A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Compare Time-saving Associated With the Two Procedures.
研究概览
简要总结
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
详细描述
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
排除标准
- •Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
结局指标
主要结局
Compare Time-saving Associated With the Two Procedures.
时间窗: Day of surgery
Measure clean up time at end of surgery in minutes
Patient OR Time From Both Study Arms
时间窗: Day of surgery
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
次要结局
- Baseline of Hemoglobin Both Study Arms(Baseline, 1 day post-op or at discharge from hospital)
- Baseline of Mechanical Axis Both Study Arms(Baseline, post-operative 6 weeks)
- Related Complications(Baseline, day of surgery, post-op 6 weeks)
- Instrument Trays Sent to Sterilization Both Study Arms(Day of surgery)
- Change From Baseline of Tibial Slope Both Study Arms(Baseline, post-operative 6 weeks)
- Estimated Blood Loss From Both Study Arms(Day of surgery)
- Volume of Transfusions Both Study Arms(Day of surgery)
- Amount of Waste From Surgery Both Study Arms(Day of surgery)