Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Implant migration
研究概览
简要总结
There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health.
Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis of the knee indicating surgical intervention
- •Between the ages of 21 and 80 inclusive
- •Ability to give informed consent
排除标准
- •Significant co-morbidity affecting ability to ambulate
- •Flexion contracture greater than 15°
- •Extension lag greater than 10°
- •Tibial subluxation greater than 10 mm on standing AP radiograph
- •Prior arthroplasty, patellectomy or osteotomy with the affected knee
- •Lateral or medial collateral ligament instability (> 10° varus/valgus)
- •Leg length discrepancy greater than 10 mm
- •Bone quality precluding uncemented fixation
- •Active or prior infection
- •Morbid Obesity (BMI > 40)
- •Medical condition precluding major surgery
- •Severe osteoporosis or osteopenia
- •Neuromuscular impairment
研究组 & 干预措施
New saw blade
New saw blade
干预措施: New saw blade (Procedure)
Reprocessed saw blade
Reprocessed saw blade
干预措施: Reprocessed saw blade (Procedure)
结局指标
主要结局
Implant migration
时间窗: 2 years
Implant migration assessed with RSA
次要结局
- Economics(1 year)
研究者
Glen Richardson
MD FRCPC
Nova Scotia Health Authority
