All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in knee functionality assessed by KOOS
研究概览
简要总结
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
详细描述
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cartilage tissue and clinical results with regard to pain and function of the treated knee.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
- •Lesion between 1 and 8 cm2;
- •BMI ≤ 34;
- •Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
排除标准
- •Previous cartilage operation on the injured knee
- •Additional grade III or IV lesion on the same knee
- •Previous arthroscopic treatments that affect the AACR technique
- •Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
- •Previous tendon repair, ligament reconstruction or realignment within the last 6 months
- •Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
- •Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
- •Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
- •Inability to follow procedures (i.e. dementia)
- •Inability to give consent
- •No understanding of German language
- •Pregnant or lactating women
结局指标
主要结局
Change in knee functionality assessed by KOOS
时间窗: (before treatment, 6, 12 and 24 months postoperative
The primary clinical outcome is the change in knee functionality assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire over 2 years (before treatment, at baseline, versus 6, 12 and 24 months postoperative). The KOOS is a Patient Reported Outcome Measure (PROM) designed to asses patient-relevant outcomes following knee injury. It is a self-completion questionnaire with a 1-week-recall-period with 42 items and 5 subscales (pain, symptoms, activities of daily life, sport and leisure, quality of life associated with the knee joint). Each question has five answering options, scored with a numerical value of 0 - 4. In average, it takes 10 minutes to complete. The calculation of the respective sub-score is done by adding up the marked items of the relevant subscales. These numerical values are then converted into a scale value between 0 (extreme knee problems) and 100 (free of knee joint complaints).
次要结局
- Quality of cartilage repair tissue MRI evaluation(12 and 24 months)
- Numeric Rating Scale (NRS) for pain(Baseline, 6, 12 and 24 months)
- Difference between baseline and follow-up visits of the physical examination(Baseline, 6, 12 and 24 months)
- Marx activity rating scale (MARS)(Baseline, 6, 12 and 24 months)
- Baseline quality of cartilage repair tissue MRI evaluation(baseline)