Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis

March 4, 2025 updated by: El-Sayed Sherif Soliman El-Gamasy, Tanta University

Comparative Study Between Syndesmotic Screw and Suture Button in Ankle Syndesmotic Diastasis

The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The term syndesmotic injury is used to describe a lesion of the ligaments that connect the distal fibula and the tibial notch surrounded on both sides by the anterior and posterior tibial tubercles, with or without an associated injury of the deltoid ligament.

Accuracy and maintenance of syndesmosis reduction are considered the key elements in the treatment of ankle fractures. Screw fixation is considered the gold standard treatment for an unstable syndesmosis injury.

Button and suture construction with a medial-lateral metallic button and suture system offers an alternative method for repairing the distal tibio-fibular joint. Suture-button design has been shown to maintain the reduction, facilitating physiologic stability of the ankle mortise. This may allow early physiological motion, leading to earlier ligament healing and potentially earlier loading, which may produce better clinical results. However, this system is more expensive than the screw method and it may gradually relax under weightbearing conditions. Therefore, whether this device is a suitable alternative, and how many devices are needed for adequate stability are not yet known.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Unstable unilateral syndesmotic injuries that was considered by the attending staff surgeon to require surgical fixation, including:

  • Age : 18 - 60 years old.
  • Closed or grade I open fractures are included.
  • Isolated syndesmotic injury.
  • associated lateral malleolus fracture with talar shift.
  • Associated with Bimalleolar fractures.
  • Associated with Trimalleolar fractures that did not require posterior fragment fixation (typically <25% of articular surface).

Exclusion Criteria:

- Exclusion criteria include patient and injury specific factors.

Patient-related exclusion factors included:

  • Skeletal immaturity.
  • Previous ipsilateral ankle surgery.
  • Non-ambulatory status before injury.
  • Inability to comply with postoperative protocol (i.e., advanced dementia).
  • Medical unfit patients for surgery.
  • Uncontrolled diabetes mellitus with charcot joint or peripheral neuropathy.
  • Polytrauma patients.

Injury-related exclusion factors included:

  • Grade II or III open fractures
  • Tibial plafond fractures
  • Posterior malleolar fractures requiring fixation (typically >25% articular surface involved).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury
Procedure: Suture button fixation
Patients undergoing suture button fixation of syndesmosis injury.
Other Names:
  • Group A
Experimental: Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury
Procedure: Syndesmotic screw fixation
Patients undergoing syndesmotic screw fixation of syndesmosis injury.
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The American Orthopaedic Foot and Ankle Society (AOFAS)
Time Frame: 12 months postoperatively
As an interpretation of the American Orthopaedic Foot and Ankle Society (AOFAS) score, excellent results with score between (95-100). Good results between (75-94). Fair results between (51-74). Poor results between (0-50).
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain
Time Frame: 12 months postoperatively
Degree of pain was assessed using an interpretation of visual analogue scale (VAS) score, No pain with score 0, mild pain with score between (1-3), moderate pain with score between (4-7) and severe pain with score between (8-10). VAS was assessed at 6 weeks, 6 months and 12 months postoperatively.
12 months postoperatively
Ankle Range of motion (ROM)
Time Frame: 12 months Postoperatively

Motion of the ankle occurs primarily in the sagittal plane, with plantar- and dorsiflexion occurring predominantly at the tibiotalar joint. Overall Ankle range of motion (ROM) in the sagittal plane of between 65 and 75°, moving from 10 to 20° of dorsiflexion through to 40-55° of plantarflexion.

Sagittal motion (flexion plus extension) Normal or mild restriction (30° or more) : 8 Moderate restriction (15°-29°) : 4 Severe restriction (less than 15°) : 0
12 months Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 36264MS76/6/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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