Impact of High Tibial Osteotomy in Preventing Disease Progression in Medial Knee Osteoarthritis: Quantifying the Effects on Cartilage and Subchondral Bone by Using a Combined Biomechanical and Medical Imaging Approach.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Score for Knee function 3
研究概览
简要总结
High tibial osteotomy (HTO) surgical procedure can lead to clinically significant improvements in the cartilage and in subchondral bone quality, with a slow down of the osteoarthritis (OA) progression.
Aim of the project is to:
(i) clinically validate a 3D planned HTO surgical approach, through a quantitative grading of OA progression in a prospective randomized case-control clinical trial; (ii) correlate the internal knee loads with the changes assessed in cartilage and subchondral bone status to verify the hypothesis that HTO induced mechanical changes are associated with clinically significant OA improvements; (iii) relate imaging data with cartilage and subchondral bone mechanical properties, in order to classify OA progression in a more sensitive manner and allow a more precise diagnosis of the pathology stage.
详细描述
High tibial osteotomy (HTO) is a well tracked procedure aimed to reduce the overload in the medial compartment of the varus knee with early and mid-stage osteoarthritits (OA).
Clear evidence still lacks regarding whether it has the ability to determine regenerative processes in the cartilage and subchondral bone. Furthermore, prospective randomised analysis regarding the effectiveness of HTO with respect to conservative treatment are needed.
The hypothesis is that an accurately planned HTO surgery result in measurable changes in the internal knee biomechanics, leading to clinically significant improvements in cartilage and subchondral bone quality, slowing down OA progression.
Accurate HTO could thus become the first choice in young/fit patients with medial knee OA, preserving their bone stock, slowing down OA progression and eventually reversing its trend, with a high impact on patients' quality of life and on public health system spending.
Aims of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medial knee osteoarthritis in varus knee malalignment (> 4°)
排除标准
- •Inability to sign informed consent
- •joint infection
- •inflammatory chronic disease
- •previous major surgical procedure of the indexed knee (simple arthroscopy or meniscectomy would be not considered major procedure)
- •BMI > 30
结局指标
主要结局
Clinical Score for Knee function 3
时间窗: 3 years
IKDC Subjective and objective Knee Evaluation Form. The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. IKDC evaluation form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.
Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI).
时间窗: 3 years
Baseline and one-year follow-up cartilage status will be assessed in order to detect changes in cartilage status after the treatment. Quantitative cartilage assessment will be perfomed using T1rho and T2 mapping sequences which will be gathered during MRI.
Clinical Score for Knee function 1
时间窗: 3 years
Marx Activity Rating Scale (MARS) score is an outcome reporting measure to evaluate the activity level of patients with various knee disorders who participate in sports. The MARS focuses on four activity points: running, deceleration, cutting (changing directions while running) and pivoting. MARS form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.
Subchondral bone morphological and structural analysis via Cone Bean Computed Tomography (CBCT) of the knee.
时间窗: 3 years
Baseline and one-year follow-up subchondral bone morphological and structural features will be assessed via CBCT analysis, which allow to perform a weight-bearing assessment of the knee bone status and morphology.
Clinical Score for Knee function 2
时间窗: 3 years
The Knee Injury and Osteoarthritis Outcome score KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.
次要结局
- Scores for general health(3 years)
- Gait analysis assessment(3 years)
- Scores for pain(3 years)