NCT07161128

Brief Summary

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 16, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

June 16, 2025

Last Update Submit

August 30, 2025

Conditions

Keywords

pedobarographygait analysisocd of talusmicrofracture

Outcome Measures

Primary Outcomes (4)

  • Peak Plantar Pressure (kPa) in Pedobarographic analysis

    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

    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

    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

    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 Outcomes (1)

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

    Baseline (1 day before surgery) and 6 months after surgery

Study Arms (1)

Microfracture + Biologic Scaffold

EXPERIMENTAL
Procedure: arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus

Interventions

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.

Microfracture + Biologic Scaffold

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (8)

  • Petersen T, Gordon JA, Kant A, Fava M, Rosenbaum JF, Nierenberg AA. Treatment resistant depression and axis I co-morbidity. Psychol Med. 2001 Oct;31(7):1223-9. doi: 10.1017/s0033291701004305.

    PMID: 11681548BACKGROUND
  • Giannini S, Buda R, Cavallo M, Ruffilli A, Cenacchi A, Cavallo C, Vannini F. Cartilage repair evolution in post-traumatic osteochondral lesions of the talus: from open field autologous chondrocyte to bone-marrow-derived cells transplantation. Injury. 2010 Nov;41(11):1196-203. doi: 10.1016/j.injury.2010.09.028. Epub 2010 Oct 8.

    PMID: 20934692BACKGROUND
  • Ramponi L, Yasui Y, Murawski CD, Ferkel RD, DiGiovanni CW, Kerkhoffs GMMJ, Calder JDF, Takao M, Vannini F, Choi WJ, Lee JW, Stone J, Kennedy JG. Lesion Size Is a Predictor of Clinical Outcomes After Bone Marrow Stimulation for Osteochondral Lesions of the Talus: A Systematic Review. Am J Sports Med. 2017 Jun;45(7):1698-1705. doi: 10.1177/0363546516668292. Epub 2016 Nov 16.

    PMID: 27852595BACKGROUND
  • Steadman JR, Briggs KK, Rodrigo JJ, Kocher MS, Gill TJ, Rodkey WG. Outcomes of microfracture for traumatic chondral defects of the knee: average 11-year follow-up. Arthroscopy. 2003 May-Jun;19(5):477-84. doi: 10.1053/jars.2003.50112.

    PMID: 12724676BACKGROUND
  • Migliorini F, Eschweiler J, Maffulli N, Schenker H, Driessen A, Rath B, Tingart M. Autologous Matrix Induced Chondrogenesis (AMIC) Compared to Microfractures for Chondral Defects of the Talar Shoulder: A Five-Year Follow-Up Prospective Cohort Study. Life (Basel). 2021 Mar 16;11(3):244. doi: 10.3390/life11030244.

    PMID: 33809441BACKGROUND
  • Cheng L, Wang X. Advancements in the treatment of osteochondral lesions of the talus. J Orthop Surg Res. 2024 Dec 6;19(1):827. doi: 10.1186/s13018-024-05314-6.

    PMID: 39639331BACKGROUND
  • Gianakos AL, Yasui Y, Hannon CP, Kennedy JG. Current management of talar osteochondral lesions. World J Orthop. 2017 Jan 18;8(1):12-20. doi: 10.5312/wjo.v8.i1.12. eCollection 2017 Jan 18.

    PMID: 28144574BACKGROUND
  • Ferkel RD, Zanotti RM, Komenda GA, Sgaglione NA, Cheng MS, Applegate GR, Dopirak RM. Arthroscopic treatment of chronic osteochondral lesions of the talus: long-term results. Am J Sports Med. 2008 Sep;36(9):1750-62. doi: 10.1177/0363546508316773.

    PMID: 18753679BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Resident in Orthopaedic Surgery, Principal Investigator

Study Record Dates

First Submitted

June 16, 2025

First Posted

September 8, 2025

Study Start

June 1, 2024

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations