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

Wyeth

Status and phase: Completed; Phase 2

Conditions: Fractures

Treatments: Drug: rhBMP-2/CPM; Other: surgical intervention alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384358

B1921004

3100N7-211

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

A

Experimental group

Description:

1.0 mg/mL rhBMP-2/CPM + surgical fixation

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

B

Experimental group

Description:

2.0 mg/mL rhBMP-2/CPM + surgical fixation

Treatment:

Drug: rhBMP-2/CPM

Drug: rhBMP-2/CPM

C

Other group

Description:

Control: Surgical fixation

Treatment:

Other: surgical intervention alone