Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Gait Analysis; Ankle Lateral Ligament
• Intervention / Treatment: Procedure: All Arthroscopic ATFL Repair Surgery

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İnci H Ayas; Phone Number: 0 312 216 26 21; Email: inciayass@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Gazi University Hospital
    • Contact: İnci H Ayas; Phone Number: 0 312 216 26 21; Email: inciayass@gmail.com
    • Contact: Email: inciayass@gmail.com
    • Principal Investigator: İnci H Ayas
    • Sub-Investigator: Asim Ahmadov
    • Sub-Investigator: Furkan Aral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ATFL surgery; All participants will undergo all arthroscopic ATFL repair surgery.	Procedure: All Arthroscopic ATFL Repair Surgery; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)	The hindfoot score comprises nine questions that assess pain, function, and alignment. Within the survey, one question pertains to pain, seven questions address function, and one question relates to alignment. The pain section is appraised on a scale of 40 points, the function section on 50 points, and the alignment section on 10 points, summing up to a total of 100 points. A higher score indicates better functionality.	one day before surgery
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)	The hindfoot score comprises nine questions that assess pain, function, and alignment. Within the survey, one question pertains to pain, seven questions address function, and one question relates to alignment. The pain section is appraised on a scale of 40 points, the function section on 50 points, and the alignment section on 10 points, summing up to a total of 100 points. A higher score indicates better functionality.	3 months after the surgery
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)	The hindfoot score comprises nine questions that assess pain, function, and alignment. Within the survey, one question pertains to pain, seven questions address function, and one question relates to alignment. The pain section is appraised on a scale of 40 points, the function section on 50 points, and the alignment section on 10 points, summing up to a total of 100 points. A higher score indicates better functionality.	6 months after the surgery

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Zeynep Hazar, Gazi University; Study Chair: Ulunay Kanatlı, Gazi University; Study Director: Mehmet A Tokgöz, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Arthroscopy; Plantar pressure distribution; Pedobarography; ATFL repair
• Other Study ID Numbers: Iayas6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No