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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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 -