Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency (NCT05625516) | Clinical Trial Compass
CompletedNot Applicable
Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
Switzerland20 participantsStarted 2023-08-31
Plain-language summary
Study population: the investigator set them sample size to 30 patients.
Primary endpoint (concerning both study questions): is the applied torque measurement in Newton meters (maximum up to 7.5 Nm) up to the pain tolerance limit. For the chronic injuries, a minimum of 5 Nm should be achieved. If this is not possible due to pain, an intra-articular infiltration into the upper ankle joint with 5ml Ropivacaine 2% is performed under sterile conditions.
In addition, fibula translation while exercising the maximum tolerated External Torque CT (maximum up to 7.5 Nm).
Secondary endpoint (1st study question): the comparison to stress fluoroscopy without anesthesia and under anesthesia.
Secondary endpoint (2nd study question): the comparison of patients with and without symptoms. Secondary endpoint in patients who received intra-articular infiltration is the increase in tolerated Newton meters.
Who can participate
Age range
18 Years – 75 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:
* Written informed consent
* Patient age of ≥18 yr and ≤75 yr.
* Proven acute (\<4 weeks) syndesmosis injury (anterior and posterior) on MRI.
* Proven chronic (\>2 months) syndesmosis injury (anterior and posterior) on MRI with/without surgical stabilization performed.
* Healthy opposite side
Exclusion Criteria:
* A dependency between patient sponsor and/or project management
* Pregnancy (contraindication for CT): in women of childbearing age, a pregnancy test is performed in any case
* St.n. previous operation(s) of the affected lower extremity (specifically of the ankle joint).
* Severe deformities (osteoarthritis with limited function upper and lower ankle joint, metatarsophalangeal joint).
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.