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

Trial Summary

What is the purpose of this trial?

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis 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 data supports the effectiveness of the treatment Arthrex Tightrope for ankle injuries?

Research shows that the Arthrex Tightrope treatment for ankle injuries results in fewer implant-related problems and a lower need for implant removal compared to traditional screw fixation. It also allows for quicker return to weight-bearing and slightly better stability, making it a promising option for managing ankle syndesmosis injuries. ^{1 2 3 4 5}

Is the suture button fixation method generally safe for humans?

The suture button fixation method, such as the Arthrex TightRope, is generally considered safe, but it can have complications like soft tissue irritation, infection, and wound issues. Some studies report fewer implant-related problems compared to traditional screw fixation, but there are risks of tendon entrapment and osteomyelitis (bone infection) in rare cases. ^{1 2 3 4 6}

How is the TightRope treatment for ankle injuries different from other treatments?

The TightRope treatment for ankle injuries is unique because it allows for natural movement at the joint, supports early weight-bearing, and typically does not require a second surgery to remove the implant, unlike traditional screw fixation which restricts joint motion and often needs removal. ^{1 2 3 4 6}

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Osteomyelitis after TightRope(®) fixation of the ankle syndesmosis: a case report and review of the literature. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Suture-Button Versus Syndesmotic Screw Fixation of Ankle Fractures: A Comparative Retrospective Review Over One Year. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tightrope fixation of ankle syndesmosis injuries: clinical outcome, complications and technique modification. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Tibialis anterior tendon entrapment after ankle tightrope insertion for acute syndesmosis injury. [2016]

5. England 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. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

The use of TightRope fixation for ankle syndesmosis injuries: our experience. [2018]