Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery

NCT06253624 | Recruiting

• 1 other identifier: Iayas6
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate alterations in post-surgical gait patterns among patients who have undergone all arthroscopic repair surgery for the anterior talofibular ligament (ATFL) due to ankle instability. The gait biomechanics of patients scheduled for surgery will be assessed preoperatively using pedobarographic analysis. Subsequent changes in walking biomechanics will be evaluated and interpreted at the 3rd and 6th postoperative months. Consequently, the impact of the all arthroscopic anatomical ATFL repair method on walking will be documented.

Conditions

Ankle Lateral Ligament; Gait Analysis

Keywords

ATFL repair; Arthroscopy; Pedobarography; Plantar pressure distribution

Outcome Measures

Primary Outcomes (3)

• Pedobarography

  Pedobarographic analysis involves the completion of the platform, pressure sensors, software, and computer installation for gait analysis. In dynamic analysis, the patient takes a step on the platform at a regular walking speed, with arms relaxed at the sides of the body, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a free position next to the body. Five measurements are separately recorded for both feet during the step, heel strike, and toe lift phases. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, the inner, middle, lateral side of the front of the foot, and the toes. The plantar pressure distribution obtained from the measurement is divided into desired areas (masks). The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.

  one day before surgery

• Pedobarography

  Pedobarographic analysis involves the completion of the platform, pressure sensors, software, and computer installation for gait analysis. In dynamic analysis, the patient takes a step on the platform at a regular walking speed, with arms relaxed at the sides of the body, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a free position next to the body. Five measurements are separately recorded for both feet during the step, heel strike, and toe lift phases. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, the inner, middle, lateral side of the front of the foot, and the toes. The plantar pressure distribution obtained from the measurement is divided into desired areas (masks). The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.

  3 months after the surgery

• Pedobarography

  Pedobarographic analysis involves the completion of the platform, pressure sensors, software, and computer installation for gait analysis. In dynamic analysis, the patient takes a step on the platform at a regular walking speed, with arms relaxed at the sides of the body, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a free position next to the body. Five measurements are separately recorded for both feet during the step, heel strike, and toe lift phases. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, the inner, middle, lateral side of the front of the foot, and the toes. The plantar pressure distribution obtained from the measurement is divided into desired areas (masks). The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.

  6 months after the surgery

Secondary Outcomes (3)

• American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)

  one day before surgery

• American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)

  3 months after the surgery

• American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)

  6 months after the surgery

Study Arms (1)

ATFL surgery

OTHER

All participants will undergo all arthroscopic ATFL repair surgery.

Procedure: All Arthroscopic ATFL Repair Surgery

Interventions

All Arthroscopic ATFL Repair Surgery PROCEDURE

The patients undergo surgery with spinal block, general anesthesia, or a combination of both. During the diagnostic arthroscopy, the anterior compartment is examined with a 4 mm 30-degree camera, and lateral ankle instability is diagnosed arthroscopically

ATFL surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of unilateral ankle instability.
• Planning for all arthroscopic anterior talofibular ligament (ATFL) repair surgery.

You may not qualify if:

• Presence of foot and ankle deformities.
• Presence of orthopedic or neurological pathologies that may affect walking biomechanics.
• History of prior foot and ankle surgery.
• Assessment of surgical stability deemed unsuccessful at the 3rd or 6th month postoperative control.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Study Officials

• Ulunay Kanatlı

  Gazi University

  STUDY CHAIR

• Mehmet A Tokgöz

  Gazi University

  STUDY DIRECTOR

• Zeynep Hazar

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

İnci H Ayas

CONTACT

0 312 216 26 21; inciayass@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research asistant

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: December 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)