Open-Label Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS) in Human Subjects With Medial Unicompartmental Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change from baseline in Knee Society Score (KSS) Objective
研究概览
简要总结
This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
详细描述
The patient-specific Bodycad Unicompartmental Knee System will be implanted on patients with knee osteoarthritis of the medial condyle. The study's hypothesis is that personalized shape and fit of patient-specific knee replacement prosthesis will provide a greater stability and a more natural knee motion in addition to a faster recovery when compared to traditional knee replacement systems. This study is designed to provide a five-years follow-up clinical data on safety and effectiveness of the device.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medial unicompartmental knee osteoarthritic disease diagnosed on the basis of the American College of Rheumatology criterion with radiographic confirmation (Kellgren- Lawrence grade 3 or higher, on a scale of 0 to 4, with higher numbers indicating more severe signs of osteoarthritis); or isolated medial compartment post-traumatic arthritis supported by long film (x-ray);
- •Between the ages of at least 45 years and 70 years (inclusive) at the time of enrollment;
- •Stable health as judged by the Investigator;
- •Willingness to adhere to the protocol requirements as evidenced by the informed consent form duly read, signed and dated by the subject.
排除标准
- •Presence of active or latent infection in the knee;
- •Diagnosis of rheumatoid arthritis or avascular necrosis;
- •Presence of moderate patellofemoral osteoarthritic disease or patellofemoral maltracking;
- •Anterior or posterior translational, varus or valgus ligamentous knee instability and/or deformity;
- •Extension deficit > 15˚ of affected knee;
- •History of ligament surgery on the affected knee, patient that already have a prosthesis on other condyles of the affected knee and/or patient requiring a revision knee replacement surgery;
- •History of proximal tibial fracture, non-union, deformity or oblique joint line;
- •Deficient bone mass that may not provide adequate support and / or fixation;
- •Skeletal immaturity;
- •Obesity: BMI above 35
- •Risk of exposing the prosthesis to overload by the practice of contact or high impact sports such as: baseball, hockey, basketball, football, soccer, karate, skiing etc;
- •Known sensitivity to CoCrMo, Titanium, and polyethylene components of the UKS Prosthesis used in the manufacturing of the prosthesis;
- •Pre-existing medical conditions such as history of cancer other than skin cancer, poorly controlled diabetes, systemic infections, immunocompromised, fibromyalgia or other general body pain conditions, which, in the opinion of the Investigator, interfere with the conduct of the study;
- •Neuromuscular condition that could lead to an unacceptable risk of instability of the prosthesis or other postoperative complications;
- •Subjects, in the opinion of the Investigator, who are unlikely to comply with the protocol (e.g. active alcoholism, drug dependency or psychotic state, unable or unwilling to adhere to study visit schedule);
- •Pregnant or nursing female subjects; or female subjects planning on becoming pregnant within the next 60 months from enrollment;
- •Subjects under guardianship, hospitalized in a public or private institution, for a reason other than research, or subject deprived of freedom;
- •Participation in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
结局指标
主要结局
Change from baseline in Knee Society Score (KSS) Objective
时间窗: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire
次要结局
- Change from baseline of implant position fixation(Post operative week 6, months 6, 12, 24, 36, 48 and 60)
- Change from baseline on bone loss and cementation(Post operative week 6, months 6, 12, 24, 36, 48 and 60)
- Change from baseline in mechanical axis measurement.(Baseline and post operative week 1)