Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 主要终点
- Knee Score at 2 Years Post Operation
研究概览
简要总结
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.
详细描述
Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
- •Stable or reconstructable collateral and posterior cruciate ligaments
- •Correctable deformity
- •Intact quadriceps and hamstrings mechanisms
- •Patella bone thick enough (at least 15 mm) after resection
排除标准
- •Previous TKA
- •Bilateral knee arthritis
- •Non-availability for follow-up
- •Mental incompetence or confinement
- •Patients being treated with other investigational devices for same disorder
- •Infection
- •Osteoporosis, acute renal failure, or other disorders known to affect bone quality
- •Charcot's or Paget's disease
- •Patient physical condition preventing use of appropriate size implant
- •Disease conditions affecting blood supply to knee
- •Insufficient bone quality or quantity
- •Physical condition predisposing implant to extreme loads
- •History of septic knee arthritis
- •History of drug abuse
结局指标
主要结局
Knee Score at 2 Years Post Operation
时间窗: within 2 years
The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) \> 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score \> 80 was used as a criterion to assess "success".
次要结局
未报告次要终点