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Osteochondral Defects of TalusNCT07161128

Gait Pattern Analysis After Arthroscopic Treament of Osteochondral Defects of Talus

A study testing arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus in people with Osteochondral Defects of Talus and Gait Analysis, run by Gazi University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Gazi University Hospital

    Ankara, Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus
Keywords
pedobarography, gait analysis, ocd of talus, microfracture
Medical subject headings
Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talusProcedure or surgery

    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.

Study groups in NCT07161128
Study groupRoleWhat they receive
Microfracture + Biologic ScaffoldExperimentalNot described
Receives: Procedure: arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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

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

Secondary outcomes (1)
  1. 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: Baseline (1 day before surgery) and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start1 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07161128
Sponsor's protocol ID
Gazi University Hospital
Status last verified
Aug 2025
First submitted
16 Jun 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 11681548
  • 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.

    PubMed 20934692
  • 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.

    PubMed 27852595
  • 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.

    PubMed 12724676
  • 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.

    PubMed 33809441
  • 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.

    PubMed 39639331
  • 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.

    PubMed 28144574
  • 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.

    PubMed 18753679

Questions about this trial

What is this clinical trial studying?

A study testing arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus in people with Osteochondral Defects of Talus 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 3 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plantar Pressure (kPa) in Pedobarographic analysis (time frame: Baseline (1 day before surgery) and 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07161128, which also lists 8 linked publications.

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 8 Sep 2025.

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