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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-06-30

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.

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Detailed Description

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Conditions

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Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

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

Group Type EXPERIMENTAL

rhBMP-2/CPM

Intervention Type DRUG

one time injection of 3-5 mL test article at time of internal fracture fixation

B

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

Group Type EXPERIMENTAL

rhBMP-2/CPM

Intervention Type DRUG

one time injection of 3-5 mL test article at time of internal fracture fixation

C

Control: Surgical fixation

Group Type OTHER

surgical intervention alone

Intervention Type OTHER

surgical internal fixation of fracture defines the standard of care group

Interventions

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rhBMP-2/CPM

one time injection of 3-5 mL test article at time of internal fracture fixation

Intervention Type DRUG

rhBMP-2/CPM

one time injection of 3-5 mL test article at time of internal fracture fixation

Intervention Type DRUG

surgical intervention alone

surgical internal fixation of fracture defines the standard of care group

Intervention Type OTHER

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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No