NCT02350049已完成不适用
Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 391
- 主要终点
- Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.
详细描述
The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee
- •signed informed consent for patients contributing to investigational or control if required
- •Male or female over the age of 21 years at the time of surgery
- •Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- •Patients that are current residents of the United Kingdom
排除标准
- •Evidence of infection, sepsis, and osteomyelitis at the time of surgery
- •Use in the lateral compartment of the knee
- •Rheumatoid arthritis or other forms of inflammatory joint disease
- •Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- •Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
- •Partial or full thickness cartilage disease or damage to central part of the lateral femoral condyle
- •Osteoporosis or insufficient bone stock
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infection which may spread to the implant site
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, neuromuscular disease
- •Incomplete or deficient soft tissue surrounding the knee
- •Charcot's disease
- •A fixed varus deformity (not passively correctable) of greater than 15 degrees
- •A flexion deformity greater than 15 degrees
- •Refuse to sign informed consent if it is required
- •Patients that are not current residents of the United Kingdom
结局指标
主要结局
Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)
时间窗: 22+months
Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects
次要结局
- Survivorship (Cementless Only)(22+ Months)
- Oxford Knee Score(0-16 Weeks, 6 Months, 12 Months, 22+ Months)
- American Knee Society Score(0-16 Week, 6 Month, 12 Month)
- Adverse Events(Through 22+ Months Postop)
研究者
相似试验
撤回
不适用
Prospective Data Collection on Cementless Oxford Partial KneeArthroplasty, Replacement, KneeNCT00760188Zimmer Biomet
进行中（未招募）
不适用
Prospective Randomized Study of Cementless vs Cemented UKAOsteoarthritis, KneeNCT05377450JIS Research Institute108
Enrolling By Invitation
不适用
Cemented vs. Cementless Unicompartmental Knee ArthroplastyPartial Knee ReplacementNCT05616884Anderson Orthopaedic Research Institute100
终止
不适用
Observational Study to Evaluate Clinical Performance and Safety in Total Knee ArthroplastyTotal Knee ArthroplastyKnee DiseaseTotal Knee ReplacementOsteo Arthritis KneeNCT04872855Corin163
进行中（未招募）
不适用
Comparison of the in Vivo Stability of 2 Cementless TKA DesignsKnee OsteoarthritisNCT05651009Helse Møre og Romsdal HF50