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
Overview
- Phase
- Phase 2
- Intervention
- rhBMP-2/CPM
- Conditions
- Fractures
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 367
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Intervention: rhBMP-2/CPM
B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Intervention: rhBMP-2/CPM
C
Buffer/CPM + surgical fixation Intervention
Intervention: rhBMP-2/CPM
D
Standard of Care: Surgical fixation intervention
Intervention: rhBMP-2/CPM
Outcomes
Primary Outcomes
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.
Time Frame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra
Secondary Outcomes
- Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months(12 months)