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Syndesmosis Ankle Study

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ClinicalTrials.gov Identifier: NCT03970603
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kyle Schweser MD, University of Missouri-Columbia

Brief 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 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).


Condition or disease Intervention/treatment Phase
Syndesmotic Disruption Weight-bearing Status Other: Early Weight-Bearing Other: Delayed/Late Weight-Bearing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight-Bearing Timing and Outcomes After Surgical Suture Button Repair of the Distal Tibiofibular Syndesmosis
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Early Weight-Bearing
Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption
Other: Early Weight-Bearing
Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption

Active Comparator: Delayed/Late Weight-Bearing
Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption
Other: Delayed/Late Weight-Bearing
Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 2 weeks to 1 year ]
    Measured on a 0-10 scale by VAS or PROMIS patient reported outcome forms

  2. Surgical Experience (SSQ-8) [ Time Frame: Day 0 ]
    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.

  3. Work productivity and activity impairment (WPAI) [ Time Frame: 6 weeks to 1 year ]
    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.

  4. Foot and ankle outcomes (AAOS) [ Time Frame: 2 weeks to 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
  3. Ability to ambulate preoperatively

Exclusion Criteria:

  1. Younger than 18
  2. Length unstable syndesmotic injury (i.e. Maisonneuve)
  3. Neuropathic diabetics
  4. 325 pounds or more
  5. Prisoner
  6. Pregnant or lactating
  7. End stage renal disease
  8. Inability to follow commands (dementia, TBI, etc.)
  9. Polytrauma patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970603


Contacts
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Contact: Stacee Clawson, BSN, RN 5738849017 clawsons@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65212
Contact: Susan Kady, BSN, RN         
Sponsors and Collaborators
Kyle Schweser MD
Investigators
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Principal Investigator: Kyle Schweser, MD University of Missouri Health System, Department of Orthopaedic Surgery
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Responsible Party: Kyle Schweser MD, Orthopaedic Trauma Surgeon, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03970603    
Other Study ID Numbers: 2014428
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No