Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS) subscale Pain postoperative improvement
研究概览
简要总结
The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clinical analysis of the treatment outcomes, regarding postoperative improvements and safety, is going to be accompanied with laboratory analysis of the intraoperatively applied cellular products.
The main hypothesis are: (1) such combined single-step procedure significantly improves patients' functioning and quality of life; (2) this therapeutic approach is safe; (3) cellular parameters of the applied filtered bone marrow aspirate (fBMA) impact treatment outcomes, among other potential predictors.
Researchers will compare subjective (questionnaire) and objective (clinical examination) status of patients before and after the operation, record any potential complications and perform regression analysis to assess the influence of potential predictors on postoperative improvements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •informed consent
- •patients treated with combined single-step procedure (scaffold and fBMA) for knee articular surface lesions, between January 2013 and December 2020
- •symptomatic knee articular surface lesions (International cartilage repair society (ICRS) grades 3-4, size ≥ 1.5 cm2) unresponsive to conservative treatment,
- •only mild concomitant osteoarthritis (Kellgren-Lawrence grades 1-2)
排除标准
- •patients that refuse to participate in the study
- •non responders to the invitation to answer PROMs at the follow-up
- •associated medical conditions (inflammatory, metabolic, neoplastic, etc.) that could directly handicap the musculoskeletal system or indirectly impact the quality of life
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale Pain postoperative improvement
时间窗: At least 24 months after the operation
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patients' pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score 0 being the worst score and 100 indicating no impairment. KOOS subscale Pain postoperative improvement will be calculated as difference between preoperative and postoperative scores at the final follow up. Paired Student t test will be applied to compare preoperative and postoperative values of KOOS subscale Pain.
次要结局
- Tegner Activity Scale (TAS) postoperative improvement(At least 24 months after the operation)
- Knee injury and Osteoarthritis Outcome Score (KOOS) subscales postoperative improvements(At least 24 months after the operation)
- Complications (SAE and GF)(Recording until the final follow up (minimum 24 months after the operation))
- Potential predictors (patients' demographics, medical history, joint and lesions' characteristics, surgical and cellular parameters) of the clinical outcomes (KOOS subscales, EQ-5D-3L, EQ-VAS, TAS)(At the time of statistical analysis)
- Cellular parameters of intraoperatively applied filtered Bone Marrow Aspirate (fBMA)(Finsihed in 14 days after the procedure)
- European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) postoperative improvement(At least 24 months after the operation)
- EuroQol Visual Analogue Scale (EQ-VAS) postoperative improvement(At least 24 months after the operation)