Arthrosocpic Treatment of Knee Chondral Lesions: Clinical, MRI and Histologic Comparison Between the Use of PRP vs ADSCs in Addition to Marrow Stimulation Techniques
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in knee clinical function questionnaire (KOOS)
研究概览
简要总结
The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries.
Participants will:
Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP).
Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee pain and functional limitation for at least three months, monocompartmental chondral lesion < 2 cm2, age over 18, and BMI between 18.5 and 30
排除标准
- •previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit > 20° or extension deficit >15°, genu valgum or genu varum > 20°, patients with Hb values < 11 g/dL or platelet < 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.
研究组 & 干预措施
PRP
In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.
干预措施: Bone Marrow Stimulation (Procedure)
PRP
In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection.
干预措施: PRP injection (Drug)
PRP + AD-SVF
In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.
干预措施: Bone Marrow Stimulation (Procedure)
PRP + AD-SVF
In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection.
干预措施: stromal vascular fraction (SVF) (Combination Product)
结局指标
主要结局
Change from baseline in knee clinical function questionnaire (KOOS)
时间窗: From preoperatively (baseline) until the end of the study, up to 60 months.
Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved.
次要结局
- Knee pain assessment(From preoperatively (baseline) until the end of the study, up to 60 months.)
- Adverse events after the procedure(Until the end of the study, up to 60 months.)
- Other Patient-Reported Outcome Measures(From preoperatively (baseline) to the end of the study, up to 60 months.)
研究者
Andrea Vespasiani
MD
Università degli Studi dell'Aquila