56 Participants Needed

Early Weight-Bearing Device for Ankle Injury

AA
AN
Overseen ByAriel N Rodriguez, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Maimonides Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

AA

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

I have fractures in both bones of my ankle.
I have a dislocated ankle fracture.
I have a three-part ankle fracture that doesn't require surgery on the back part of my ankle.
See 4 more

Exclusion Criteria

You have multiple injuries from a serious accident.
I have a broken bone that is exposed through my skin.
I have diabetes-related nerve damage.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Initial Recovery

Surgical fixation of fractures and syndesmosis, followed by initial recovery in a short leg cast

2 weeks
1 visit (in-person)

Early Postoperative Phase

Transition to CAM boot, initiation of early active ankle range-of-motion, and suture removal

2-4 weeks
1 visit (in-person)

Weight Bearing and Physical Therapy

Initiation of full weight bearing with CAM boot at 4 or 6 weeks, followed by physical therapy

4-10 weeks
2 visits (in-person)

Follow-up

Participants are monitored for reduction quality and complications at 3 and 6 months

6 months
2 visits (in-person)

Treatment Details

Interventions

  • Fibulink Syndesmosis Repair System
Trial OverviewThe study tests the Fibulink Syndesmosis Repair System's effectiveness in maintaining proper alignment after an ankle injury. Participants will start full weight bearing with a CAM boot at 4 weeks post-surgery to see if it improves recovery compared to normal delayed weight bearing practices.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 1) Early Full Weight BearingExperimental Treatment1 Intervention
Full weight bearing (100%) initiated at 4 weeks postoperatively
Group II: 2) Normal Full Weight BearingActive Control1 Intervention
Full weight bearing (100%) initiated at 6 weeks postoperatively

Fibulink Syndesmosis Repair System is already approved in United States for the following indications:

🇺🇸
Approved in United States as FIBULINK Syndesmosis Repair System for:
  • 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

Trials
72
Recruited
15,400+

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry Sponsor

Trials
515
Recruited
845,000+
Joaquin Duato profile image

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 profile image

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

Findings from Research

The Endobutton plate cable system for treating distal tibiofibular syndesmosis injuries shows similar functional outcomes to traditional cortical screw fixation, with no significant differences in pain scores or healing rates after surgery.
While the Endobutton system resulted in a longer operative time and higher hospitalization costs, it allows for earlier functional exercises and eliminates the need for screw removal, making it a potentially advantageous option for patients.
[Endobutton and cortical screw fixation for the treatment of distal tibiofibular syndesmosis separated].Lou, YL., Hong, JJ., Shao, XW., et al.[2018]
In a study of 103 patients with high fibular fractures and syndesmosis injuries, the TightRope fixation device resulted in a significantly lower rate of malreduction (15%) compared to screw fixation (39%), indicating better stability with the TightRope method.
The reoperation rate was notably higher in the screw fixation group (30%) compared to the TightRope group (4%), suggesting that the TightRope device may lead to fewer complications and a more favorable outcome for patients.
Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study.Sanders, D., Schneider, P., Taylor, M., et al.[2023]
The novel double Endobutton fixation for treating distal tibiofibular syndesmotic injuries showed better stability compared to the intact syndesmosis and was more effective than traditional methods like screw fixation and Tightrope fixation in most tested conditions.
In biomechanical tests involving 24 ankle specimens, the double Endobutton fixation demonstrated slightly more micromotion than the Tightrope fixation, but it was still a viable option for improving outcomes in syndesmosis injuries.
Biomechanical comparison of screw, tightrope and novel double endobutton in the treatment of tibiofibular syndesmotic injuries.Zhang, L., Xiong, JX., Zhou, X., et al.[2022]

References

[Endobutton and cortical screw fixation for the treatment of distal tibiofibular syndesmosis separated]. [2018]
Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study. [2023]
Biomechanical comparison of screw, tightrope and novel double endobutton in the treatment of tibiofibular syndesmotic injuries. [2022]
Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study. [2021]
Effectiveness of the TightRope® Fixation in Treating Ankle Syndesmosis Injuries: A Critically Appraised Topic. [2021]
Repair of the tibiofibular syndesmosis with a flexible implant. [2022]
Syndesmotic ankle sprains in football: a survey of national football league athletic trainers. [2022]
[Development of a New Type Elastic Syndesmosis Hook Plate]. [2018]