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

University of Nebraska

Status: Terminated

Conditions: Acute Disruption of Ankle Syndesmosis

Treatments: Device: Suture Button vs Screw Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04972578

0146-21-FB

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Screw Fixation

Active Comparator group

Description:

Traditional fixation method of placing one or two screws across the syndesmosis.

Treatment:

Device: Suture Button vs Screw Fixation

Suture Button

Active Comparator group

Description:

Suture button implants which use a suture and anchor to repair the syndesmosis

Treatment:

Device: Suture Button vs Screw Fixation