Recruiting

Fibulink

Sponsor:

Maimonides Medical Center

Code:

NCT06085586

Conditions

Ankle Fractures

Bimalleolar Fractures

Syndesmotic Injuries

Bimalleolar Equivalent Fracture

Maisonneuve Fracture

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Early Weight Bearing

Normal Weight Bearing

Study Details

Brief summary:

The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.

Conditions

Ankle Fractures

Bimalleolar Fractures

Syndesmotic Injuries

Bimalleolar Equivalent Fracture

Maisonneuve Fracture

Study ID

NCT06085586

Start date

Jul 13, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.

This includes the following injuries:

  • Syndesmotic sprain (without fractures)
  • Bimalleolar equivalent ankle fractures
  • Bimalleolar ankle fractures
  • Maisonneuve fractures
  • Trimalleolar ankle fractures without the need for posterior malleolus fixation
  • Ankle fracture dislocations

Exclusion Criteria:

  • 1\) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1) Early Full Weight Bearing

Full weight bearing (100%) initiated at 4 weeks postoperatively

active comparator: 2) Normal Full Weight Bearing

Full weight bearing (100%) initiated at 6 weeks postoperatively

Interventions

Early Weight Bearing

Full weight bearing (100%) initiated at 4 weeks postoperatively

Normal Weight Bearing

Full weight bearing (100%) initiated at 6 weeks postoperatively

Primary outcome measure

  • 6 Month Reduction Quality [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Principal Investigator:

Amr A Abdelgawad, MD PhD MBA

More Information

Sponsor

Maimonides Medical Center

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Ankle Fractures
  • Bimalleolar Fractures
  • Bimalleolar Equivalent Fracture
  • Trimalleolar Fractures
  • Maisonneuve Fractures
  • Syndesmotic Injuries
  • Ankle Dislocations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maimonides Medical Center on 2026-03-20.