Fractures
Conditions
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.
Interventions
DRUGrhBMP-2/CPM
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Argentina, Australia, Brazil, Canada, Finland, France, Germany, India, Latvia, Mexico, Poland, Romania, Serbia, Slovenia, Spain, Sweden, United Kingdom, United States
Outcome results
None listed