Gait Pattern Analysis After Arthroscopic Treament of Osteochondral Defects of Talus

August 30, 2025 updated by: Furkan ARAL, Gazi University

Pedobarographic Evaluation of Gait Biomechanics in Patients Treated With Arthroscopic Microfracture and Biologic Cartilage Scaffold for Osteochondral Defect (OCD) of Talus

The study will investigate alterations in post-surgical gait patterns among patients who have undergone all arthroscopic microfracture and biological scaffold implementation surgery for the osteochondral lesions of talus. 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 6th postoperative months. Consequently, the impact of the all arthroscopic treatment of osteochondral lesions of talus on walking will be documented.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Osteochondral defects (OCDs) of the talus are lesions that extend into the subchondral bone. They most commonly occur after ankle fractures, dislocations, or other ankle injuries. Spontaneous necrosis, systemic vascular disorders, and metabolic diseases have also been implicated in the development of talar OCD.

Current treatment strategies-selected according to lesion size, location, and patient characteristics-range from conservative modalities (weight-bearing restriction, NSAIDs, immobilization) to arthroscopic debridement, bone marrow-stimulating techniques such as microfracture or nanofracture combined with biologic scaffolds, autologous chondrocyte-based procedures (ACI, MACI, AMIC), autologous osteochondral transfers (mosaicplasty/OAT), and more recently, biologic augmentations with platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC).

The microfracture technique is usually performed arthroscopically. Perforation of the subchondral plate recruits mesenchymal stem cells that drive cartilage repair. Concomitant use of a biologic scaffold has been shown to enhance cartilage regeneration and improve functional scores. While microfracture provides an initial stimulus for defect filling, biologic cartilage scaffolds support cell adhesion and foster the formation of hyaline-like tissue. Autologous osteochondral transfers are preferred for larger lesions, and among autologous chondrocyte-based techniques, no meaningful short-term clinical differences have been demonstrated.

Plantar pressure analysis (pedobarography) yields objective information on foot and ankle biomechanics during gait and is widely used to detect changes after orthopedic surgery. By quantifying plantar pressure distribution, pedobarography enables detailed assessment of foot and ankle loading patterns. In patients with talar OCD, gait analyses have shown that the ankle tends to assume a valgus position during walking; medial talar lesions are associated with reduced plantarflexion at the Lisfranc joint, whereas lateral talar lesions demonstrate increased midfoot peak pressure.

This study will evaluate postoperative changes in gait biomechanics-measured by pedobarography-in patients with talar OCD treated arthroscopically with microfracture and a biologic cartilage scaffold. We hypothesize that the abnormal plantar pressure distribution observed preoperatively will normalize after surgery, bringing gait biomechanics closer to those of healthy individuals.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06560
        • Gazi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • presence of osteochondral defect on talus confirmed with MRI
  • planning for arthroscopic microfracture+ biological scaffold 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microfracture + Biologic Scaffold
Procedure: arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus
All enrolled patients will undergo a standardized single-stage arthroscopic procedure under spinal or general anesthesia with the patient supine and the ankle placed in appropriated position. Standard anteromedial and anterolateral portals are established. The talar osteochondral defect is inspected, measured, and any unstable cartilage is sharply débrided to create stable vertical walls, exposing healthy subchondral bone. Using a 1.0- to 1.2-mm awl, multiple perforations are made perpendicular to the lesion base, 3-4 mm apart and ~2-4 mm deep, until uniform "marrow fat-bleeding" is observed-mobilizing mesenchymal stem cells .A sterile, resorbable, type-I/III collagen bilayer scaffold is trimmed to the exact defect footprint using a template fashioned intra-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plantar Pressure (kPa) in Pedobarographic analysis
Time Frame: Baseline (1 day before surgery) and 6 months after surgery
Peak plantar pressure will be assessed using a computerized pedobarographic platform equipped with pressure sensors and dedicated gait analysis software. Patients will walk barefoot at a self-selected, comfortable speed with arms relaxed at the sides, following a natural gait. In each session, five valid gait trials will be recorded. For each trial, the maximum plantar pressure value under the entire foot during stance will be extracted. The mean value of the five trials will be reported. This outcome quantifies the highest load experienced by the plantar surface during walking and will allow comparison of preoperative and postoperative gait biomechanics.
Baseline (1 day before surgery) and 6 months after surgery
Plantar Pressure-Time Integral (kPa·s) in Pedobarograpic Analysis
Time Frame: Baseline (1 day before surgery) and 6 months after surgery
The plantar pressure-time integral will be measured using the same pedobarographic platform. During dynamic gait analysis, patients will complete five valid walking trials at a natural speed. For each trial, the cumulative pressure applied over time to the plantar surface during the stance phase will be calculated and expressed as kPa·s. The average of the five trials will be reported. This measure reflects the duration and magnitude of plantar loading and provides information on changes in gait mechanics following surgery.
Baseline (1 day before surgery) and 6 months after surgery
Plantar Contact Area (cm²) in Pedobarographic Analysis
Time Frame: Baseline (1 day before surgery) and 6 months after surgery
Plantar contact area will be evaluated using the pedobarographic platform during dynamic gait analysis. Patients will walk at a self-selected speed, and five valid gait trials will be collected. For each trial, the total plantar surface area in contact with the platform during stance will be computed and expressed in square centimeters. The mean of the five trials will be reported. This outcome reflects how much of the plantar surface participates in load transfer during walking and will be used to assess functional improvement after surgery.
Baseline (1 day before surgery) and 6 months after surgery
Center of Pressure Excursion Index (%) in Pedobarographic Analysis
Time Frame: Baseline (1 day before surgery) and 6 months after surgery
The Center of Pressure (COP) Excursion Index will be calculated from dynamic pedobarographic recordings. Patients will walk barefoot at a self-selected, comfortable speed, with five valid gait trials collected per session. The COP trajectory during stance will be analyzed, and the mediolateral deviation of the COP path will be expressed as a percentage relative to foot width (Excursion Index). The average value from the five trials will be reported. This outcome reflects dynamic postural control and foot loading patterns during gait and will be compared between the preoperative and postoperative assessments.Baseline (1 day before surgery) and 6 months after surgery
Baseline (1 day before surgery) and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)
Time Frame: Baseline (1 day before surgery) and 6 months after surgery
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.
Baseline (1 day before surgery) and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

June 16, 2025

First Submitted That Met QC Criteria

August 30, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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