Acute Disruption of Ankle Syndesmosis
Conditions
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
Interventions
DEVICESuture Button vs Screw Fixation
Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait parameter - Step length | 3 months | 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 width | 3 months | 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 - Step time | 3 months | 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 - Swing time | 3 months | 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 - Stance time | 3 months | 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 - Double support time | 3 months | 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. |
| Gait parameter - Gait speed | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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). |
| 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 |
| 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). |
Countries
United States
Outcome results
None listed