Status:
COMPLETED
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Radius Fractures
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
Brief Summary
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00161629
Start Date
September 1 2005
End Date
January 1 2007
Last Update
December 5 2007
Active Locations (7)
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1
Kuopio, Finland, 70211
2
Oulu, Finland, 70211
3
Turku, Finland, 20520
4
Créteil, France, 94010