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Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

Last updated on March 15, 2019

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Study Location
Kuopio, , 70211 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Radius Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00161629
Pfizer
Completed
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

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[email protected]

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