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

NCT05625516 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Syndesmotic Injuries

Interventions

DEVICE

Bilateral external torque device

The "External Torque Device" was developed, which allows bilateral stressing of the syndesmosis by external rotation. Both lower legs are stabilized by a special knee brace (the fibula remains free to float) or by the hip joints, which are end rotated on both sides, while an external rotation force of maximum 7.5Nm (or up to the respective pain threshold) can be set on both sides using torque newton meters. If no load is possible - which the examination of the syndesmosis generally does not allow - an intra-articular local anesthesia with 5ml ropivacaine 2mg/ml can be performed under sterile conditions after the patient's consent.

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Stephan Wirth, PD · Universitätsklinik Balgrist

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-05-26
Completion
2025-05-26

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05625516 on ClinicalTrials.gov