Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
- Conditions
- Acute Disruption of Ankle Syndesmosis
- Interventions
- Device: Suture Button vs Screw Fixation
- Registration Number
- NCT04972578
- Lead Sponsor
- University of Nebraska
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- Adults 19 years of age and older.
- Isolated rotational ankle injury
- Syndesmotic instability (determined either pre- or intra-operatively)
- Length-stable fibula fracture pattern
- 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 patient
- Baseline use of ambulatory assistive device prior to injury
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Screw Fixation Suture Button vs Screw Fixation Traditional fixation method of placing one or two screws across the syndesmosis. Suture Button Suture Button vs Screw Fixation Suture button implants which use a suture and anchor to repair the syndesmosis
- Primary Outcome Measures
Name Time Method Gait parameter - Stance time 1 year 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.
Gait parameter - Step width 1 Year 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.
Gait parameter - Swing time 1 year 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.
Gait parameter - Gait speed 1 year 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.
Gait parameter - Step length 1 year 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.
Gait parameter - Step time 1 year 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.
Gait parameter - Double support time 1 year 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.
- Secondary Outcome Measures
Name Time Method Development of radiographic arthritis 6 weeks, 3 months, 6 months, and 1 year Presence or absence of new radiographic tibiotalar arthritis will be noted on radiographs obtained at routine clinical follow-up visits.
Secondary procedures 1 year 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
Patient reported outcomes - Olerud-Molander Score 3 months, 6 months, and 1 year 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.
Implant complications 6 weeks, 3 months, 6 months, and 1 year 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).
Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity) 3 months, 6 months, and 1 year 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.
Time to fracture union 6 weeks, 3 months, 6 months, and 1 year Time to fracture union will be obtained based upon radiographic analysis at routine clinical follow-up visits.
Maintenance of syndesmotic reduction 6 weeks, 3 months, 6 months, and 1 year Maintenance or loss of syndesmotic reduction will be evaluated radiographically at routine clinical follow-up visits.
Postoperative wound complications 2 weeks, 6 weeks, 3 months, 6 months, and 1 year 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).
Ankle range of motion 2 weeks, 6 weeks, 3 months, 6 months, and 1 year 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).
Trial Locations
- Locations (3)
Lauritzen Outpatient Center
🇺🇸Omaha, Nebraska, United States
Village Point Outpatient Center
🇺🇸Omaha, Nebraska, United States
Nebraska Medicine, Bellevue Health Center
🇺🇸Bellevue, Nebraska, United States