Session II - Tibia

Fri., 10/8/04 Tibia, Paper #9, 10:58 am

The Gold Standard in Tibial Plateau Fractures? A Prospective Multicenter Randomized Study of AIBG vs. Alpha-BSM

Thomas A. Russell, MD (n); Ross K. Leighton, MD; (a-DePuy, USA;

a,b,e-ETEX); Robert W. Bucholz, MD (n); Charles N. Cornell, MD (n);

Sam Agnew, MD; Robert F. Ostrum, MD (n); James A. Goulet, MD (n);

B. H. Berrey, MD; Brian Davison, MD; Thomas Gruen, MS;

Mark S. Vrahas, MD; Alan L. Jones, MD; Andrew Pollak, MD;

Peter O'Brien, MD; Thomas F. Varecka, MD

See membership directory for authors' institutions of this multicenter study.

Purpose: This prospective randomized multi-center study was undertaken to compare treatment of the subarticular bone defect in tibial plateau fractures with conventional autogenous iliac graft (AIBG) and with a bioresorbable calcium-phosphate paste (alphaBSM, Bone Substitute Material, ETEX, Cambridge, Massachusetts and DePuy, Warsaw, Indiana) that hardens at body temperature to give structural support and is gradually resorbed by a cell-mediated bone-regenerating mechanism.

Methods: A total of 119 adult patients with 120 Schatzker grade 1-6 acute closed tibial plateau fractures were enrolled in 12 study sites in North America from 1999 to 2002. All patients were prospectively enrolled with Institutional Review Board supervision. Randomization occurred at surgery with a 2:1 ratio of alphaBSM (82 fractures) to AIBG (38 fractures) for treatment of the subarticular defect. After open reduction, a standard plate and screw construct was used for internal fixation. Follow-up included standard radiographs and functional studies at 1 year. A single radiologist provided independent radiographic review at the final follow-up.

Results: Age, sex, race, and fracture pattern were comparable for patients in the two groups. However, a significantly increased rate of graft-related adverse affects was observed in the AIBG group. There was an unexpected statistically significant finding of a higher rate of articular subsidence in the 3-to-12 month period in the AIBG group patients.

Conclusion: Bioresorbable calcium phosphate materials, such as alphaBSM, appear to be a better choice for the treatment of subarticular defects in tibial plateau fractures than AIBG. Because of the frequency of adverse effects with use of AIBG, especially late articular subsidence, randomized studies using AIBG as a control group seem unjustified.