NCT00859963已完成不适用
Regenerex Tibial Tray Multi-Center Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.
详细描述
See Protocol
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K
- •These indications are stated below:
- •Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- •Correction of varus, valgus, or posttraumatic deformity.
- •Correction or revision of unsuccessful osteotomy, or arthrodesis.
- •Patient selection factors to be considered include:
- •Ability and willingness of the patient to follow instructions, including control of weight and activity level
- •A good nutritional state of the patient, and
- •The patient must have reached full skeletal maturity
排除标准
- •The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K
- •These contraindications are stated below:
- •Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
- •Relative contraindications include:
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •Osteoporosis,
- •Metabolic disorders which may impair bone formation,
- •Osteomalacia,
- •Distant foci of infections 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.
结局指标
主要结局
Knee Society Score
时间窗: 5 years
次要结局
- Survivorship(5 years/ patient)
研究者
研究点 (6)
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