Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery

Gait Analysis Clinical Trial

Official title:

Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253624
• Other study ID #: Iayas6
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Gazi University
• Contact: Inci H Ayas
• Phone: 0 312 216 26 21
• Email: inciayass[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Analysis

Intervention

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

Locations

Country	Name	City	State
Turkey	Gazi University Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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