Early Weight-Bearing Device for Ankle Injury

Overseen By Ariel N Rodriguez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maimonides Medical Center

Disqualifiers: Previous ankle surgery, Diabetes, Peripheral neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Fibulink Syndesmosis Repair System to enhance healing in individuals with ankle injuries. The goal is to determine if starting full weight-bearing on the injured ankle at 4 weeks, instead of the usual 6 weeks, improves recovery. The trial involves two groups: one begins walking with full weight on the ankle at 4 weeks, and the other at 6 weeks after surgery. Participants with specific types of ankle fractures or sprains undergoing surgery are eligible.

As an unphased trial, participants can contribute to innovative research that may improve recovery times for future patients.

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 prior data suggests that the Fibulink Syndesmosis Repair System is safe for early weight-bearing in ankle injuries?

Research has shown that the Fibulink Syndesmosis Repair System is generally well-received by patients. In one study, patients who underwent this treatment reported good results, with an average score of 94 on a scale measuring foot and ankle health. This indicates that most participants did not experience major problems. Additionally, reports have documented successful surgeries without delays or complications. While every treatment carries some risks, the available data has not shown any major negative effects from the Fibulink system. This information may reassure those considering joining a trial about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Weight-Bearing Device for Ankle Injury trial because it explores a new approach to rehabilitation after ankle surgery. Unlike traditional protocols that typically delay full weight-bearing until six weeks post-surgery, this method tests the potential benefits of allowing patients to bear full weight just four weeks after surgery. The Fibulink Syndesmosis Repair System, used in this trial, aims to enhance recovery times and improve patient outcomes by potentially speeding up the rehabilitation process. This could lead to faster return to normal activities and a decrease in recovery-related complications, offering a promising improvement over the current standard care options.

What evidence suggests that the Fibulink Syndesmosis Repair System is effective for maintaining ankle syndesmosis reduction?

Research has shown that the Fibulink Syndesmosis Repair System stabilizes the ankle joint after an injury. Studies have found it holds the bones in place with less than 2 mm of movement, which is crucial because excessive movement can cause long-term joint issues. The system combines screws and flexible stitches to provide strong support while allowing some natural movement. In this trial, one group of participants will begin early full weight-bearing at 4 weeks postoperatively, while another group will start at 6 weeks. Early results suggest that this system might enable patients to bear full weight on their ankle sooner, potentially shortening recovery time. ^{1 2 5 6 7}

Who Is on the Research Team?

Amr A Abdelgawad, MD PhD MBA

Principal Investigator

Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Fibulink Syndesmosis Repair System

Trial Overview The 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.

How Is the Trial Designed?

Group I: 1) Early Full Weight Bearing Experimental Treatment 1 Intervention

Full weight bearing (100%) initiated at 4 weeks postoperatively

Group II: 2) Normal Full Weight Bearing Active Control 1 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

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

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. Jijo James, MD

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

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The flexible syndesmosis repair technique provides a reliable method for stabilizing ankle fractures with syndesmosis disruption, allowing patients to begin weight bearing as early as 6 weeks after surgery.

In a follow-up of 12 patients over 2-4 years, all fractures healed without deformity or instability, and the implanted devices remained intact, demonstrating the efficacy and safety of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of the tibiofibular syndesmosis with a flexible implant. Seitz, WH., Bachner, EJ., Abram, LJ., et al.[2022]

The TightRope™ fixation system for ankle syndesmosis injuries shows moderate evidence of effectiveness, providing similar outcomes to conventional screw fixation while allowing for a quicker recovery and return to activity.

Five studies, including randomized control trials and systematic reviews, support the use of the TightRope™, indicating it may be a preferable option due to its reduced need for hardware removal and lower risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the TightRope® Fixation in Treating Ankle Syndesmosis Injuries: A Critically Appraised Topic. Street, SB., Rawlins, M., Miller, J.[2021]

The elastic syndesmosis hook plate, made from medical stainless steel alloy, offers a safe and reliable method for treating syndesmosis injuries by allowing for elastic micro-movement without penetrating the bone, reducing the risk of fixation breakage and loosening.

This innovative design simplifies the surgical procedure and effectively stabilizes the joint between the tibia and fibula, making it a promising option for clinical use in internal fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a New Type Elastic Syndesmosis Hook Plate]. Liu, Q., Miao, J., Lin, B., et al.[2018]

A survey of 23 NFL athletic trainers revealed that syndesmotic ankle sprains are commonly caused by rotational injuries, and while various treatments are used, no specific modality has been proven to significantly reduce recovery time.

The most effective reported treatments for speeding up recovery include immobilization, cortico-steroid injections, and a combination of ice and exercise, highlighting the need for further research to establish optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Syndesmotic ankle sprains in football: a survey of national football league athletic trainers. Doughtie, M.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endobutton and cortical screw fixation for the treatment of distal tibiofibular syndesmosis separated]. Lou, YL., Hong, JJ., Shao, XW., et al.[2018]

This pilot study aims to compare the effectiveness of two treatment options for acute syndesmosis ruptures: static screw fixation and the dynamic TightRope® device, focusing on ankle range of motion and power during gait analysis.

The study will involve adult patients with syndesmosis injuries and will assess outcomes through standardized follow-up procedures, including gait analysis and MRI at 6 months, to determine which treatment provides better healing and biomechanical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study. Doll, J., Waizenegger, S., Bruckner, T., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06085586

Fibulink Syndesmosis Repair System With Early Full- ... The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis.

2. aofoundation.org aofoundation.org/approved/approvedsolutionsfolder/2021/fibulink

FIBULINK Syndesmosis Repair System The FIBULINK Syndesmosis Repair System combines the benefits of fixation of a screw and the flexibility of a suture.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT06085586/Prot_SAP_000.pdf

Maimonides Medical Center Protocol May 9, 2022 The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06085586/fibulink-syndesmosis-repair-system-with-early-full-weight-bearing

Fibulink Syndesmosis Repair System With Early Full- ... The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06085586?keyword=%22Fractures%22

Fibulink Syndesmosis Repair System With Early Full- ... All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle ...

6. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2020-10/2284_Desai%202018%20Review2_rev2a.pdf

ARTICLE SYNOPSIS FIBULINK® Syndesmosis Repair System American Orthopedic Foot and Ankle Society (AOFAS) scores at follow-up (average 9.5 months) were favorable (mean 94), varying slightly by type of injury, gender ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20207167&pc=HTN

SYNTHES GMBH FIBULINK(R) SYNDESMOSIS REPAIR KIT/TI The surgery was completed successfully with no surgical delay.Patient was stable.This report is for a fibulink(r) syndesmosis repair kit/ti. Manufacturer ...