Suture Button vs Screw Fixation for Ankle Syndesmosis Injury

Recruiting at 3 trial locations

Overseen By Sarah M Putnam, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Open fracture, Neuropathy, Non-ambulatory, 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: 2

Duration: Surgery and immediate postoperative period

78 Participants Needed

Trial Summary

What is the purpose of this trial?

Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Suture Button vs Screw Fixation for Ankle Syndesmosis Injury?

Research shows that suture button fixation for ankle syndesmosis injuries allows for early weightbearing and has similar effectiveness to traditional screw fixation, with the added benefit of potentially avoiding additional surgeries. It also supports more natural ankle movement while maintaining stability, which can lead to better early-stage recovery outcomes. ^{1 2 3 4 5}

How does suture button fixation differ from screw fixation for ankle syndesmosis injuries?

Suture button fixation allows for early weightbearing and has lower requirements for routine removal compared to traditional screw fixation, which may require hardware removal. It also tends to have a higher initial cost but potentially lower long-term costs due to fewer reoperations. ^{1 2 3 6 7}

Research Team

Sarah M Putnam, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for adults over 19 with a specific ankle injury called syndesmosis instability, often part of rotational ankle fractures. Candidates should have stable fibula fractures and no prior trauma or surgery to the injured ankle. Those with unstable fracture patterns, previous stability in the syndesmosis, non-ambulatory status, lower extremity neuropathy, or who used walking aids before their injury cannot participate.

Inclusion Criteria

Isolated rotational ankle injury

I am 19 years old or older.

Length-stable fibula fracture pattern

Exclusion Criteria

I used a walking aid before my injury.

My fracture is unstable and may include a specific type called Maisonneuve.

I cannot walk by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either screw fixation or suture fixation for syndesmotic injury

Surgery and immediate postoperative period

Postoperative Follow-up

Participants are monitored for clinical outcomes, patient-reported outcomes, and gait patterns

1 year

Routine clinical follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

Long-term Follow-up

Participants are monitored for long-term outcomes such as maintenance of syndesmotic reduction and development of radiographic arthritis

1 year

Treatment Details

Interventions

• Suture Button vs Screw Fixation

Trial Overview The study compares two treatments for an ankle injury known as syndesmosis: suture button fixation versus screw fixation. It aims to see which method leads to better gait outcomes post-surgery since current evidence doesn't clearly show one being superior over the other in terms of patient-reported results.

Participant Groups

Group I: Screw Fixation Active Control 1 Intervention

Traditional fixation method of placing one or two screws across the syndesmosis.

Group II: Suture Button Active Control 1 Intervention

Suture button implants which use a suture and anchor to repair the syndesmosis

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

The suture-button technique for dynamic fixation of syndesmosis injuries showed better functional outcomes (AOFAS score of 91.08) compared to traditional static fixation (AOFAS score of 87.95) in a review of 210 patients over an average follow-up of about 25 months.

Dynamic fixation resulted in lower reoperation rates (10.5% for suture-button vs. 38.5% for static fixation) and fewer complications, making it a safer and more effective option for stabilizing syndesmosis injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on dynamic versus static distal tibiofibular fixation. Inge, SY., Pull Ter Gunne, AF., Aarts, CAM., et al.[2022]

This review aims to compare the effectiveness of three fixation methods for acute ankle syndesmosis injuries: metal screw fixation, bioabsorbable screw fixation, and suture button fixation.

The goal is to evaluate the safety and efficacy of these treatment strategies based on available evidence, helping to guide clinical decisions for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fixation methods for acute injuries of the ankle syndesmosis: a systematic review protocol. Gieroba, TJ., Munn, Z., Cundy, PJ., et al.[2018]

In a study of 76 patients with ankle fractures and syndesmosis injuries, suture button fixation demonstrated higher early-stage ankle function scores and allowed for earlier full weightbearing compared to traditional syndesmotic screw fixation.

Both fixation methods showed equivalent overall efficacy and complication rates, but the suture button offers advantages such as reduced need for routine removal and improved early recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Efficacy of Suture-Button Fixation and Trans-Syndesmotic Screw Fixation in the Treatment of Ankle Fracture Combined With Distal Tibiofibular Syndesmosis Injury: A Retrospective Study. Xu, Y., Kang, R., Li, M., et al.[2022]

The systematic review and meta-analysis of 15 studies involving 86 cadaveric limbs found that both single and double suture button configurations provide similar rotational stability for syndesmotic injuries, indicating that either option can be effective for maintaining fibular position.

However, the double suture button configuration showed a significant reduction in sagittal fibular translation compared to the single button, suggesting it may offer enhanced stability in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical profile of varying suture button constructs in cadaveric specimens: a systematic review and meta-analysis. Wixted, CM., Luo, EJ., Stauffer, TP., et al.[2023]

Suture-button devices, specifically ZipTight and TightRope, were tested for their fixation strength in syndesmosis injuries using 10 cadaveric leg pairs, showing adequate fixation strength with failure torques exceeding 20 Nm, which is sufficient for healing.

While suture-button devices provided less torsional strength compared to traditional screw fixation, they still maintained diastasis below 2.0 mm during cyclic loading, indicating they can effectively stabilize syndesmosis injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of syndesmotic injury fixation methods using a cadaveric model. Ebramzadeh, E., Knutsen, AR., Sangiorgio, SN., et al.[2022]

The cost-effectiveness of syndesmotic fixation methods, such as suture button fixation versus screw fixation, largely depends on the rate of hardware removal, with suture buttons being more economical if screws are frequently removed.

If syndesmosis screws are removed 100% of the time, suture button fixation can save between $85,000 and $194,656 per 100 ankles, highlighting the importance of considering hardware removal rates in surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis of ankle syndesmosis internal fixation. Weber, AC., Hull, MG., Johnson, AJ., et al.[2022]

In a meta-analysis of 5 randomized controlled trials involving 280 patients, suture button (SB) fixation showed a statistically significant higher AOFAS score at 1 year compared to syndesmosis screws (SS), indicating better functional outcomes, although the clinical significance of this difference is uncertain.

SB fixation also had a significantly lower rate of implant failures compared to SS, suggesting it may be a more reliable option for managing ankle syndesmotic injuries, despite a marginally higher risk of infection and wound issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture button versus syndesmosis screw constructs for acute ankle diastasis injuries: A meta-analysis and systematic review of randomised controlled trials. Onggo, JR., Nambiar, M., Phan, K., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review on dynamic versus static distal tibiofibular fixation. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Fixation methods for acute injuries of the ankle syndesmosis: a systematic review protocol. [2018]

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

The Clinical Efficacy of Suture-Button Fixation and Trans-Syndesmotic Screw Fixation in the Treatment of Ankle Fracture Combined With Distal Tibiofibular Syndesmosis Injury: A Retrospective Study. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Biomechanical profile of varying suture button constructs in cadaveric specimens: a systematic review and meta-analysis. [2023]

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

Biomechanical comparison of syndesmotic injury fixation methods using a cadaveric model. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Cost analysis of ankle syndesmosis internal fixation. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Suture button versus syndesmosis screw constructs for acute ankle diastasis injuries: A meta-analysis and systematic review of randomised controlled trials. [2020]