Pedobarographic Evaluation of Gait Biomechanics in Patients Treated With Arthroscopic Microfracture and Biologic Cartilage Scaffold for Osteochondral Defect (OCD) of Talus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak Plantar Pressure (kPa) in Pedobarographic analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of osteochondral defect on talus confirmed with MRI
- •planning for arthroscopic microfracture+ biological scaffold surgery
排除标准
- •presence of foot and ankle deformities
- •Presence of orthopedic or neurological pathologies that may affect walking biomechanics.
- •History of prior foot and ankle surgery.
研究组 & 干预措施
Microfracture + Biologic Scaffold
干预措施: arthroscopic microfracture and biological scaffold implementation for osteochondral defects of talus (Procedure)
结局指标
主要结局
Peak Plantar Pressure (kPa) in Pedobarographic analysis
时间窗: 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.
Plantar Pressure-Time Integral (kPa·s) in Pedobarograpic Analysis
时间窗: 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.
Plantar Contact Area (cm²) in Pedobarographic Analysis
时间窗: 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.
Center of Pressure Excursion Index (%) in Pedobarographic Analysis
时间窗: 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
次要结局
- American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)(Baseline (1 day before surgery) and 6 months after surgery)
研究者
Furkan ARAL
Chief Resident in Orthopaedic Surgery, Principal Investigator
Gazi University