NCT01301950已完成不适用
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
研究概览
简要总结
This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.
详细描述
The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female and between the ages of 18 and 80 years old, inclusive.
- •Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- •Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
- •Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
- •Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.
排除标准
- •The Subject is a woman who is pregnant or lactating.
- •The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
- •The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
- •The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
- •The Subject requires simultaneous bilateral total knee replacements.
- •The Subject had a contralateral TKA and that knee was previously entered in the study.
- •Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.
- •Subject who has inflammatory arthritis.
- •Subject who has a Body Mass Index (BMI) of ≥
- •(Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).
结局指标
主要结局
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
时间窗: Intraoperative (Time from first incision to first stitch)
Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
次要结局
- Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures(Intraoperative (Total duration of procedure))
- To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location(Intraoperative)
- Turnover Time (Time to Clean Operating Room After Surgery is Completed)(Intraoperative (Time to clean Operating Room after surgery is completed))
- Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete(Intraoperative (Operating Room cleaned up from previous case to surgical draping complete))
研究者
研究点 (6)
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