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Syndesmosis Ankle Study

NCT ID: NCT03970603

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2025-09-25

Brief Summary

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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).

Detailed Description

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Conditions

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Syndesmotic Disruption Weight-bearing Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early Weight-Bearing

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

Group Type ACTIVE_COMPARATOR

Early Weight-Bearing

Intervention Type OTHER

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

Delayed/Late Weight-Bearing

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

Group Type ACTIVE_COMPARATOR

Delayed/Late Weight-Bearing

Intervention Type OTHER

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

Interventions

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Early Weight-Bearing

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

Intervention Type OTHER

Delayed/Late Weight-Bearing

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyle Schweser MD

OTHER

Sponsor Role lead

Responsible Party

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Kyle Schweser MD

Orthopaedic Trauma Surgeon, Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kyle Schweser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Health System, Department of Orthopaedic Surgery

Locations

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Vicki Jones

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2014428

Identifier Type: -

Identifier Source: org_study_id