Suture Button vs Fibulink Fixation for Ankle Injury

Overseen By William Kent, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Severe systemic disease, Pregnancy, Prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical methods for treating ankle injuries requiring surgery. Participants will receive either a suture button (Arthrex Tightrope) or a Fibulink implant (Synthes Fibulink) to repair the syndesmosis, a joint area in the ankle. Researchers will observe pain levels, recovery time, and overall ankle function to determine which method is more effective. This trial suits individuals with an ankle fracture and a syndesmotic injury needing surgery who can understand the consent information. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for ankle injuries.

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 is best to discuss this with the study team or your doctor.

What prior data suggests that these fixation methods are safe for ankle injuries?

Research has shown that both Arthrex Tightrope and Synthes Fibulink are generally safe for treating ankle injuries. The Arthrex Tightrope stabilizes the ankle and often remains in place without removal. Studies have found it supports quick recovery, allowing people to resume activities in less than two months, with no major safety concerns reported.

The Synthes Fibulink system allows the ankle to move naturally. Research indicates that it enables early weight-bearing without causing additional problems, suggesting it is safe and aids in effective healing.

Both treatments are promising for safety and effectiveness, making them good options for managing ankle injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ankle injuries because they offer innovative approaches to syndesmosis fixation. The Arthrex Tightrope uses a high-tension suture with a button-based anchor system, which provides flexibility and potentially less irritation compared to traditional metal screws. On the other hand, the Synthes Fibulink employs a screw-based anchor system, known for robust stabilization. These methods aim to improve patient outcomes by offering alternatives to the standard metallic screw fixation, promising enhanced stability or reduced complications in ankle injury recovery.

What evidence suggests that this trial's treatments could be effective for ankle syndesmosis injuries?

Research has shown that the Arthrex Tightrope, one of the treatments in this trial, effectively stabilizes ankle injuries. It often results in fewer surgeries and complications for patients by reducing the need to remove implants compared to traditional screws. The Synthes Fibulink system, another treatment option in this trial, is designed to maintain proper alignment of ankle bones after an injury. Early studies suggest that Fibulink offers strong and stable support. Both treatments in this trial aim to enhance recovery and outcomes for ankle injuries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with an acute ankle syndesmosis injury that needs surgery. Candidates must understand the consent form and can't be in another drug study, imprisoned, pregnant, have severe systemic disease not managed medically, or prefer a specific implant.

Inclusion Criteria

I need surgery for a broken ankle with a specific ligament injury.

You can read and understand the information provided in the consent form.

Exclusion Criteria

You have participated in another study involving medication within the last month that could affect the results of this study.

I do not have any severe illnesses that are not under control.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation with either a suture button or Fibulink implant for acute ankle syndesmosis injuries

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness, including pain, range of motion, and functional scores

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Arthrex Tightrope
• Synthes Fibulink

Trial Overview

The study compares two surgical procedures to fix ankle syndesmosis injuries: one uses a suture button (Arthrex Tightrope) and the other uses Fibulink implant. Patients are randomly assigned to either method to see which one leads to better healing and recovery.

How Is the Trial Designed?

Group I: Synthes Fibulink Experimental Treatment 1 Intervention

Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.

Group II: Arthrex Tightrope Active Control 1 Intervention

Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

Arthrex Tightrope is already approved in United States for the following indications:

Approved in United States as Arthrex Tightrope for:

• Ankle syndesmosis injuries
• Ankle fractures with syndesmosis disruption

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 53 patients with unstable ankle fractures, the use of the TightRope® suture-button device resulted in a lower reoperation rate (9%) compared to syndesmotic screws (21%), indicating better overall outcomes with the suture-button fixation.

Patients treated with the TightRope® also experienced fewer implant-related issues and a quicker return to weight-bearing, suggesting it may provide superior stabilization and fewer complications than traditional syndesmotic screws.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture-Button Versus Syndesmotic Screw Fixation of Ankle Fractures: A Comparative Retrospective Review Over One Year. Yawar, B., Hanratty, B., Asim, A., et al.[2021]

The study of 49 patients with ankle diastasis showed that using the Arthrex Tightrope™ technique for syndesmosis fixation resulted in satisfactory stabilization and a mean AOFAS score of 85.57, indicating good functional outcomes.

The modified technique used in 31 cases significantly reduced the rate of hardware removal to zero, compared to three cases in the standard technique group, highlighting its potential to minimize soft-tissue complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tightrope fixation of ankle syndesmosis injuries: clinical outcome, complications and technique modification. Naqvi, GA., Shafqat, A., Awan, N.[2022]

The Ankle TightRope(®) fixation method for ankle syndesmosis injuries has shown benefits such as facilitating early weightbearing and reducing the need for implant removal, leading to quicker recovery times.

Despite its advantages, the TightRope(®) technique can lead to serious complications, including chronic osteomyelitis and suture-button migration, highlighting the need for careful monitoring and management of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteomyelitis after TightRope(®) fixation of the ankle syndesmosis: a case report and review of the literature. Hong, CC., Lee, WT., Tan, KJ.[2016]

The TightRope technique for syndesmosis fixation in ankle fractures was evaluated in a study of 54 patients, with a follow-up period averaging 28.64 months, showing excellent clinical outcomes with a mean AOFAS score of 93.11 and a FADI score of 130.11.

Eighty percent of patients reported their outcomes as excellent or very good, indicating that TightRope allows for flexible fixation and early rehabilitation, making it a promising option for treating syndesmotic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of TightRope fixation for ankle syndesmosis injuries: our experience. Bondi, M., Rossi, N., Pizzoli, A., 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]

The Ankle Tightrope fixation method allows for physiological motion at the ankle joint, enabling early range of motion and weight bearing without the need for a second surgery to remove the device, which is a significant advantage over traditional syndesmosis screw fixation.

While the Ankle Tightrope has shown benefits, it is associated with complications such as knot prominence, wound issues, and, notably, tendon entrapment from the medial button, highlighting the need for careful surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibialis anterior tendon entrapment after ankle tightrope insertion for acute syndesmosis injury. Welck, MJ., Ray, P.[2016]

Citations

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Tightrope fixation of ankle syndesmosis injuries

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11663228/

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Our study found that the use of TightRope devices is associated with lower removal rates in comparison to syndesmotic screws.

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sciencedirect.com

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Tightrope fixation of ankle syndesmosis injuries

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Effectiveness of the TightRope® fixation in treating ankle syndesmosis injuries: a critically appraised topic. J Sport Rehabil. 2021;30(4):676-679. doi ...

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cureus.com

cureus.com/articles/339152-an-unusual-outcome-using-the-tightrope-system-in-syndesmotic-injury-management-a-case-report

An Unusual Outcome Using the TightRope® System in ...

This case report presents a scenario of persistent wound discharge and implant-related issues following TightRope fixation for a syndesmotic ...

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arthrex.com

arthrex.com/foot-ankle/knotless-tightrope-syndesmosis

Syndesmosis TightRope® XP Implant System

The Syndesmosis TightRope® XP implant system features a unique delivery mechanism that allows surgeons to insert the implant without pulling a needle ...

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Management of High Ankle Sprains Utilizing the Tightrope ...

This emerging strategy has shown promise in reducing recovery time as it is now possible to return to sport in less than 2 months after a tightrope repair.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05626036

Randomized Controlled Trial Comparing Suture Button ...

Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis ...

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sciencedirect.com/science/article/pii/S2667396722001173

Early weightbearing after dynamic stabilization of the ankle ...

In conclusion, the Tightrope® XP provides a safe and effective method for treatment of ankle fractures with syndesmosis disruption and supports early ...