Early Weight-Bearing Device for Ankle Injury
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Fibulink Syndesmosis Repair System for ankle injuries?
Research on similar treatments, like the TightRope™ system, shows that they can effectively stabilize ankle injuries and allow for a quicker recovery compared to traditional screw methods. This suggests that the Fibulink Syndesmosis Repair System might also be effective in treating ankle injuries.12345
What makes the Fibulink Syndesmosis Repair System treatment unique for ankle injuries?
The Fibulink Syndesmosis Repair System is unique because it allows for early weight-bearing after an ankle injury without the need for partial device removal, unlike many traditional methods. This system uses flexible, synthetic materials to stabilize the ankle, promoting faster recovery and reducing the need for additional surgeries.13678
Research Team
Amr A Abdelgawad, MD PhD MBA
Principal Investigator
Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
Eligibility Criteria
This trial is for individuals with certain types of ankle injuries, including fractures and dislocations that involve the syndesmosis joint. Candidates must not have had previous ankle surgery, open fractures, or conditions like diabetes neuropathy that could affect healing. Pregnant individuals or those unable to consent are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Surgical fixation of fractures and syndesmosis, followed by initial recovery in a short leg cast
Early Postoperative Phase
Transition to CAM boot, initiation of early active ankle range-of-motion, and suture removal
Weight Bearing and Physical Therapy
Initiation of full weight bearing with CAM boot at 4 or 6 weeks, followed by physical therapy
Follow-up
Participants are monitored for reduction quality and complications at 3 and 6 months
Treatment Details
Interventions
- Fibulink Syndesmosis Repair System
Fibulink Syndesmosis Repair System is already approved in United States for the following indications:
- Syndesmotic trauma
- Weber B and C ankle fractures
- Bimalleolar ankle fractures with syndesmotic injuries
- Maisonneuve fractures
- Trimalleolar ankle fractures without the need for posterior malleolus fixation
- Ankle fracture dislocations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maimonides Medical Center
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry Sponsor
Joaquin Duato
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. John Reed
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chief Medical Officer since 2023
MD from the University of Pennsylvania School of Medicine