Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Not Applicable

Recruiting

• Conditions: Ankle Dislocation; Bimalleolar Fractures; Syndesmotic Injuries; Bimalleolar Equivalent Fracture; Ankle Fractures; Trimalleolar Fractures; Maisonneuve Fracture
• Interventions: Other: Early Weight Bearing; Other: Normal Weight Bearing

• Registration Number: NCT06085586
• Lead Sponsor: Maimonides Medical Center

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.

Study Timeline

• Study Start: 2023-07-13
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1) Early Full Weight Bearing	Early Weight Bearing	Full weight bearing (100%) initiated at 4 weeks postoperatively
2) Normal Full Weight Bearing	Normal Weight Bearing	Full weight bearing (100%) initiated at 6 weeks postoperatively

Primary Outcome Measures

Name	Time	Method
6 Month Reduction Quality	6 Months	The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.

Secondary Outcome Measures

Name	Time	Method
8-10 Week Reduction Quality	8-10 Weeks	Reduction and maintenance of the reduction of the ankle syndesmosis at 8-10 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
4-6 Week Reduction Quality	4-6 Weeks	Reduction and maintenance of the reduction of the ankle syndesmosis at 4-6 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
3 Month Reduction Quality	3 Months	Reduction and maintenance of the reduction of the ankle syndesmosis at 3 months based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
OR Time	1 Day	Operating Room Time in Minutes
Postoperative Complications	30 Days	Any complications that occurred postoperatively within 30 Days
2 Week Reduction Quality	2 Weeks	Reduction and maintenance of the reduction of the ankle syndesmosis at 2 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
Surgical Approach/Procedure Type	1 Day	Surgical Approach/Procedure Type
Intraoperative Complications	1 Day	Any complications that occurred intraoperatively
Reoperation or Revision	6 Months	Unplanned Reoperation or late-stage revision
Type of Additional Fixation	1 Day	Type of Additional Fixation

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States