Abstract
This prospective randomized multicenter study compares two methods of bone defect treatment in tibial plateau fractures: a bioresorbable calcium phosphate paste (Alpha-BSM) that hardens at body temperature to give structural support versus Autogenous iliac bone graft (AIBG).
One hundred and eighteen patients were enrolled with a 2:1 randomization, Alpha-BSM to AIBG. There was a significant increased rate of non-graft related adverse affects and a higher rate of late articular subsidence (three to nine month period) in the AIBG group.
A bioresorbable calcium phosphate material is recommended in preference to the gold standard of AIBG for bone defects in tibial plateau fractures.
This prospective randomized multicenter study was undertaken to compare two methods of bone defect treatment: a bioresorbable calcium phosphate paste (Alpha-BSM –DePuy, Warsaw, IN) that hardens at body temperature to give structural support and is gradually resorbed by a cell-mediated bone regenerating mechanism versus Autogenous iliac bone graft (AIBG).
One hundred and eighteen adult acute closed tibial plateau fractures, Schatzker grade two to six were enrolled prospectively from thirteen study sites in North America from 1999 to 2002. Randomization occurred at surgery with a FDA recommendation of a 2–1 ratio, Alpha BSM (seventy-eight fractures) to AIBG (forty fractures). Only internal fixation with standard plate and screw constructs was permitted. Follow-up included standard radiographs and functional studies at one year, with a radiologist providing independent radiographic review.
The two groups exhibited no significant differences in randomization as to age, sex, race, fracture patterns or fracture healing. There was however, a significant increased rate of non-graft related adverse affects in the AIBG group. There was an unexpected significant finding of a higher rate of late articular subsidence in the three to nine month period in the AIBG group.
Recommendations for the use of AIBG for bone defects in tibial plateau fractures should be discouraged in favor of bioresorbable calcium phosphate material with the properties of Alpha BSM. We believe further randomized studies using AIBG as a control group for bone defect support of articular fractures are unjustified.
A bioresorbable calcium phosphate material is recommended in preference to the gold standard of AIBG for bone defects in tibial plateau fractures.
Funding: DePuy, Warsaw, IN.
Correspondence should be addressed to Cynthia Vezina, Communications Manager, COA, 4150-360 Ste. Catherine St. West, Westmount, QC H3Z 2Y5, Canada
