Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button

NCT ID: NCT04972578

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2026-01-09

Brief Summary

Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.

Detailed Description

This will be a prospective randomized study. Patients with isolated rotational ankle injuries with syndesmotic instability will be randomized to either screw fixation or suture fixation for treatment of their syndesmotic injury. Patients will be followed postoperatively for one year following surgery with documentation of both clinical outcomes and subjective patient reported outcomes. Additionally, postoperative gait patterns will be measured and compared between patients who had syndesmotic injuries treated with screw fixation versus suture fixation

Conditions

Acute Disruption of Ankle Syndesmosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Screw Fixation

Traditional fixation method of placing one or two screws across the syndesmosis.

Group Type: ACTIVE_COMPARATOR

Suture Button vs Screw Fixation

Intervention Type: DEVICE

Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)

Suture Button

Suture button implants which use a suture and anchor to repair the syndesmosis

Group Type: ACTIVE_COMPARATOR

Suture Button vs Screw Fixation

Intervention Type: DEVICE

Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)

Interventions

Suture Button vs Screw Fixation

Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 19 years of age and older
• Isolated rotational ankle injury
• Syndesmotic instability (determined either pre- or intra-operatively)
• Length-stable fibula fracture pattern

Exclusion Criteria

• Open fracture
• Length-unstable fracture pattern (including Maisonneuve fracture pattern)
• Syndesmotic stability (determined either pre- or intra-operatively)
• Lower extremity neuropathy
• History of prior trauma or surgery to injured ankle
• Non-ambulatory
• Use of ambulatory assistive device prior to injury

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah M Putnam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine, Bellevue Health Center

Bellevue, Nebraska, United States

Lauritzen Outpatient Center

Omaha, Nebraska, United States

Village Point Outpatient Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0146-21-FB

Identifier Type: -

Identifier Source: org_study_id