95. Présentation d’une étude clinique de suivi de cas “investigateur driven”

S. Reppenhagen, P. Raab, U. Nöth (Würzburg, Allemagne)
Fibrin/HA/ß-TCP composite in use of benign bone tumors and tumorlike lesions

University of Würzburg, Orthopädische Klinik König-Ludwig-Haus, Würzburg, Germany


For the therapy of large bone defects from bone diseases such as benign bone tumors or tumorlike lesions the use of autologous cancellous bone is still the most common and effective treatment. But the amount of autologous cancellous bone is limited and the complication rate harvesting bone from the iliac crest is 1 – 2 % in the literature. As an alternative synthetic biomaterials such as hydroxyapatite (HA) or beta-tricalciumphosphate (beta-TCP) have been in clinical use in different combinations for several decades. The ideal bone substitute biomaterial has to be biocompatible, resorbable and osteoinductive. The use of biomaterials such as HA and beta-TCP in combination with fibrin sealant represent a new and promising approach. A biphasic ceramic bone substitute material (TricOsÆ, Baxter) in combination with diluted fibrin sealant (TissuColÆ, Baxter) was examined as an alternative to autologous bone graft in the therapy of benign bone defects and tumorlike lesions.


In a clinical study bone defects resulting from benign tumors and tumorlike lesions in 51 patients have been treated with a HA/beta-TCP granular biomaterial consisting of 60 % HA and 40 % beta-TCP (TricOsÆ, Baxter) in combination with 1:100 (5 IU/ml) diluted fibrin sealant (TissuColÆ, Baxter). Patients were of age 8 – 69 years (mean 30.6 years). Bone defects treated included 14 benign tumors and 37 tumorlike lesions of varying entity. The size of bone defects ranged from 2 cm_ to 35 cm_ (mean 12.1 cm_). Time of follow up was 12 – 36 months (mean 17.5 months). All lesions were determined as Enneking stadium II or III. In all cases a biopsy for histological evaluation was obtained to verify the diagnosis. Intralesional curettage was performed and the defect was filled with the composite The study protocol was approved by a local ethics committee. X-ray analysis has been performed postoperatively, after 6 weeks, 3, 6 and 12, 24 and 36 months. High-resolution MRI or CT was performed in selected cases after 12 months to evaluate the bone defect filling and biomaterial biodegradability of the implanted material. Histological analysis was performed in cases of revision.


Data of x-ray and analysis of MRI and CT showed a complete filling of the bone defects in 50 patients after up to 36 months. Postoperative fractures were not observed. Revision surgery had to be performed in one case with solitary cyst due to reoccurrence. Histological analysis of the specimen showed new bone formation and osseointegration of the biomaterial. Residual granules were also found. There was no total resorption of biomaterial after up to 36 months as determined by x-ray and MRI. TricOsÆ material in combination with diluted fibrin sealant has shown to be easy to handle for the surgeon, eliminating the risk of donor site morbidity and infection for the patient and reducing the time of surgery.


Fibrin/HA/_-TCP composite is a safe and easy to handle bone substitute biomaterial. There was no total resorption after up to 36 months. Long term clinical follow up and histological examinations have to evaluate the resorbability of the material and new bone formation in large bone lesions.

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