete peri-od under review. Even despite the fact that the clinical trial presented in this case was an „open“ trial, in other words without a control group, the author nevertheless comes to the conclusion based on his long-year experience that this ceramic material seems to be equal to the use of autologous bone material in the various indications examined here.

Autologous bone material possesses osteoconductive as well as osteoinduc-tive properties. The insufficient avail-ability, the unforeseeability of success, the risk of transmitting germs between the donor region and the recipient re-gion and the morbidity at the locationof extraction shall be mentioned [25, 26, 27, 28]. The complication rates are high and the knowledge thereof should inure to the benefit of the patient and thus lead to the implantation of syn-thetic bone remodelling material, if possible. The timely and financial ex-penses in connection with an auto-logous extraction of bone materialshould be determined objectively and seen in relation to the costs for syn-thetic bone remodelling material.

A key aspect of this clinical trial wasfocused on the surgical restoration of the hand, an important part of thebody for mobility and independence of the patients in concern. It is therefore in particular in connection with handsurgery necessary to exploit all oppor-tunities in order to do justice to the pa-tient’s claim for the best possible result. This seems to be apparently more ap-propriate by filling osseous defects with suitable bone substitution materi-als. Financial deliberations – such as forinstance, non-filling defects for reasons of cost – should take a backseat due to the eminent significance of the hand for patients.

30 patients participating in theclinical trial which is reported on had an enchondrome in the shafts of the phalanges. Whereas the enchodromes found in the metaphyses of the long hollow bones often do not cause any symptoms, the enchodromes in thephalanges can cause pain, and patho-logical fractures are possible. This wasidentified in 4 cases. Even if encho-dromes are classified as benign bone tu-mours as per their definition, a curet-tage is recommended in the majority of

cases in the area of the hand – in par-ticular if pain persists or manual restric-tions exist – followed with refilling by spongiosa or suitable KAM. Here, too, the aim is to maintain the functionality of the hand by performing a stabilisingmeasure in due time. By inserting thebone regeneration material into the de-fect cavity a stabilisation is achievedand osseous regeneration at high speedby the osteoconductivity of the ce-ramic material is enabled, so that po-tential pathological fractures can beavoided at an early point in time. This trial study was able to show that by using Cerasorb β-TCP such defects canbe successfully stabilised. In 2005Ogose and his team successfully ap-plied β-TCP in the curettage and/or ex-cision of tumours in the femur, hu-merus, tibia and at other locations [29]. A further, more recent trial study fur-thermore proved that resorbable β-TCP is optimally suited for filling defects after removing benign and moderatelymalign bone tumours [30]. The data onthe use of β-TCP in this clinical studyregarding the removal of bone tumours are thus in line with the data in scien-tific literature.

The indications for the use of pla-telet rich plasma (PRP) in human and dental medicine are multi-facetted: slow-healing wounds, tendinitis, treat-ment of fractures, slow bone regener-ation, arthropathy etc. PRP is fre-quently used above all in oral and maxillofacial surgery. Fields of indi-cation are, however, to an increasingdegree also heart, thorax and vascular surgery. Here PRP is above all applied as prophylaxis for wound-healing dis-order. In this clinical trial under review in 59 of 103 cases PRP was applied, as it was expected to promote bone regener-ation and improve the wound healingprocess. Even if no direct documen-tation of an additional effect was pos -sible in the individual case, the unre-markable procedures of the soft-tissue wounds as well as the radiologically documented bone regeneration seem to speak in favour of a supporting ef-fect.

Conclusion

In summary this clinical trial based onover 100 cases with a period of observa-



11

tion of up to 10 years documents the fact that Cerasorb as a reliable bone re-generation material applied in hand and foot surgery regularly leads to a complete osseous regeneration without occurrence of side effects and can thus be successfully used.

Conflict of interest: The author de-clares that no conflict of interest exists.

