Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a XXXX -Collagen Matrix.

@entity1 @entity28687 @entity158 @entity13065
BACKGROUND: Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant @entity1 platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive @entity13065 ( @entity28687 )-collagen matrix versus autograft in ankle and hindfoot fusions. METHODS: Seventy-five @entity1 requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/ @entity28687 -collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. @entity1 underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/ @entity28687 -collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale @entity158 score, American Orthopaedic Foot _ Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. RESULTS: Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/ @entity28687 -collagen-treated @entity1 and 100 of 154 (65%) autograft-treated @entity1 (P < .001). Mean time to fusion was 14.3    8.9 weeks for rhPDGF-BB/ @entity28687 -collagen @entity1 versus 19.7    11.5 weeks for autograft @entity1 (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/ @entity28687 -collagen @entity1 and 120 of 154 (78%) autograft @entity1 (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections. CONCLUSIONS: Application of rhPDGF-BB/ @entity28687 -collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the @entity158 and morbidity associated with autograft harvesting. LEVEL OF EVIDENCE: Therapeutic Level I, prospective randomized study.
