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

NCT05625516 | Completed DMC

• 1 other identifier: 2022-D0111
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• External torque CT

  = the applied torque measurement in Newton meters (maximum up to 7.5 Nm) up to the pain tolerance limit. In the chronic injuries, at least 5 Nm should be achieved. If this is not possible due to pain, patients with chronic injuries are infiltrated intra-articularly into the upper ankle joint with 5ml ropivacaine 2% under sterile conditions.

  24 months

Study Arms (3)

Patients with acute syndesmotic injuries

The patients undergo a bilateral external torque CT.

Device: Bilateral external torque device

Patients with asymptomatic chronic syndesmotic injuries

The patients undergo a bilateral external torque CT.

Device: Bilateral external torque device

Patients with symptomatic chronic syndesmotic injuries

The patients undergo a bilateral external torque CT.

Device: Bilateral external torque device

Interventions

Bilateral external torque device 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.

Patients with acute syndesmotic injuries; Patients with asymptomatic chronic syndesmotic injuries; Patients with symptomatic chronic syndesmotic injuries

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 patients with acute syndesmotic injuries 10 patients with symptomatic chronic syndesmotic injuries 10 patients with aysmptomatic chronic syndesmotic injuries

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Stephan Wirth, PD

  Universitätsklinik Balgrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: August 31, 2023
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CH (1)