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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• Adults 19 years of age and older.

• Isolated rotational ankle injury

• Syndesmotic instability (determined either pre- or intra-operatively)

• Length-stable fibula fracture pattern

Locations
United States
Nebraska
Nebraska Medicine, Bellevue Health Center
RECRUITING
Bellevue
Lauritzen Outpatient Center
RECRUITING
Omaha
Village Point Outpatient Center
RECRUITING
Omaha
Contact Information
Primary
Sarah M Putnam, MD
sara.putnam@unmc.edu
402-559-8519
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 78
Treatments
Active_comparator: Screw Fixation
Traditional fixation method of placing one or two screws across the syndesmosis.
Active_comparator: Suture Button
Suture button implants which use a suture and anchor to repair the syndesmosis
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov