Effect of Arthroscopic Microfracture Combined With Stromal Vascular Fraction Therapy on Clinical and Radiological Outcomes in Gonarthrosis: A Prospective Randomized Controlled Trial
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
- Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
研究概览
简要总结
This prospective, randomized controlled clinical trial aims to evaluate the clinical and radiological effects of combining stromal vascular fraction (SVF) therapy with arthroscopic microfracture in patients with knee osteoarthritis. A total of 50 patients with symptomatic gonarthrosis were randomly assigned to either receive arthroscopic debridement and intra-articular SVF injection alone or SVF injection combined with arthroscopic debridement, microfracture. The primary outcome measures include changes in VAS, WOMAC, and Lysholm scores at 3, 6, 12, and 24 months. Radiological assessment was performed using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system. The study hypothesis is that the combination therapy will result in superior clinical and cartilage regeneration outcomes compared to SVF treatment alone.
详细描述
This single-center, prospective, randomized controlled clinical study was conducted to compare the efficacy of stromal vascular fraction (SVF) therapy alone versus SVF therapy combined with arthroscopic microfracture in patients diagnosed with knee osteoarthritis (gonarthrosis). A total of 50 patients with symptomatic medial compartment osteoarthritis, classified as Kellgren-Lawrence grade II-III, were enrolled and randomized into two groups:
Group A (n=25): Participants initially underwent arthroscopic debridement and microfracture, followed by intra-articular injection of autologous stromal vascular fraction (SVF)
Group B (n=25): Participants underwent arthroscopic debridement, after which intra-articular injection of autologous stromal vascular fraction (SVF) was administered. Microfracture was not performed in this group.
SVF was isolated from autologous lipoaspirate obtained via mini-liposuction and processed intraoperatively using a closed system. Arthroscopic microfracture was performed with standard technique, targeting cartilage defects in the medial and lateral femoral condyle.
Clinical evaluations were performed preoperatively and at 3, 6, 12, and 24 months post-intervention using:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were blinded to their treatment allocation throughout the study. Although the operating surgeons were aware of the intervention due to the nature of the surgical procedures, outcome assessment was conducted by an independent radiologist who was blinded to group allocation.
入排标准
- 年龄范围
- 49 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage II-III osteoarthritis of the knee
- •Patients with a mechanical axis deviation not exceeding 15 mm on the anteroposterior orthoroentgenogram x-ray
排除标准
- •Patients with deformities on anteroposterior and lateral x-ray examinations
- •Patients with a BMI greater than 35 kg/m2
- •Patients diagnosed with secondary gonarthrosis (Rheumatoid arthritis, secondary to trauma)
- •Patients with a history of intra-articular injections within the last 6 months
- •Patients with a history of knee joint surgery
结局指标
主要结局
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention
The WOMAC index (range: 0-96) is a validated questionnaire evaluating pain, stiffness, and physical function in osteoarthritis patients. Higher scores indicate worse symptoms. This outcome measures change in WOMAC score following SVF therapy with or without microfracture.
Change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
时间窗: Baseline and 12,24 months after the intervention
The WORMS cartilage subscore (range: 0-84) is a semiquantitative MRI-based system assessing the morphology and integrity of articular cartilage in the knee joint. Higher scores indicate more severe cartilage damage. This outcome specifically evaluates radiological changes in cartilage structure after SVF therapy with or without microfracture.
次要结局
- Change in Lysholm Knee Score(Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention)
- Change in VAS (Visual Analog Scale) for Pain(Baseline, 3 months, 6 months, 12 months, and 24 months after the intervention)
研究者
Mehmet Yağız Yenigün
Resident Doctor
Istanbul University