Operative Versus Non Operative Treatment for Unstable Ankle Fractures (NCT00336752) | Clinical Trial Compass
CompletedNot Applicable
Operative Versus Non Operative Treatment for Unstable Ankle Fractures
Canada80 participantsStarted 2003-06
Plain-language summary
The purpose of the study is to compare functional outcomes and recovery following surgical and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary objectives are to compare the re-operation rate, time to union and complications between the two treatment groups.
The primary research questions:
1. Does surgery provide a better functional outcome compared to non operative treatment of undisplaced, unstable fractures?
2. Do patients with these fractures return to activities faster after operative or non operative treatment?
3. Are complications more common with operative or non operative care?
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Skeletally mature male or female \< 65 years of age
✓. Unstable ankle on stress exam: medial clear space ³ 5 mm: no Mortise shift on static radiographs
✓. Unilateral Weber B fibular fractures
✓. Closed fracture
✓. Provision of informed consent -
Exclusion criteria
✕. Fractures not amenable to surgical treatment
✕. Pathologic fracture
✕. Associated injuries to the foot, ankle, tibia, or knee
✕. Associated medial malleolus fracture
✕. Surgical delay of \>2 weeks from time of injury
✕. Previous fracture or retained hardware in the affected limb
What they're measuring
1
Primary outcome: comparison of physical functioning score on SF36
Timeframe: enrolment, 6 weeks, 3,6 12 months
Trial details
NCT IDNCT00336752
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. Associated neurovascular injury or deficit in the affected limb
✕. Systemic diseases including diabetes, multiple sclerosis, Parkinson's disease, and other disorders which might affect peripheral sensorimotor function -