1. Heary RF, Schlenk RP, Sacchieri TA et al.: Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery 2002; 50: 510–516

2. Silber JS, Anderson DG, Daffner SD et al.: Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusi-on. Spine 2003; 28: 134–139

3. Tomford WW: Bone allografts: past, present and future. Cell Tissue Bank. 2000; 1: 105–109

4. Giannoudis PV, Dinopoulos H, Tsiridis E: Bone substitutes: an update. Injury 2005; 36 Suppl 3: 20–27

5. Ghanaati S, Barbeck M, Booms P, Lo-renz J, Kirkpatrick CJ, Sader RA: Poten-tial lack of „standardized“ processing techniques for production of alloge-neic and xenogeneic bone blocks for application in humans. Acta Biomater. 2014; 10: 3557–62

6. Hing KA: Bone repair in the twenty-first century: biology, chemistry or en-gineering? Philos. Trans. A Math. Phys. Eng Sci. 2004; 362: 2821–2850

7. Le Guéhennec L, Layrolle P, and Dacul-si G. A review of bioceramics and fibrin sealant. Eur. Cell Mater. 2004; 8: 1–10

8. Damron TA: Use of 3D beta-tricalcium phosphate (Vitoss) scaffolds in repai-ring bone defects. Nanomedicine 2007; 2: 763–775

9. Khan Y, Yaszemski MJ, Mikos AG et al. Tissue engineering of bone: material and matrix considerations. J. Bone Joint Surg. Am. 2008; 90 Suppl 1: 36–42

10. Wahl DA and Czernuszka JT. Collagen-hydroxyapatite composites for hard tis-sue repair. Eur. Cell Mater. 2006; 11: 43–56

11. Wippermann, BW. Hydroxylapatitke-ramik als Knochenersatzwerkstoff. Ber-lin: Springer; 1997

12. Knabe C, Ducheyne P: Cellular respon-se to bioactive ceramics. In Bioceramics and their clinical applications, Cam-

bridge: Woodhead Publishing Limited, 2008: 133–164

13. Peters F, Reif D: Functional materials for bone regeneration from beta-tricalci-um phosphate. Mat.-wiss.u.Werkstoff-tech. 2004; 35: 203–207

14. Horowitz RA, Mazor Z, Miller RJ et al.: Clinical evaluation alveolar ridge preservation with a beta-tricalcium phosphate socket graft. Compend. Contin. Educ. Dent. 2009; 30: 588–90, 592, 594

15. Horch HH, Sader R, Pautke C: Synthe-tic, pure-phase beta-tricalcium phos-phate ceramic granules (Cerasorb) for bone regeneration in the reconstructi-ve surgery of the jaws. Int. J. Oral Ma-xillofac. Surg. 2006; 35: 708–713

16. Szabo G, Huys L, Coulthard P et al.: A prospective multicenter randomized clinical trial of autogenous bone versus beta-tricalcium phosphate graft alone for bilateral sinus elevation: histologic and histomorphometric evaluation. Int. J. Oral Maxillofac. Implants. 2005; 20: 371–381

17. Zijderveld SA, Zerbo IR, van den Bergh JP et al. Maxillary sinus floor augmen-tation using a beta-tricalcium phospha-te (Cerasorb) alone compared to auto-genous bone grafts. Int. J. Oral Maxillo-fac. Implants. 2005; 20: 432–440

18. Harel N, Moses O, Palti A et al.: Long-term results of implants immediately placed into extraction sockets grafted with beta-tricalcium phosphate: a re-trospective study. J. Oral Maxillofac. Surg. 2013; 71: e63–e68

19. Gruber AA: Practical applications of a bone substitute – Beta-tricalcium phos-phate in hand surgery. Trauma Linc 1999; 2: 50–58

20. Jerosch J, Bader A, Uhr G: Knochen – curasan Taschenatlas spezial. Stuttgart: Thieme; 2002

21. Scheer H, Adolfsson LE: Tricalcium phosphate bone substitute in correcti-

ve osteotomy of the distal radius. Inju-ry 2009; 40: 262–267

22. Hinz P, Wolf E, Schwesinger G et al.: A new resorbable bone void filler in trau-ma: early clinical experience and his-tologic evaluation. Orthopedics 2002; 25: s597–s600

23. Jakubietz MG, Gruenert JG, Jakubietz RG: The use of beta-tricalcium phos-phate bone graft substitute in dorsally plated, comminuted distal radius fractures. J. Orthop. Surg. Res. 2011; 6: 24

24. Maus U, Andereya S, Gravius S et al.: Klinische Erfahrungen mit dem resor-bierbaren Knochenersatzstoff Cera-sorb. Orthopädische Praxis 2006; 43:, 258–261

25. Gerngross H, Burri C, Kinzl L et al.: Complications at removal sites of auto-logous cancellous bone transplants. Aktuelle Traumatol. 1982; 12: 146–152

