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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Disruption of Ankle Syndesmosis
• Intervention / Treatment: Device: Suture Button vs Screw Fixation

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Nebraska Medicine, Bellevue Health Center
    • Omaha, Nebraska, United States, 68105
      • Lauritzen Outpatient Center
    • Omaha, Nebraska, United States, 68118
      • Village Point Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Screw Fixation; Traditional fixation method of placing one or two screws across the syndesmosis.	Device: Suture Button vs Screw Fixation; Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)
Active Comparator: Suture Button; Suture button implants which use a suture and anchor to repair the syndesmosis	Device: Suture Button vs Screw Fixation; Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait parameter - Step length	Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Step length	Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Step length	Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year
Gait parameter - Step width	Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Step width	Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Step width	Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 Year
Gait parameter - Step time	Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Step time	Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Step time	Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year
Gait parameter - Swing time	Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Swing time	Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Swing time	Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year
Gait parameter - Stance time	Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Stance time	Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Stance time	Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year
Gait parameter - Double support time	Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Double support time	Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Double support time	Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year
Gait parameter - Gait speed	Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	3 months
Gait parameter - Gait speed	Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	6 months
Gait parameter - Gait speed	Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to fracture union	Time to fracture union will be obtained based upon radiographic analysis at routine clinical follow-up visits.	6 weeks, 3 months, 6 months, and 1 year
Maintenance of syndesmotic reduction	Maintenance or loss of syndesmotic reduction will be evaluated radiographically at routine clinical follow-up visits.	6 weeks, 3 months, 6 months, and 1 year
Development of radiographic arthritis	Presence or absence of new radiographic tibiotalar arthritis will be noted on radiographs obtained at routine clinical follow-up visits.	6 weeks, 3 months, 6 months, and 1 year
Implant complications	Presence or absence of implant-related complications will be assessed radiographically at routine clinical follow-up visits (defined as screw fracture, loss of fixation, osteolysis surrounding implant).	6 weeks, 3 months, 6 months, and 1 year
Secondary procedures	The need for secondary procedures will be recorded. Secondary procedures would include of return trips to the OR for infection, for implant removal, for revision reduction or fixation, as well as in-office procedures including implant removal	1 year
Postoperative wound complications	Presence or absence of wound complications will be evaluated on physical exam at routine clinical follow-up visits (defined as superficial or deep infection, delayed wound healing, wound dehiscence).	2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Ankle range of motion	Ankle range of motion (tibiotalar dorsiflexion and plantarflexion) will be evaluated on physical exam at routine clinical follow-up visits (measured in degrees of dorsiflexion or plantarflexion from neutral).	2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity)	The PROMIS LE is a computer-adaptive test that reports a score of patient-perceived physical functioning (walking and mobility) specific to the lower extremity. Scores are reported as T scores, with a score of 50 equal to the mean of the general population. Higher scores indicate more favorable physical function. Theoretical maximum and minimum scores are 100 and 0, respectively.	3 months, 6 months, and 1 year
Patient reported outcomes - Olerud-Molander Score	The Olerud-Molander Score was designed to score patient-reported outcomes regarding symptoms after ankle fracture. Scale minimum and maximum are 0 and 100, respectively, with a higher score indicative of improved outcome.	3 months, 6 months, and 1 year

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Sarah M Putnam, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 8, 2026
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0146-21-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No