Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Radius Fractures
About this trial
This is an interventional treatment trial for Radius Fractures focused on measuring Distal Radius Fractures
Eligibility Criteria
Inclusion Criteria: Adults aged 50 to 80 years of age; alert and oriented to person, place, and time. Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures. Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study. Other inclusion applies. Exclusion Criteria: Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit). Fracture fixation by other means (eg, plate and screw fixation). Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated. Other exclusion applies.