Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis

NCT06856980 | Not Yet Recruiting

• 1 other identifier: 36264MS76/6/23
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Syndesmotic Screw; Suture Button; Fixation; Ankle Syndesmotic Diastasis

Outcome Measures

Primary Outcomes (1)

• The American Orthopaedic Foot and Ankle Society (AOFAS)

  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 Outcomes (2)

• Degree of pain

  12 months postoperatively

• Ankle Range of motion (ROM)

  12 months Postoperatively

Study Arms (2)

Suture button fixation

EXPERIMENTAL

Patients undergoing suture button fixation of syndesmosis injury

Procedure: Suture button fixation

Syndesmotic screw fixation

EXPERIMENTAL

Patients undergoing syndesmotic screw fixation of syndesmosis injury

Procedure: Syndesmotic screw fixation

Interventions

Suture button fixation PROCEDURE

Patients undergoing suture button fixation of syndesmosis injury.

Also known as: Group A

Suture button fixation

Syndesmotic screw fixation PROCEDURE

Patients undergoing syndesmotic screw fixation of syndesmosis injury.

Also known as: Group B

Syndesmotic screw fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Central Study Contacts

El-Sayed S El-Gamasy, MBBCh

CONTACT

002 01206220396; elsayed.sherif@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Orthopedic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)