Syndesmotic InjuriesNCT05625516
Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
An observational study of Syndesmotic Injuries, run by Balgrist University Hospital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Syndesmotic Injuries
- What is being tested?
- Bilateral external torque device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Aug 2023to 26 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients with acute syndesmotic injuries 10 patients with symptomatic chronic syndesmotic injuries 10 patients with aysmptomatic chronic syndesmotic injuries
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Isolated injuries to the distal tibiofibular syndesmosis affect approximately 1-17% of all ankle sprains and up to 30% in "high impact" sports. If the injury is missed, chronic syndesmosis instability can lead to prolonged convalescence, pain, and osteoarthritis of the upper ankle. Therefore, early diagnosis is essential for safe and effective treatment.
The diagnosis of syndesmosis insufficiency presents a certain dilemma in foot surgery. Already the differentiation between a simple fibular ligament lesion (low ankle sprain) and a syndesmosis injury (high ankle sprain) is often clinically difficult and only suggests a syndesmosis injury but does not confirm it.
The investigators have developed an external torque device that allows bilateral stressing of the syndesmosis by external rotation. In this case, both lower legs are stabilized by a special knee brace (fibula remains free floating) or by the hip joints, which are end rotated on both sides, while an external rotation force of maximum 7.5Nm (respectively up to the respective pain limit) can be set on both sides by means of torque newton meters. A CT can then be performed under external rotation stress.
In two previous studies (cadaver study and study on healthy subjects) the investigators have seen on the one hand that bilateral external torque CT is able to reliably detect syndesmosis instabilities and on the other hand that in healthy subjects the two ankle joints are comparable.
Based on these results the investigators want to address the following further questions:
- can "Bilateral External Torque CT" be reliably applied in patients with acute syndesmosis rupture?
- how stable does a syndesmosis have to be after an injury?
- Conditions
- Syndesmotic Injuries
- Being tested
- Bilateral external torque device
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral external torque deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute syndesmotic injuries | The patients undergo a bilateral external torque CT. Receives: Device: Bilateral external torque device | |
| Patients with asymptomatic chronic syndesmotic injuries | The patients undergo a bilateral external torque CT. Receives: Device: Bilateral external torque device | |
| Patients with symptomatic chronic syndesmotic injuries | The patients undergo a bilateral external torque CT. Receives: Device: Bilateral external torque device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start31 Aug 2023
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Wirth, PD, Principal investigator, Universitätsklinik Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625516
- Sponsor's protocol ID
- 2022-D0111
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
- ClinicalTrials.gov ID
- NCT05625516
- Acronym / sponsor ID
- 2022-D0111
- Conditions
- Syndesmotic Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Isolated injuries to the distal tibiofibular syndesmosis affect approximately 1-17% of all ankle sprains and up to 30% in "high impact" sports. If the injury is missed, chronic syndesmosis instability can lead to prolonged convalescence, pain, and osteoarthritis of the upper ankle. Therefore, early diagnosis is essential for safe and effective treatment.
The diagnosis of syndesmosis insufficiency presents a certain dilemma in foot surgery. Already the differentiation between a simple fibular ligament lesion (low ankle sprain) and a syndesmosis injury (high ankle sprain) is often clinically difficult and only suggests a syndesmosis injury but does not confirm it.
The investigators have developed an external torque device that allows bilateral stressing of the syndesmosis by external rotation. In this case, both lower legs are stabilized by a special knee brace (fibula remains free floating) or by the hip joints, which are end rotated on both sides, while an external rotation force of maximum 7.5Nm (respectively up to the respective pain limit) can be set on both sides by means of torque newton meters. A CT can then be performed under external rotation stress.
In two previous studies (cadaver study and study on healthy subjects) the investigators have seen on the one hand that bilateral external torque CT is able to reliably detect syndesmosis instabilities and on the other hand that in healthy subjects the two ankle joints are comparable.
Based on these results the investigators want to address the following further questions:
- can "Bilateral External Torque CT" be reliably applied in patients with acute syndesmosis rupture?
- how stable does a syndesmosis have to be after an injury?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with acute syndesmotic injuries | – | Device: Bilateral external torque deviceThe patients undergo a bilateral external torque CT. |
| Patients with asymptomatic chronic syndesmotic injuries | – | Device: Bilateral external torque deviceThe patients undergo a bilateral external torque CT. |
| Patients with symptomatic chronic syndesmotic injuries | – | Device: Bilateral external torque deviceThe patients undergo a bilateral external torque CT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with acute syndesmotic injuries 10 patients with symptomatic chronic syndesmotic injuries 10 patients with aysmptomatic chronic syndesmotic injuries
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral external torque deviceThe "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. | Device | Patients with acute syndesmotic injuries, Patients with asymptomatic chronic syndesmotic injuries, Patients with symptomatic chronic syndesmotic injuries |
Primary outcome
External torque CT
Time frame: 24 months
= 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Wirth, PD principal investigator
Universitätsklinik Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syndesmotic Injuries, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External torque CT (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.