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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

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.