© Deutscher Ärzte-Verlag | OUP | 2014; 3 (12) · © Deutscher Ärzte-Verlag | OUP | 2014; 3 (12) A. Breil-Wirth1, ... bei denen eine Augmentati- ... results in terms of osseointegration;

© Deutscher Ärzte-Verlag | OUP | 2014; 3 (12)


A. Breil-Wirth1, J. Jerosch1

Application of Cerasorb Foam in Orthopaedics – a Prospective Trial

SummaryObjective: There are many bone replacement ma-

terials available in the market. The aim of this prospective trial was to examine the effectiveness and tolerability of Ce-rasorb Foam, a β-tricalcium phosphate (β-TCP) which is em-bedded in porcine collagen. Material and methods: 55 Patients, aged from 17 to 79, with need of bone augmentation or replacement were in-cluded in this trial. Patients with local or systemic infections, severe osteoporosis or with medications, which compromise wound healing, were excluded. Clinical and native radiology checkups were performed before as well as 6 weeks, 3, 6 and 12 months after surgery. 28 patients have completed the 1-year checkup to date. We evaluated the tolerability, re-sorption of the bone replacement material and bony fusion. Cerasorb Foam is a synthetic composite of 85 weight per-cent (wt%) β-TCP Cerasorb and 15 wt% collagen.Results: No patient showed material-associated compli-cations or intolerances. The resorption of Cerasorb Foams among the patients commenced radiographically visible after 6 weeks to 3 months and was largely completed after 12 months. Also the bony fusion had been fully developed after 12 months.Clinical Conclusion: The filling or augmentation of defects is a regular necessity in orthopaedics and traumatology. Cera-sorb Foam provides an easy-to-apply and well-effective ce-ramic bone replacement material with a wide range of appli-cations.

Keywords: ceramic bone replacement, Cerasorb, β-tricalcium phosphate

Citation

Breil-Wirth A, Jerosch J. Application of Cerasorb Foam in Ortho-

paedics – a Prospective Trial.

OUP 2014; 10: 608–615 DOI 10.3238/oup.2014.0608–615

ZusammenfassungFragestellung: Es sind zahlreiche Knochenersatz materialien auf dem Markt verfügbar. In dieser prospektiven Studie sollte die Effizienz und Verträglichkeit von Cerasorb Foam, einem in porcinem Kollagen eingelagerten β-Tri calciumphosphat untersucht werden. Material und Methode: Eingeschlossen wurden 55 Patien-ten im Alter von 17–79 Jahren, bei denen eine Augmentati-on oder Knochenersatz erforderlich war. Ausgeschlossen wurden Patienten mit lokalen oder systemischen Infektionen, ausgeprägter Osteoporose oder die Wundheilung kompro-mittierenden Medikamenten. Klinische und nativradiologi-sche Kontrollen wurden prä OP, 6 Wochen, 3, 6 und 12 Monate post OP durchgeführt. 28 Patienten haben die Jahreskontrolle bis dato erreicht. Beurteilt wurden die Ver-träglichkeit, die Resorption des Knochenersatzmaterials und die knöcherne Durchbauung. Cerasorb Foam ist ein syntheti-sches Komposit aus 85 Gewichtsprozent (Gew-%) β-TCP Cerasorb und 15 Gew.-% Kollagen.Ergebnisse: Bei keinem Patienten kam es zu material -assoziierten Komplikationen oder Unverträglichkeiten. Die Resorption des Cerasorb Foams setzte bei den Patienten nach 6 Wochen bis 3 Monaten radiologisch sichtbar ein und war nach 12 Monaten weitestgehend abgeschlossen. Die knöcherne Durchbauung war nach 12 Monaten ebenfalls ausgeprägt.Klinisches Fazit: Die Auffüllung oder Augmentation von De-fekten ist eine regelmäßige Notwendigkeit in der Orthopädie und Unfallchirurgie. Cerasorb Foam stellt ein leicht zu ver-arbeitendes und gut wirksames keramisches Knochenersatz-material mit breitem Anwendungsspektrum dar.

