Clinical trial NCT04972578: Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
Official title: Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Disruption of Ankle Syndesmosis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Adults 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 patient
* Baseline use of ambulatory assistive device prior to injury

Primary outcomes:
measure: Gait parameter - Step length
timeFrame: 3 months
measure: Gait parameter - Step length
timeFrame: 6 months
measure: Gait parameter - Step length
timeFrame: 1 year
measure: Gait parameter - Step width
timeFrame: 3 months
measure: Gait parameter - Step width
timeFrame: 6 months
measure: Gait parameter - Step width
timeFrame: 1 Year
measure: Gait parameter - Step time
timeFrame: 3 months
measure: Gait parameter - Step time
timeFrame: 6 months
measure: Gait parameter - Step time
timeFrame: 1 year
measure: Gait parameter - Swing time
timeFrame: 3 months
measure: Gait parameter - Swing time
timeFrame: 6 months
measure: Gait parameter - Swing time
timeFrame: 1 year
measure: Gait parameter - Stance time
timeFrame: 3 months
measure: Gait parameter - Stance time
timeFrame: 6 months
measure: Gait parameter - Stance time
timeFrame: 1 year
measure: Gait parameter - Double support time
timeFrame: 3 months
measure: Gait parameter - Double support time
timeFrame: 6 months
measure: Gait parameter - Double support time
timeFrame: 1 year
measure: Gait parameter - Gait speed
timeFrame: 3 months
measure: Gait parameter - Gait speed
timeFrame: 6 months
measure: Gait parameter - Gait speed
timeFrame: 1 year
Secondary outcomes:
measure: Time to fracture union
timeFrame: 6 weeks, 3 months, 6 months, and 1 year
measure: Maintenance of syndesmotic reduction
timeFrame: 6 weeks, 3 months, 6 months, and 1 year
measure: Development of radiographic arthritis
timeFrame: 6 weeks, 3 months, 6 months, and 1 year
measure: Implant complications
timeFrame: 6 weeks, 3 months, 6 months, and 1 year
measure: Secondary procedures
timeFrame: 1 year
measure: Postoperative wound complications
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
measure: Ankle range of motion
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
measure: Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity)
timeFrame: 3 months, 6 months, and 1 year
measure: Patient reported outcomes - Olerud-Molander Score
timeFrame: 3 months, 6 months, and 1 year
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Nebraska Medicine, Bellevue Health Center
state: Nebraska
city: Omaha
country: United States
facility: Lauritzen Outpatient Center
state: Nebraska
city: Omaha
country: United States
facility: Village Point Outpatient Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Sarah M Putnam, MD
role: PRINCIPAL_INVESTIGATOR
References: