Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
详细描述
The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 30 ≤ 65 years
- •Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage defects > 50% of the cartilage depth) or grade 4 (severely abnormal, through the cartilage depth) on medial or lateral femoral condyles
- •Cartilage lesion area < 3.2 cm2 (diameter < 2 cm)
- •Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture
- •VAS-pain symptom >40 for more than 6 months
- •The arthroscopic finding corresponds to the expected; size of cartilage lesion is correct and no other significant pathology (see CIP, "Intra-operative check-list", Appendix I)
- •Capable of completing self-administered questionnaires
- •Willing to comply with the follow-up requirements of the study
- •Signed informed consent
排除标准
- •BMI ≥ 35 kg/m2 (severe obesity)
- •Instability or deficiency of soft tissues, vascular or muscular insufficiency
- •Metabolic disorders which may impair bone formation
- •Diabetes mellitus
- •Diagnosis of a concomitant knee injury which the Investigator appreciates may interfere with study participation (i.e. may confound efficacy assessment or healing at the involved knee joint level)
- •Irresolvable joint pain or loss-of-function with an undeterminable cause
- •Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention
- •Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5))
- •Avascular necrosis
- •Infections, systemic or local
- •Known metal allergies
- •History of inflammatory arthritis
- •Pacemaker implant
- •History of drug or substance abuse
- •Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents
- •Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study.
- •Condition that may have an impact on the outcome of the investigation as judged by the Investigator.
结局指标
主要结局
Number of participants with Adverse Events
时间窗: 24 months
The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05
次要结局
- Clinical performance(24 months)