26. Jäger M, Westhoff B, Wild A et al.: Bone harvesting from the iliac crest. Ortho-päde 2005; 34: 976–90, 992

27. Mazock JB, Schow SR, Triplett RG: Pos-terior iliac crest bone harvest: review of technique, complications, and use of an epidural catheter for postoperative pain control. J. Oral Maxillofac. Surg. 2003; 61: 1497–1503

28. Younger EM, Chapman MW: Morbidity at bone graft donor sites. J. Orthop. Trauma 1989; 3: 192–195

29. Ogose A, Hotta T, Kawashima H et al.: Comparison of hydroxyapatite and be-ta tricalcium phosphate as bone substi-tutes after excision of bone tumors. J. Biomed. Mater. Res. B Appl. Biomater. 2005; 72: 94–101

30. Van Hoff C, Samora JB, Griesser MJ et al.: Effectiveness of ultraporous beta-tricalcium phosphate (vitoss) as bone graft substitute for cavitary defects in benign and low-grade malignant bone tumors. Am. J. Orthop. 2012; 41: 20–23

Literature

Dr. med. Alfred Gruber

FA für Plastische und Ästhetische

Chirurgie

RTZ Nürnberg

Schweinauer Hauptstraße 12

90441 Nürnberg

[email protected]

Correspondence address



11

tion of up to 10 years documents the fact that Cerasorb as a reliable bone re-generation material applied in hand and foot surgery regularly leads to acomplete osseous regeneration without occurrence of side effects and can thusbe successfully used.

Conflict of interest: The author de-clares that no conflict of interest exists.

1. Heary RF, Schlenk RP, Sacchieri TA et al.: Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery 2002; 50: 510–516

2. Silber JS, Anderson DG, Daffner SD et al.: Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusi-onon. SpSpineine 202003;03; 2828: 1: 134–34–139139

3. Tomford WW: Bone allografts: past, present and future. Cell Tissue Bank. 2000; 1: 105–109

4. Giannoudis PV, Dinopoulos H, Tsiridis E: Bone substitutes: an update. Injury 2005; 36 Suppl 3: 20–27

5. Ghanaati S, Barbeck M, Booms P, Lo-renz J, Kirkpatrick CJ, Sader RA: Poten-tial lack of „standardized“ processing techniques for production of alloge-neic and xenogeneic bone blocks for application in humans. Acta Biomater.2012014;4; 10:10: 35355757–6262

6. Hing Kg A: Bone repap ir in the twenty-yfirst century: biology, chemistry or en-gineering? Philos. Trans. A Math. Phys. Eng Sci. 2004; 362: 2821–2850

7. Le Guéhennec L, Layrolle P, and Dacul-si G. A review of bioceramics and fibrin sealant. Eur. Cell Mater. 2004; 8: 1–10

8. Damron TA: Use of 3D beta-tricalcium phosphate (Vitoss) scaffolds in repai-ring bone defects. Nanomedicine 2007; 2: 763–775

9. Khan Y, Yaszemski MJ, Mikos AG et al.Tissue engineering of bone: material

dand matrix cons diderations. J. Bone Joint Surg. Am. 2008; 90 Suppl 1: 36–42

10. Wahl DA and Czernuszka JT. Collagen-hydroxyapatite composites for hard tis-sue repair. Eur. Cell Mater. 2006; 11: 43–56

11. Wippermann, BW. Hydroxylapatitke-ramik als Knochenersatzwerkstoff. Ber-lin: Springer; 1997

12. Knabe C, Ducheyne P: Cellular respon-se to bioactive ceramics. In Bioceramics and their clinical applications, Cam-

bridge: Woodhead Publishing Limited, 2008: 133–164

13. Peters F, Reif D: Functional materials for bone regeneration from beta-tricalci-um phosphate. Mat.-wiss.u.Werkstoff-tech. 2004; 35: 203–207

14. Horowitz RA, Mazor Z, Miller RJ etal.: Clinical evaluation alveolar ridgeprepreserservatvationion wiwithth a ba betaeta-tr-tricaicalcilciumumphosphate socket graft. Compend.Contin. Educ. Dent. 2009; 30: 588–90, 592, 594

15. Horch HH, Sader R, Pautke C: Synthe-tic, pure-phase beta-tricalcium phos-phate ceramic granules (Cerasorb) for bone regeneration in the reconstructi-ve surgery of the jaws. Int. J. Oral Ma-xillofac. Surg. 2006; 35: 708–713

