Syndesmosis Ankle Study

NCT03970603 | Completed

• 1 other identifier: 2014428
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Syndesmotic Disruption; Weight-bearing Status

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (4)

• Pain scores

  2 weeks to 1 year

• Surgical Experience (SSQ-8)

  Day 0

• Work productivity and activity impairment (WPAI)

  6 weeks to 1 year

• Foot and ankle outcomes (AAOS)

  2 weeks to 1 year

Study Arms (2)

Early Weight-Bearing

ACTIVE COMPARATOR

Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption

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

Other: Delayed/Late Weight-Bearing

Interventions

Early Weight-Bearing OTHER

Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption

Early Weight-Bearing

Delayed/Late Weight-Bearing OTHER

Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption

Delayed/Late Weight-Bearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Younger than 18
• Length unstable syndesmotic injury (i.e. Maisonneuve)
• Neuropathic diabetics
• pounds or more
• Prisoner
• Pregnant or lactating
• End stage renal disease
• Inability to follow commands (dementia, TBI, etc.)
• Polytrauma patients

Sponsors & Collaborators

• Kyle Schweser MD: lead

Study Sites (1)

Vicki Jones

Columbia, Missouri, 65212, United States

Location

Study Officials

• Kyle Schweser, MD

  University of Missouri Health System, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopaedic Trauma Surgeon, Assistant Professor

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: October 15, 2019
• Primary Completion: October 26, 2023
• Study Completion: September 25, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)