Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- IKDC-Subjective Score
研究概览
简要总结
The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The evaluation will be performed through clinical, subjective and objective assessments.
详细描述
30 patients affected by OCD of the knee will be included in observational, perspective, monocentric trial. Patients will undergo clinical follow-up visits and administration of questionnaires before surgery and at 6, 12, 24 and 60 months after surgery. A CRF (Case Report Form) related to the patient's specific evaluation will be completed for each visit. Patients will also have imaging (MRI) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. Evaluation of the quality of cartilage repair will be assessed by specific MRI radiographic scores.
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
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •-Additional grade III or IV cartilage injury on the knee being treated;
- •Advanced osteoarthritis
- •Systemic or localized infection
- •Systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases
- •Immune system disorders
- •Degenerative or vascular bone pathology (e.g. osteonecrosis)
- •Coagulation disorders
- •Systemic conditions that alter wound healing
- •Established allergy to equine collagen and calcium phosphate salts
- •Presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously;
- •Previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months;
- •Presence of any known human immunodeficiency virus, hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; Uncontrolled diabetes; Uncontrolled thyroid function changes; Uncontrolled metabolic disorders; Renal disease and hypercalcemia
- •Uncooperative patients, including those with a history of alcohol and drug abuse; Participation in another clinical trial or medical device trial that clinically interferes with the present pilot study;
- •Incapacitated patients;
- •Pregnant or lactating women. In particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hCG).
结局指标
主要结局
IKDC-Subjective Score
时间窗: 24 months
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function
次要结局
- IKDC-Subjective Score(baseline, 6 months, 12 months, 60 months)
- IKDC-Objective Score(baseline, 6 months, 12 months, 24 months, 60 months)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 6 months, 12 months, 24 months, 60 months)
- TegnerActivity Level Scale(baseline, 6 months, 12 months, 24 months, 60 months)
- Patient Acceptable Symptom State (PASS(baseline, 6 months, 12 months, 24 months, 60 months)
- KOOS Score(baseline, 6 months, 12 months, 24 months, 60 months)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score(12 months, 24 months, 60 months)