Clinical trial NCT06085586: Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Official title: Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Fractures
Bimalleolar Fractures
Syndesmotic Injuries
Bimalleolar Equivalent Fracture
Maisonneuve Fracture
Trimalleolar Fractures
Ankle Dislocation
Keywords: Ankle Fractures
Bimalleolar Fractures
Bimalleolar Equivalent Fracture
Trimalleolar Fractures
Maisonneuve Fractures
Syndesmotic Injuries
Ankle Dislocations
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2023-10-17
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle will be obtained. Manual or gravity stress view will be performed if needed. Treatment options including nonoperative and operative management will be discussed with the patient including the risks and benefits. An informed decision will be made. Two separate informed consent will be obtained. The first will be an informed consent for the surgery, detailing the planned surgical procedure. The second will be an informed consent for the enrollment of the study, detailing the purpose of the study and the use of the Fibulink Syndesmotic Repair System in any cases of syndesmotic injury.

Should the patient elects to proceed with surgery, the patient will be informed that fixation of the fractures will be performed first. Direct lateral approach to the distal fibular will be used for fixation of the lateral malleolus. If necessary, direct medial approach will be used for fixation of the medial malleolus. Once the fractures have been fixed, the syndesmosis will be stressed intraoperatively under live fluoroscopy. Based on the parameters described in 6.3, a decision will be made whether fixation of the syndesmosis is required if instability is noted. If fixation of the syndesmosis is required, it will be performed through the direct lateral approach.

The research coordinator will be informed of all patients that had the syndesmosis fixed with the Fibulink System. Patients will then be followed at the following time points: 2 weeks, 4-6 weeks, 8-10 weeks, 3 months and 6 months. During each follow-up time points, the tibiofibular overlap, tibiofibular clear space and medial clear space will be measured and recorded. The postoperative protocol will be as follow: Immediately post-op, patient will be placed in a short leg cast. At 2 weeks postop, the short leg cast will be removed. Suture removal will be performed. Patient will be placed in a CAM boot and instructed to perform early active ankle range-of-motion. Depending on the study group, at 4 weeks or 6 weeks postop, full weight bearing (100%) in the CAM boot will be allowed. Physical therapy will begin. At 8-10 weeks postop, full weight bearing (100%) without CAM boot will begin. Patients will continue to follow-up at 3 months and 6 months.

The research coordinator will ensure proper follow-up and will be responsible for data collection and input. After achieving the planned number of participants, the results of the two study sites will be gathered. Appropriate statistical analysis will be performed, and the results will be presented in a full manuscript format.

Eligibility 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

Primary outcomes:
measure: 6 Month Reduction Quality
timeFrame: 6 Months
Secondary outcomes:
measure: 2 Week Reduction Quality
timeFrame: 2 Weeks
measure: 4-6 Week Reduction Quality
timeFrame: 4-6 Weeks
measure: 8-10 Week Reduction Quality
timeFrame: 8-10 Weeks
measure: 3 Month Reduction Quality
timeFrame: 3 Months
measure: Reoperation or Revision
timeFrame: 6 Months
measure: OR Time
timeFrame: 1 Day
measure: Surgical Approach/Procedure Type
timeFrame: 1 Day
measure: Type of Additional Fixation
timeFrame: 1 Day
measure: Intraoperative Complications
timeFrame: 1 Day
measure: Postoperative Complications
timeFrame: 30 Days
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
name: Amr A Abdelgawad, MD PhD MBA
role: PRINCIPAL_INVESTIGATOR
References:
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