A Prospective, Comparative, Randomized, Double Blind, Multi-center Study of the Uniglide™ Mobile Bearing Unicondylar Knee System vs. Uniglide™ Fixed Bearing Unicondylar Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Corin
- 入组人数
- 37
- 试验地点
- 12
- 主要终点
- The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
研究概览
简要总结
The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed Bearing Unicondylar Knee System (control device currently cleared) as measured by the Composite Clinical Success (CCS) endpoint.
详细描述
Arthritic knees are the most common cause of long-term disability resulting in decreased mobility and increased pain. After other treatments for pain relief and return to activities of daily living fail, knee joint replacement is often the best option and unicompartmental knee arthroplasty was introduced as an appropriate treatment for management of osteoarthritis when disease effects only a portion of the knee joint. This study is a prospective, comparative, randomized, double blind (patient and post-operative evaluator), multi-center clinical study under a common protocol to determine the safety and effectiveness of the Uniglide Unicondylar Mobile Bearing knee implant system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature
- •need to obtain pain relief and improved function
- •moderate or severe pain with either walking or at rest on the Hospital for Special Surgery Score
- •preoperative medial tibiofemoral joint space narrowing on x-rays (Kellgren Lawrence grade 3 or 4)
- •preoperative Hospital for Special Surgery Knee Evaluation total score of < 69
- •preoperative arc of motion of > 90o in the affected knee
- •diagnosed with osteoarthritis in the medial compartment of the knee and non-surgical treatment options have failed to provide relief for symptoms
- •able to understand this clinical trial, co-operate with study procedures, and are willing to return to the clinic, and/or hospital for all the required post-operative follow-ups
- •able to give and have given voluntary, written informed patient consent to participate in this clinical investigation and have provided Authorization for Release of Personal Health Information (HIPAA) for the purpose of this clinical study
- •willing to be randomized with either of the devices used in the clinical trial as determined by the randomization schedule
排除标准
- •neurological disorders which may interfere or adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
- •a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms
- •a diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
- •immunologically suppressed
- •on chronic corticosteroid or non-steroidal anti-inflammatory therapy
- •with Charcot's disease
- •with metabolic disorders (e.g. osteomalacia), which may impair bone formation
- •with distant foci of infections, which may spread to the implant site
- •have presence of vascular insufficiency, muscular atrophy and neuromuscular disease
- •have diagnosed osteoporosis as evidenced on a DEXA scan (within the last 12 months)
- •ave diagnosed rheumatoid arthritis or other forms of inflammatory joint disease
- •have diagnosed avascular necrosis
- •with malunion, arthrodesis or severe dysplasia in the affected limb
- •with rapid joint destruction, marked bone loss or bone resorption in the affected knee apparent on x-ray
- •have incomplete or deficient soft tissue surrounding the affected knee
- •have infection, sepsis or osteomyelitis in the affected knee
- •have had revision of previously failed prosthesis, failed upper tibial osteotomy or post traumatic arthritis after tibial plateau fracture in the affected knee
- •with a fixed varus deformity (not passively correctable) of greater than 15 degrees and a flexion deformity greater than 15 degrees in the affected knee
- •with insufficient collateral, anterior or posterior cruciate ligaments in the affected knee, which would preclude stability of the device
- •with disease or damage to the lateral compartment of the affected knee (Outerbridge classification II, III, or IV)
- •with a Body Mass Index > 36
- •with a sensitivity to device material
- •Females who are pregnant
- •prisoners,known drug or alcohol abuser, smoker, or have a psychological disorder
- •Based upon intra-operative assessment, cartilage and bone erosions involving more than the anterior and middle parts of the medial compartment. The posterior part of the medial compartment and the lateral compartment having cartilage of less than normal thickness. (as assessed using the Outerbridge Classification system).
结局指标
主要结局
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
时间窗: Month 24 postoperative
CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines \>1mm in \>50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) \> 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations \> 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery.
次要结局
- Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)(Month 24 postoperative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)(Month 24 postoperative)
- Number of Implants With Any Device-related Complications(Month 24 postoperative)
- The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively(Month 24 postoperative)
- American Knee Society Score (AKSS) (Total, Pain & Function Scores)(Month 24 postoperative)
- Survival Rate Using Kaplan-Meier Survival Curves(Month 24 postoperative)