Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
Healthy Volunteers
ID06085586

Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Led by Maimonides Medical Center · Updated on 2026-03-20

56

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Maimonides Medical Center

Lead Sponsor

J

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the Fibulink Syndesmosis Repair System's ability to maintain proper alignment of the ankle syndesmosis after injury. Proper reduction is essential to avoid chronic instability, joint damage, and arthritis. The study focuses on patients with ankle fractures involving syndesmotic disruption, comparing early versus normal timing to begin full weight bearing after surgery. Participants will undergo surgical fixation of their ankle fractures, including the Fibulink system for syndesmotic repair if instability is detected during surgery. Two groups are studied: one begins full weight bearing with a Controlled Ankle Motion (CAM) boot at 4 weeks post-operation, and the other at 6 weeks. Postoperative care includes short leg casting initially, followed by CAM boot use and physical therapy. Participants will be followed and assessed at 2 weeks, 4-6 weeks, 8-10 weeks, 3 months, and 6 months after surgery. At each visit, imaging will measure the quality of ankle alignment and joint space. Researchers will also track surgical details, complications, and any need for reoperation. The main outcome is the ankle reduction quality at 6 months, with additional timepoint assessments and safety monitoring throughout the study.

CONDITIONS

Brief Title

Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Who Can Participate

Age: 22Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ankle fracture with syndesmotic disruption confirmed by intra-operative cotton test
  • Includes syndesmotic sprain without fractures
  • Includes bimalleolar equivalent ankle fractures
  • Includes bimalleolar ankle fractures
  • Includes Maisonneuve fractures
  • Includes trimalleolar ankle fractures without posterior malleolus fixation
  • Includes ankle fracture dislocations
Not Eligible

You will not qualify if you...

  • Previous ankle surgery
  • Active local infection about the ankle
  • Chronic ankle deformity from trauma or congenital causes
  • Ligamentous laxity
  • Pathologic fractures
  • Peripheral vascular disease
  • Peripheral neuropathy
  • Diabetes neuropathy and Charcot arthropathy
  • Open fractures
  • Polytrauma
  • Inability to provide informed consent
  • Symptomatic ankle osteoarthritis
  • Retained hardware
  • Pregnancy
  • Metabolic bone disease
  • History of chronic steroid use
  • Mal-reduced ankle fractures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks

Participants undergo surgery to fix ankle fractures and, if needed, syndesmotic fixation using the Fibulink Syndesmosis Repair System. Postoperative care includes placement in a short leg cast.

1 surgical procedure and 1 post-operative visit at 2 weeks

Post-operative Follow-up

Duration - Up to 10 weeks

Participants follow a recovery plan with cast removal, suture removal, and transition to a CAM boot with early ankle motion. Full weight bearing is initiated at 4 or 6 weeks depending on the study group, followed by physical therapy and gradual removal of the CAM boot.

Visits at 2 weeks, 4-6 weeks, and 8-10 weeks postoperatively

Follow-up

Duration - Up to 6 months

Participants continue follow-up assessments to monitor recovery and reduction quality at 3 and 6 months after surgery.

Visits at 3 months and 6 months postoperatively

Trial Site Locations

Total: 1 location

1

Maimonides Medical Center

Brooklyn, New York, United States, 11219

Actively Recruiting

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Research Team

A

Amr A Abdelgawad, MD PhD MBA

A

Ariel N Rodriguez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The Effect of Varying Tension of a Suture Button Construct in Fixation of the Tibiofibular Syndesmosis-Evaluation Using Stress Computed Tomography.

John Morellato, Hakim Louati, Andrew Bodrogi...

https://pubmed.ncbi.nlm.nih.gov/28129269

Transosseous fixation of the distal tibiofibular syndesmosis: comparison of an interosseous suture and endobutton to traditional screw fixation in 50 cases.

James M Cottom, Christopher F Hyer, Terrence M Philbin...

https://pubmed.ncbi.nlm.nih.gov/19857816

Ankle syndesmosis repair and rehabilitation in professional rugby league players: a case series report.

Alex James Latham, Peter Charles Goodwin, Ben Stirling...

https://pubmed.ncbi.nlm.nih.gov/28761696