Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Latera… (NCT03587571) | Clinical Trial Compass
TerminatedPhase 4
Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures
Stopped: Insufficient patient recruitment
Switzerland3 participantsStarted 2018-05-01
Plain-language summary
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial.
The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
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:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Acute, stable lateral malleolar fracture
Definition of stable:
* Less than 2mm dislocation in a.p., lateral and gravity-stress x-ray
* Medial tibiotalar distance \<4mm and difference \<1mm compared to the superior clear space on the gravity-stress and weight bearing x-ray
* No talar subluxation
* No intraoperative instability (Hook-/Frick-Test)
* Between 18 and 65 years old
* Living in Switzerland
* Working
* Cognitive and physic ability to follow the study protocol
Exclusion Criteria:
* Instable fractures
* Previous ipsilateral surgery on the ankle or foot
* Pregnancy
* Diabetes mellitus
* Neurologic or vascular impairment
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
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.