A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

Study Overview
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Brief Summary
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The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.

Official Title
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A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture

Conditions
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Fractures

Intervention / Treatment
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* Drug: rhBMP-2/CPM
* Drug: rhBMP-2/CPM
* Drug: rhBMP-2/CPM
* Drug: rhBMP-2/CPM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature, male and female subjects who are at least 18 years old. Closed diaphyseal tibial fracture. Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury. Exclusion Criteria: Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing. Planned procedure(s) to stimulate fracture healing after intramedullary nailing. Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


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> <br> |
| Experimental: B<br>2.0 mg/mL rhBMP-2/CPM + surgical fixation | Drug: rhBMP-2/CPM<br> <br> |
| Active Comparator: C<br>Buffer/CPM + surgical fixation Intervention | Drug: rhBMP-2/CPM<br> <br> |
| Other: D<br>Standard of Care: Surgical fixation intervention | Drug: rhBMP-2/CPM<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations. |  | efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months |  | 12 months |