Syndesmotic DisruptionNCT03970603
Syndesmosis Ankle Study
A study testing Early Weight-Bearing and Delayed/Late Weight-Bearing in people with Syndesmotic Disruption and Weight-bearing Status, run by Kyle Schweser MD at 1 site in United States.
Trial summary
A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syndesmotic Disruption, Weight-bearing Status
- What is being tested?
- Early Weight-Bearing and Delayed/Late Weight-Bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 25 Sep 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
- Ability to ambulate preoperatively
Who cannot join
- Younger than 18
- Length unstable syndesmotic injury (i.e. Maisonneuve)
- Neuropathic diabetics
- 325 pounds or more
- Prisoner
- Pregnant or lactating
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- End stage renal disease
- Inability to follow commands (dementia, TBI, etc.)
- Polytrauma patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight-Bearing Timing and Outcomes After Surgical Suture Button Repair of the Distal Tibiofibular Syndesmosis
A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.
Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).
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Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).
Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).
- Conditions
- Syndesmotic Disruption, Weight-bearing Status
- Being tested
- Early Weight-Bearing, Delayed/Late Weight-Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Weight-BearingOther
Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption
Delayed/Late Weight-BearingOther
Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption
| Study group | Role | What they receive |
|---|---|---|
| Early Weight-Bearing | Active comparator | Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption Receives: Other: Early Weight-Bearing |
| Delayed/Late Weight-Bearing | Active comparator | Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption Receives: Other: Delayed/Late Weight-Bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the syndesmotic change
Determined by comparing the 1-year, post-operative CT scan to the immediate post-operative CT scan of the injured ankle
Measured: 1 year
Secondary outcomes (4)
Pain scores
Measured on a 0-10 scale by VAS or PROMIS patient reported outcome forms
Measured: 2 weeks to 1 year
Surgical Experience (SSQ-8)
The SSQ-8 (Surgical Satisfaction Score) is a patient administered 8-item survey designed to asses satisfaction after a surgical procedure. Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.
Measured: Day 0
Work productivity and activity impairment (WPAI)
The Work Productivity and Activity Impairment (WPAI) questionnaire is a self-administered instrument used to assess the impact of disease on productivity. The sum of specific health problem impairment and impairment due to other health reasons is equal to impairment due to all health reasons. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Measured: 6 weeks to 1 year
Foot and ankle outcomes (AAOS)
The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed amongst five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with1 being the best outcome score.
Measured: 2 weeks to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Oct 2019
- Primary completion26 Oct 2023
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic DisruptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyle Schweser MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyle Schweser MD, University of Missouri-Columbia
- Investigators
- Kyle Schweser, MD, Principal investigator, University of Missouri Health System, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970603
- Sponsor's protocol ID
- 2014428
- Status last verified
- Nov 2025
- First submitted
- 28 May 2019
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-Bearing Timing and Outcomes After Surgical Suture Button Repair of the Distal Tibiofibular Syndesmosis
- ClinicalTrials.gov ID
- NCT03970603
- Acronym / sponsor ID
- 2014428
- Conditions
- Syndesmotic Disruption, Weight-bearing Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kyle Schweser MDUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 31 May 2019 (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.
A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.
Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).
Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).
Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weight-Bearing | Active comparator | Other: Early Weight-BearingBeing directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption |
| Delayed/Late Weight-Bearing | Active comparator | Other: Delayed/Late Weight-BearingBeing directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
- Ability to ambulate preoperatively
Key exclusion criteria (9 listed)
- Younger than 18
- Length unstable syndesmotic injury (i.e. Maisonneuve)
- Neuropathic diabetics
- 325 pounds or more
- Prisoner
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 |
|---|---|---|
| Early Weight-BearingBeing directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption | Other | Early Weight-Bearing |
| Delayed/Late Weight-BearingBeing directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption | Other | Delayed/Late Weight-Bearing |
Primary outcome
Measure of the syndesmotic change
Time frame: 1 year
Determined by comparing the 1-year, post-operative CT scan to the immediate post-operative CT scan of the injured ankle
4 secondary outcomes
Pain scores
Time frame: 2 weeks to 1 year
Surgical Experience (SSQ-8)
Time frame: Day 0
Work productivity and activity impairment (WPAI)
Time frame: 6 weeks to 1 year
Foot and ankle outcomes (AAOS)
Time frame: 2 weeks to 1 year
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 12 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Syndesmotic Disruption
Active, not recruiting
Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption
Unstable Ankle Fractures With Syndesmotic Disruption
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.
Kyle Schweser, MD principal investigator
University of Missouri Health System, Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Weight-Bearing and Delayed/Late Weight-Bearing in people with Syndesmotic Disruption and Weight-bearing Status, run by Kyle Schweser MD at 1 site in United States.
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 3 inclusion and 9 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 12 Nov 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 United States. 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?
Measure of the syndesmotic change (time frame: 1 year). 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 12 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.