Schlüsselwörter: keramischer Knochenersatz, Cerasorb, β-Tricalciumphosphat

Zitierweise

Breil-Wirth A, Jerosch J. Anwendung von Cerasorb Foam in der Or-

thopädie – eine prospektive Studie.

OUP 2014; 10: 608–615 DOI 10.3238/oup.2014.0608–615

1 Department of Orthopaedics, Traumatology and Sports Medicine, Johanna Etienne Hospital, Neuss

3WISSENSCHAFT / RESEARCH Übersichtsarbeit / Review


this way, the collagen improves the osteoconductive properties of the granules and in addition causes an os-teoinduction. Collagen-ceramic com-posites have already been successfully used in spinal surgery [9, 10, 11].

In the present prospective trial, the handling, compatibility and osseous integration of Cerasorb Foam was in-vestigated.

Material and methods

Bone replacement material: For the clinical study, a synthetic highly po-rous composite, consisting of 85 wt% phase-pure (> 99 %) β-TCP (Cerasorb) and 15 wt% porcine collagen (Cerasorb Foam) was provided by the manufac-turer. The collagen proportion serves to embed the granules and fixes them. In addition, the collagen is to facilitate the ingrowth of blood vessels and thus to in-

duce improved osteoconductive prop-erties. By the 85 wt% granules a high volume stability of the ceramic is to be achieved after reduction of the faster resorbing collagen. The material is of-fered in 2 types, which are used in the study. The Cerasorb Mouldable Foam can – after enrichment with blood – be kneaded and plastically shaped. Thus, it can be modeled according to the shape of the defect. The Cerasorb Flex-ible Foam is elastic after enrichment with blood and thus fills defects flaw-lessly after insertion. The granulate has a total porosity of about 65% and a pore size of 0.1–500 microns.

The Cerasorb Foam was provided in different sizes:• 25 mm × 50 mm × 4 mm (5 cc);• 25 mm × 100 mm × 4 mm (10 cc).However, both types can be cut at will.

To study the material, a single-center prospective trial was carried

out. Included were patients, where augmentation or bone replacement was required. Here, the range of indi-cations has been set wide. 16 patients had trauma surgery indications (5 clavicle, 6 tibia, 5 humerus fractures).

In 10 patients, arthrodesis was performed (including 8 ankle arth-rodeses). In 9 patients defects due to cysts or previous surgeries were filled. In 11 patients defects due to bone har-vesting were filled. In other 7 patients a knee-near corrective osteotomy was performed (Fig. 2, 3).

Prior to insertion, the material should be soaked with blood from the defect in order to make use of the plastic or elastic properties and to promote integration by enrichment with growth factors and bone marrow cells.

Excluded were patients with local or systemic infections, severe meta-bolic disorders, consumptive diseases, severe osteoporosis, radiation therapy or medications, which compromise wound healing. Also direct contact to open epiphyseal plates or the joint space as well as known allergies to porcine proteins were exclusion crite-ria.

The preoperative status was docu-mented clinically and with native radiology. Clinical and native radio-logical controls were performed 6 weeks, 3 and 6 months and one year post op. We evaluated the absorption of the bone replacement material and the bony fusion on the basis of the X-ray image. Also the tolerability of the material has been clinically as-sessed on the basis of complaints and findings.

Patient population: From January 2012 to August 2013 a total of 55 pa-

Figure 4a–e: Formation of new bone. Categories: a) none b) slight c) moderate, d) pronounced, e) complete. Cerasorb Foam

(25 mm x 100 mm x 4 mm (10 cc)).

Figure 5a–c: Resorption. Categories: a) none b) partial c) complete. Cerasorb Foam (2 times

25 mm x 100 mm x 4 mm (10 cc)).

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A. Breil-Wirth, J. Jerosch:Application of Cerasorb Foam in Orthopaedics – a Prospective TrialAnwendung von Cerasorb Foam in der Orthopädie – eine prospektive Studie


blood, smaller pieces could be easily cut out from the sponge if necessary. After soaking both the mouldable and the flexible foam could easily be in-serted and attached to the location of the defect. Thanks to the spongy con-sistency, the material remained stuck at the desired location. In the post-operative radiographs no change in position of the material was observed. Also incorrect attachments in the sur-rounding tissue did not occur.

