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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fractures

Intervention / Treatment
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* Drug: rhBMP-2/CPM
* Drug: rhBMP-2/CPM
* Other: surgical intervention alone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>1.0 mg/mL rhBMP-2/CPM + surgical fixation | Drug: rhBMP-2/CPM<br>* one time injection of 3-5 mL test article at time of internal fracture fixation<br>|
| Experimental: B<br>2.0 mg/mL rhBMP-2/CPM + surgical fixation | Drug: rhBMP-2/CPM<br>* one time injection of 3-5 mL test article at time of internal fracture fixation<br>|
| Other: C<br>Control: Surgical fixation | Other: surgical intervention alone<br>* surgical internal fixation of fracture defines the standard of care group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone. |  | upon completion 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication. |  | 6 months follow-up | 
| To estimate the success and failure rates associated with key fracture outcomes. |  | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractures