Ankle Lateral LigamentNCT06253624
Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery
A study testing All Arthroscopic ATFL Repair Surgery in people with Ankle Lateral Ligament and Gait Analysis, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Lateral Ligament, Gait Analysis
- What is being tested?
- All Arthroscopic ATFL Repair Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of unilateral ankle instability.
- Planning for all arthroscopic anterior talofibular ligament (ATFL) repair surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital
Ankara, 06560
İnci H Ayas, 0 312 216 26 21, inciayass@gmail.com
inciayass@gmail.com
About this study
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
- Being tested
- All Arthroscopic ATFL Repair Surgery
- Keywords
- ATFL repair, Arthroscopy, Pedobarography, Plantar pressure distribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All Arthroscopic ATFL Repair SurgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| ATFL surgery | Other | All participants will undergo all arthroscopic ATFL repair surgery. Receives: Procedure: All Arthroscopic ATFL Repair Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after the surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Lateral LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Ulunay Kanatlı, Study chair, Gazi UniversityMehmet A Tokgöz, Study director, Gazi UniversityZeynep Hazar, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253624
- Sponsor's protocol ID
- Iayas6
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Pattern Analysis After All Arthroscopic ATFL Repair Surgery
- ClinicalTrials.gov ID
- NCT06253624
- Acronym / sponsor ID
- Iayas6
- Conditions
- Ankle Lateral Ligament, Gait Analysis
- Keywords
- ATFL repair, Arthroscopy, Pedobarography, Plantar pressure distribution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATFL surgery | Other | Procedure: All Arthroscopic ATFL Repair SurgeryAll participants will undergo all arthroscopic ATFL repair surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of unilateral ankle instability.
- Planning for all arthroscopic anterior talofibular ligament (ATFL) repair surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All Arthroscopic ATFL Repair SurgeryThe 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 | Procedure or surgery | ATFL surgery |
Primary outcome
Pedobarography
Time frame: one day before surgery
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.
Pedobarography
Time frame: 3 months after the surgery
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.
Pedobarography
Time frame: 6 months after the surgery
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 secondary outcomes
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
Time frame: one day before surgery
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
Time frame: 3 months after the surgery
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
Time frame: 6 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Ankle Lateral Ligament
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability
Recruiting
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
ATFL, Lateral Ankle Instability
Recruiting
Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.
Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulunay Kanatlı study chair
Gazi University
Mehmet A Tokgöz study director
Gazi University
Zeynep Hazar study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All Arthroscopic ATFL Repair Surgery in people with Ankle Lateral Ligament and Gait Analysis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İnci H Ayas (0 312 216 26 21, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedobarography (time frame: one day before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.