The tolerability of the material was very satisfactory. There were no infections, rejection reactions or other Cerasorb-associated compli-cations. The formation of new bone and the resorption of the material also took place very satisfactorily. After 12 months all patients showed the greatest possible absorption of the introduced granules. Only in case of very large quantities of Cera-sorb Foam remnants of ceramics could be seen. In parallel with the degradation of the granules a nearly complete bone regeneration after 12 months appeared. No differences in

the integration behaviour of the flexible or mouldable type could be detected. Also the body weight of the patients had no effect on the inte-gration. Only a high patient age re-sulted in a slower formation and a delayed degradation after half a year. In the annual inspection no differ-ences were observed in the elderly, though. This is not surprising, since the bone metabolism, especially the formation, is reduced in old, often osteoporotic bone. All in all, thus the properties of the granules with respect to the integration observed in previous studies were confirmed [8, 6]. By combining with collagen a clear improvement in handling and at least no disadvantage of effective-ness could be identified.

Finally Cerasorb Foam must cer-tainly be regarded as an alternative to autologous cancellous bone. The ma-terial showed good properties in terms of integration, was almost com-pletely degraded after 12 months, avoiding donor site morbidity associ-ated with autologous cancellous

bone. Both in the orthopaedic and in the trauma surgery applications car-ried out in the course of this trial, it was found to be very effective. Whether there is particular suitability of the material for certain medical in-dications or patient groups, needs to be further investigated. The embed-ding in porcine collagen improved processing properties, allowing good results in terms of osseointegration; a superiority over granulate without collagen, however, should be further examined.Conflict of interest: The authors de-clare that according to the guidelines of the International Committee of Medical Journal Editors, there is no conflict of interest.

Prof. Dr. med. Dr. h.c. Jörg JeroschDepartment of Orthopaedics, Trauma-tology and Sports MedicineJohanna Etiennne HospitalAm Hasenberg 46, 41452 [email protected]

Mailing address

Figure 10a–d: M, 49. Clavicle fracture Cerasorb Foam (25 mm x 50 mm x 4 mm). a) pre OP, b) 6 weeks c) 3 months, d) 6 months after surgery.

Figure 11a–d: M, 32. Condition after removal of benign tumours, currently removing the Palacos spacer and filling with Cerasorb Foam (25 mm

x 100 mm x 4 mm) and iliac crest cancellous bone; a) pre OP, b) 6 weeks c) 3 months, d) 6 months after surgery.

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A. Breil-Wirth, J. Jerosch:Application of Cerasorb Foam in Orthopaedics – a Prospective Trial

Anwendung von Cerasorb Foam in der Orthopädie – eine prospektive Studie


Figure 14a–d: W, 45. Iliac crest extraction left, a) after surgery, b) 3 months, c) 6 months d) 12 months postoperatively; Cerasorb Foam

(25 mm x 50 mm x 4 mm).

Figure 12a–d: W, 24. Tibial plateau fracture after horse kick a) pre OP, b) 3 months, c) 6 months d) 12 months postoperatively. Cerasorb Foam

(5 times 25 mm x 50 mm x 4 mm and 1 time 25 mm x 100 mm x 4 mm).

Figure 13a–d: W, 44. Cyst humeral head, a) after surgery, b) 3 months, c) 6 months d) 12 months postoperatively. Cerasorb Foam

(25 mm x 50 mm x 4 mm) and iliac crest cancellous bone.

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A. Breil-Wirth, J. Jerosch:Application of Cerasorb Foam in Orthopaedics – a Prospective TrialAnwendung von Cerasorb Foam in der Orthopädie – eine prospektive Studie


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Literature


A. Breil-Wirth, J. Jerosch:Application of Cerasorb Foam in Orthopaedics – a Prospective Trial

Anwendung von Cerasorb Foam in der Orthopädie – eine prospektive Studie



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© Deutscher Ärzte-Verlag | OUP | 2014; 3 (12) · © Deutscher Ärzte-Verlag | OUP | 2014; 3 (12) A. Breil-Wirth1, ... bei denen eine Augmentati- ... results in terms of osseointegration;