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NCT05625516
Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
trial testing Bilateral external torque device in Syndesmotic Injuries in 20 participants. Completed in 26 May 2025.
26 May 2025
Quick facts
| Lead sponsor | Balgrist University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 31 August 2023 |
| Primary completion | 26 May 2025 |
| Estimated completion | 26 May 2025 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Bilateral external torque device
Conditions studied
- Syndesmotic Injuries — all drugs for Syndesmotic Injuries →
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.
Verify or expand the search:
- PubMed search for NCT05625516
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Syndesmotic Injuries
Currently open trials in the same condition.
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Other Balgrist University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05625516 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Balgrist University Hospital
- Last refreshed: 19 June 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing