Clinical trial NCT03970603: Syndesmosis Ankle Study
Official title: Weight-Bearing Timing and Outcomes After Surgical Suture Button Repair of the Distal Tibiofibular Syndesmosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Syndesmotic Disruption
Weight-bearing Status
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.

Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).

Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).

Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
3. Ability to ambulate preoperatively

Exclusion Criteria:

1. Younger than 18
2. Length unstable syndesmotic injury (i.e. Maisonneuve)
3. Neuropathic diabetics
4. 325 pounds or more
5. Prisoner
6. Pregnant or lactating
7. End stage renal disease
8. Inability to follow commands (dementia, TBI, etc.)
9. Polytrauma patients

Primary outcomes:
measure: Measure of the syndesmotic change
timeFrame: 1 year
Secondary outcomes:
measure: Pain scores
timeFrame: 2 weeks to 1 year
measure: Surgical Experience (SSQ-8)
timeFrame: Day 0
measure: Work productivity and activity impairment (WPAI)
timeFrame: 6 weeks to 1 year
measure: Foot and ankle outcomes (AAOS)
timeFrame: 2 weeks to 1 year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Vicki Jones
state: Missouri
Study officials:
affiliation: University of Missouri Health System, Department of Orthopaedic Surgery
name: Kyle Schweser, MD
role: PRINCIPAL_INVESTIGATOR
References: