Gait Pattern Analysis After Arthroscopic Treament of Osteochondral Defects of Talus

Official title

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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Peak Plantar Pressure (kPa) in Pedobarographic analysis [Time frame: 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]
• Plantar Contact Area (cm²) in Pedobarographic Analysis [Time frame: 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]

Secondary outcome measures (1)

• American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS) [Time frame: Baseline (1 day before surgery) and 6 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gazi University Hospital — Ankara

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 18753679

Identifiers

NCT: NCT07161128 · Gazi University Hospital

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