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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for ankle syndesmosis injuries, which occur when the bones in the lower leg and ankle become unstable due to an injury. The study examines screw fixation, where screws hold bones in place, and suture button fixation, which uses a flexible suture with anchors. The main goal is to determine which method better supports recovery, movement, and walking. Suitable participants have an ankle injury affecting the tibia and fibula bones but without open fractures or severe instability. As an unphased trial, this study allows patients to contribute to research that may enhance treatment options for future patients.

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

A previous study demonstrated that using a suture button to fix ankle syndesmosis injuries is safe. Research indicates that patients tolerate it well, experiencing fewer complications compared to other methods. One study highlighted its safety, noting very few negative effects and positive outcomes for patients.

For screw fixation, studies have shown it is also safe for treating ankle syndesmosis injuries. Research found that patients could safely bear weight on their ankle after surgery, without issues like implant failures or infections. However, some studies suggest that using a suture button might lead to better movement and function.

Both treatments are commonly used and considered safe, with no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for ankle syndesmosis injury because they offer innovative approaches compared to the traditional screw fixation method. Suture button implants present a different strategy by using a combination of suture and anchor to stabilize the syndesmosis, potentially allowing for more natural movement and reducing complications associated with screws. This approach may lead to better recovery outcomes and improved patient comfort by minimizing the need for hardware removal. The exploration of these techniques aims to enhance recovery by providing alternatives that could be more effective or comfortable for patients.

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

This trial will compare suture button fixation with screw fixation for treating ankle syndesmosis injuries. Research has shown that both methods are effective. Studies suggest that suture button fixation often leads to better joint stability and improved range of motion post-surgery. A review of multiple studies found that patients with suture button fixation generally experienced fewer complications than those with screw fixation. However, screw fixation remains an effective method, with some research highlighting its long-term success and reliability. Patient feedback has not clearly favored one method over the other, indicating that both treatments can be beneficial. ^{2 6 7 8 9}

Who Is on the Research Team?

Sarah M Putnam, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11409161/

A Prospective Study on Fixation of Syndesmotic Ankle Injury Functional outcomes at six months, as measured by the AOFAS score, were significantly better in the Tight Rope group, with 87.5% achieving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11755497/

Long-term Clinical Outcomes After Syndesmosis Fixation ... Acute syndesmosis fixation failure was observed in 9 patients (2%) at early stage of the follow-up at 6 weeks postoperatively in 5 cases and at ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06137-9

Does syndesmotic fixation technique impact complication ... Syndesmotic fixation with either SB or STA reduces complications compared to screw. While this study was underpowered to detect differences in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1067251621002635

The Clinical Efficacy of Suture-Button Fixation and Trans ... The aim of this study is to investigate the clinical efficacy of suture button fixation and trans-syndesmotic screw fixation in the treatment of ankle fracture.

5. aoj.amegroups.org aoj.amegroups.org/article/download/8781/9290

Comparison of the outcomes of syndesmotic ankle fractures ... this injury are static fixation with syndesmosis screws and dynamic fixation with a suture button. Intramedullary fibular nails are also an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366565/

Efficacy and safety of different fixation methods for acute ... Acute unstable syndesmosis injuries require accurate reduction and stable fixation to improve short-term and long-term outcomes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1008127525000823

Fixation methods in syndesmosis injuries: Screw vs. elastic ... Meta-analyses have yielded inconsistent conclusions regarding whether SS or SB fixation is superior. A 2016 meta-analysis favored SB for better ...

8. injuryjournal.com injuryjournal.com/article/S0020-1383(23)00380-7/abstract

Protected immediate weight-bearing is safe after fixation of ... Our results show that immediate weight-bearing is safe with maintenance of the reduction, no implant failures, no breakage of the screw and no infection.

9. aoj.amegroups.org aoj.amegroups.org/article/view/8781/html

Comparison of the outcomes of syndesmotic ankle fractures ... Dynamic fixation showed better functional outcomes than static fixation and fibular nailing and a lower reoperation rate compared to static fixation. • The ...