An interventional study of Early Weight Bearing and Normal Weight Bearing in Ankle Fractures, Bimalleolar Fractures and Syndesmotic Injuries, sponsored by Maimonides Medical Center. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Maimonides Medical Center · Not applicable, Interventional, and Treatment
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.
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.
This includes the following injuries:
Exclusion Criteria:
Full weight bearing (100%) initiated at 4 weeks postoperatively
Other: Early Weight Bearing
Full weight bearing (100%) initiated at 6 weeks postoperatively
Other: Normal Weight Bearing
Full weight bearing (100%) initiated at 4 weeks postoperatively
Full weight bearing (100%) initiated at 6 weeks postoperatively
6 Month Reduction Quality
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.
Time frame: 6 Months
2 Week Reduction Quality
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.
Time frame: 2 Weeks
4-6 Week Reduction Quality
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.
Time frame: 4-6 Weeks
8-10 Week Reduction Quality
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.
Time frame: 8-10 Weeks
3 Month Reduction Quality
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.
Time frame: 3 Months
Reoperation or Revision
Unplanned Reoperation or late-stage revision
Time frame: 6 Months
OR Time
Operating Room Time in Minutes
Time frame: 1 Day
Surgical Approach/Procedure Type
Surgical Approach/Procedure Type
Time frame: 1 Day
Type of Additional Fixation
Type of Additional Fixation
Time frame: 1 Day
Intraoperative Complications
Any complications that occurred intraoperatively
Time frame: 1 Day
Postoperative Complications
Any complications that occurred postoperatively within 30 Days
Time frame: 30 Days
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maimonides Medical Center