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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Maimonides Medical Center · with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · NCT06085586

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
56
US sites recruiting
1
Study start
July 13, 2023
Record last updated
March 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Early Weight Bearing; Normal Weight Bearing

Conditions: Ankle Fractures; Bimalleolar Fractures; Syndesmotic Injuries; Bimalleolar Equivalent Fracture; Maisonneuve Fracture; Trimalleolar Fractures; Ankle Dislocation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Maimonides Medical Center

    Brooklyn, NY 11219

    Site contact: Antonios Likourezos · 718-283-6896 · alikourezos@maimonidesmed.org

Study contacts (from the official record)

  • Amr A Abdelgawad, MD PhD MBA · 7182837400 · aabdelgawad@maimonidesmed.org
  • Ariel N Rodriguez, MD · 7182837400 · arrodriguez@maimonidesmed.org
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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing (NCT06085586) | Bored Studies