A new diagnostic tool for detecting syndesmotic injuries
Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
This study is testing a new tool to see if it can help doctors better detect syndesmotic injuries in patients with ankle problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT05625516 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a novel diagnostic tool, the bilateral external torque device, for detecting syndesmotic insufficiency in patients with acute and chronic syndesmosis injuries. The study will involve applying controlled external torque to the ankle while monitoring pain tolerance and fibula translation, with comparisons made to traditional stress fluoroscopy methods. The goal is to improve early diagnosis and treatment of syndesmotic injuries, which can lead to chronic pain and complications if missed.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with proven acute or chronic syndesmosis injuries confirmed by MRI.
Not a fit: Patients with previous surgeries on the affected ankle or severe deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could lead to more accurate diagnoses and better treatment outcomes for patients with syndesmotic injuries.
How similar studies have performed: Previous studies have shown that this approach can reliably detect syndesmosis instabilities, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Zürich
- Balgrist University Hospital — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stephan Wirth, PD — Universitätsklinik Balgrist
- Study coordinator: Silvan Beeler, PD
- Email: silvan.beeler@balgrist.ch
- Phone: +41443861111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.