Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur

The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

Inclusion Criteria:

• Age 55 or older.
• Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
• Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.

Exclusion Criteria:

• Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
• Previous arthroplasty of contralateral (unaffected) hip.
• Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.