What is the Fibulink Syndesmosis Repair System studying for ankle fractures?

The study is evaluating how well the Fibulink system maintains ankle alignment after fractures with syndesmotic injury. Researchers want to see if starting full weight bearing earlier improves recovery. The trial is sponsored by Maimonides Medical Center and aims to improve treatment options for these injuries.

Who may be eligible for this ankle fracture clinical trial?

Adults aged 22 years and older with certain types of ankle fractures involving syndesmotic disruption may be eligible. The study includes both males and females. Important factors include not having previous ankle surgery, no active infections, and no chronic ankle deformities. Please review eligibility criteria for more details.

Is there any cost to participate in this ankle fracture clinical trial?

Study-related care, including surgery and all trial visits, is provided at no cost. However, personal travel or other expenses related to participating may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

Healthy Volunteers

ID06085586

Study of the Fibulink Syndesmosis Repair System for Ankle Fractures with Early Full Weight Bearing

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

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the Fibulink Syndesmosis Repair Systems 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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Early Weight Bearing at 4 Weeks	Normal Weight Bearing at 6 Weeks
What it is	Full weight bearing at 4 weeks after surgery, using the fibulink syndesmosis repair system for ankle fractures with syndesmotic injury.	Full weight bearing at 6 weeks after fibulink syndesmosis repair for ankle fractures with syndesmotic injury.
Role in trial	Investigational arm testing whether earlier weight bearing improves reduction quality and may reduce immobilization time.	Comparator arm reflecting traditional timing, evaluating if later weight bearing maintains reduction quality and outcomes.
Primary use	Allows patients to put full weight on the operated ankle at 4 weeks, aiming for earlier rehabilitation after syndesmotic repair.	Delays full weight bearing until 6 weeks after surgery, following established practice for post-syndesmotic repair recovery.
How it is given or performed	Patients begin putting 100% weight through the repaired ankle starting at 4 weeks after surgery. Postoperative monitoring follows trial protocol.	Patients start full weight bearing on the repaired ankle at 6 weeks after surgery, consistent with established recovery protocol.
Evidence status	Trial is ongoing—clinical outcomes for early weight bearing are not yet established. Earlier weight bearing after syndesmosis repair is supported by prior evidence using suture-button constructs but remains under study for the fibulink system.	Conventional timing for weight bearing supported as standard practice; published reviews and comparative studies support delayed weight bearing for healing and reduction maintenance after syndesmosis repair.
Important limitations	Safety and efficacy for earlier full weight bearing with fibulink repair are not yet fully established. Prior positive evidence is limited to similar suture-button devices; applicability to fibulink requires verification.	Delayed weight bearing prolongs immobilization, which may hinder rehabilitation speed. Rigid adherence may not be necessary for all patients, and individualized protocols are increasingly discussed in literature.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 22Years +

All Genders

Healthy Volunteers

Eligibility Criteria

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

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

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