16. Szabo G, Huys L, Coulthard P et al.: A prospective multicenter randomized clinical trial of autogenous bone versus betbeta ta-tricricalcalciumium phphosposphathate ge grafraft at alonlonee for bilateral sinus elevation: histologgic and histomorphometric evaluation.Int. J. Oral Maxillofac. Implants. 2005; 20: 371–381

17. Zijderveld SA, Zerbo IR, van den Bergh JP et al. Maxillary sinus floor augmen-tation using a beta-tricalcium phospha-te (Cerasorb) alone compared to auto-genous bone grafts. Int. J. Oral Maxillo-fac. Implants. 2005; 20: 432–440

18. Harel N, Moses O, Palti A et al.: Long-term results of implants immediatelyplaced into extraction sockets grafted with bh beta-tricallcium hpho hsphate: a re-trospective study. J. Oral Maxillofac. Surg. 2013; 71: e63–e68

19. Gruber AA: Practical applications of a bone substitute – Beta-tricalcium phos-phate in hand surgery. Trauma Linc1999; 2: 50–58

20. Jerosch J, Bader A, Uhr G: Knochen – curasan Taschenatlas spezial. Stuttgart:Thieme; 2002

21. Scheer H, Adolfsson LE: Tricalcium phosphate bone substitute in correcti-

ve osteotomy of the distal radius. Inju-ry 2009; 40: 262–267

22. Hinz P, Wolf E, Schwesinger G et al.: Anew resorbable bone void filler in trau-ma: early clinical experience and his-tologic evaluation. Orthopedics 2002;25: s597–s600

23. Jakubietz MG, Gruenert JG, Jakubietz RG:RG: ThThe ue usese ofof betbeta-ta-tricricalcalciumium phphos-os-phate bone graft substitute in dorsallyplated, comminuted distal radius fractures. J. Orthop. Surg. Res. 2011; 6: 24

24. Maus U, Andereya S, Gravius S et al.: Klinische Erfahrungen mit dem resor-bierbaren Knochenersatzstoff Cera-sorb. Orthopädische Praxis 2006; 43:,258–261

25. Gerngross H, Burri C, Kinzl L et al.: Complications at removal sites of auto-logous cancellous bone transplants. AktAktueluellele TraTraumaumatoltol 1. 1982982; 1; 12:2: 146146 15–1522

26. JäJ gerg M,, Westhoff B,, Wild A et al.: Bone harvesting from the iliac crest. Ortho-päde 2005; 34: 976–90, 992

27. Mazock JB, Schow SR, Triplett RG: Pos-terior iliac crest bone harvest: review of technique, complications, and use of an epidural catheter for postoperative pain control. J. Oral Maxillofac. Surg.2003; 61: 1497–1503

28. Younger EM, Chapman MW: Morbidity at bone graft donor sites. J. Orthop. Trauma 1989; 3: 192–195

29. Ogose A, Hotta T, Kawashima H et al.: Comparison of hf h dydroxyapatite a dnd bbe-ta tricalcium phosphate as bone substi-tutes after excision of bone tumors. J. Biomed. Mater. Res. B Appl. Biomater. 2005; 72: 94–101

30. Van Hoff C, Samora JB, Griesser MJ etal.: Effectiveness of ultraporous beta-tricalcium phosphate (vitoss) as bonegraft substitute for cavitary defects inbenign and low-grade malignant bone tumors. Am. J. Orthop. 2012; 41:20–23

Literature

Dr. med. Alfred Gruber

FA für Plastische und Ästhetische

Chirurgie

RTZ Nürnberg

Schweinauer Hauptstraße 12

90441 Nürnberg

[email protected]

Correspondence address


mailto:[email protected]


www.curasan.com

CERASORB®-Promise

Keeps its words in bone regeneration.

CERASORB® – Always First Choice.

CERASORB® is -TCP –the purest bioceramic material

The ultimate in safe and reliable bone regeneration

Supreme quality you can rely on

Maximized clinical success

110

87

00

131

_0

3–2

017

_0

01

www.curasan.com

CERASORB®-Promise

Keeps its words in bone regeneration.

CERASORBCERASORB®® – Always First Chays Firrstt Choicoicce.ce

CERASORB® is -TCP –the purest bioceramic material

The ultimate in safe and mat n safe anreliable bone regeneratione bon regennera ion

Supreme quality you can rely on

Maximized clinical success

110

87

00

131

_0

3–2

017

_0

01

http://www.curasan.com/

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EN Sonderdruck Curasan Knochenersatz mit Cerasorb 106379008