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NCT05625516

Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency

Completed Last updated 19 June 2025
What this trial tests

trial testing Bilateral external torque device in Syndesmotic Injuries in 20 participants. Completed in 26 May 2025.

Timeline
31 August 2023
Primary endpoint
26 May 2025
26 May 2025

Quick facts

Lead sponsorBalgrist University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date31 August 2023
Primary completion26 May 2025
Estimated completion26 May 2025
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Balgrist University Hospital

Who can join

Adults 18 to 75, any sex, with Syndesmotic Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Syndesmotic Injuries

Currently open trials in the same condition.

Other Balgrist University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05625516.

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