Status:
UNKNOWN
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
Lead Sponsor:
Inion Oy
Conditions:
Distal Fibular Fracture
Bimalleolar Fracture
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradabl...
Eligibility Criteria
Inclusion
- Patient is willing and able to understand, sign and date the study-specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
- Patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated Weber class B or any Weber class C fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured
- Fresh/acute fractures (seen within seventy-two hours of the injury)
- Aged between 18 to 60 years
- Skeletally mature
- Willingness to accept randomisation either to the test or control group
- Willingness and ability to comply with all investigation procedures pre- and post-operation.
Exclusion
- Contraindications of operative internal plate fixations
- Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:
- active or potential infection
- patient's conditions, including limited blood supply, insufficient quantity or quality of bone, and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)
- high-load bearing applications
- Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
- Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
- Previous ankle fracture
- Patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight)
- Bone malignancy
- Osteomyelitis
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00864877
Start Date
May 1 2009
Last Update
March 19 2009
Active Locations (1)
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1
Leeds General Infirmary
Leeds, United Kingdom, LS13EX