NCT01308515撤回不适用
A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Objective Knee Score
研究概览
简要总结
The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
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
- None
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
- •are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and 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:
- •Need to obtain pain relief and improve function
- •Ability and willingness of the patient to follow instructions, including control of weight and activity level
- •A good nutritional state of the patient
- •The patient must have reached full skeletal maturity
排除标准
- •will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and 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
研究组 & 干预措施
Posterior Stabilized
Other
Patients who received a PS (Posterior Stabilized) Tibial Bearing.
干预措施: Vanguard Knee System with PS Bearing (Device)
Anterior Stablized
Other
Patients who received an AS (Anterior Stabilized) Tibial Bearing
干预措施: Vanguard Knee System with AS Bearing (Device)
结局指标
主要结局
Objective Knee Score
时间窗: 1 Year Post-op
Average objective knee score; includes a combination of range of motion and pain scores.
次要结局
- Knee Society Score(3 Years)
- Dislocation(3 Years)
- Reports of Radiographic Loosening via Complication Form(3 Years)
- Survivorship(3 Years)
研究者
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