Pilot Study of Safety and Performance of a Mixture of Calcium Phosphate Granules Combined with Cellulosic-Derived Gel after Tunnel Filling Created during Surgical Treatment of Femoral Head Aseptic Osteonecrosis
The biomaterial studied here is a composite associating a mineral phase of an intimate nanoscale melting of hydroxyapatite and beta tri calcium phosphate and an aqueous phase containing a synthetic polymer derived from cellulose HPMC (hydroxyl propyl methyl cellulose), marketed under name MBCP Gel (FDA approval, Biomatlante manufacturer). The present exploratory study aim was to study the safety of MBCP-gel, and to determine in the osseous healthy area the performance of MBCP gel. We expected to prove bone ingrowth into the osseous cavities created during drilling biopsy of the aseptic osteonecrosis of femoral head. The current results obtained in the first two patients with 1 year follow up demonstrate the resorption and bone ingrowth with trabecular bone architecture in the hole created into the femoral neck.
Guy Daculsi and Pierre Layrolle
T. Fabre et al., "Pilot Study of Safety and Performance of a Mixture of Calcium Phosphate Granules Combined with Cellulosic-Derived Gel after Tunnel Filling Created during Surgical Treatment of Femoral Head Aseptic Osteonecrosis", Key Engineering Materials, Vols. 361-363, pp. 1295-1298, 2008