Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 6
- 主要终点
- OR time
研究概览
简要总结
Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.
详细描述
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.
For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.
A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- •Informed Consent: Patient has signed a "Patient Informed Consent.
- •Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- •Able and willing to follow instructions and complete follow-up
- •Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
排除标准
- •Patient is skeletally immature
- •Active Infection (including septic knee, distant infection, or osteomyelitis)
- •Severe hip arthrosis
- •Neurological disorders (including, but not limited to Parkinson's disease)
- •Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- •Hip or knee ankylosis
- •Either rheumatoid or post-traumatic knee arthritis
- •Scheduled for simultaneous bilateral TKA
- •Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
- •Any metal within 150 mm of the joint line for the operative-side knee
- •Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- •An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
- •A female who is pregnant or lactating
- •Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- •Arterial disease or stents that would exclude the use of a tourniquet
研究组 & 干预措施
PSI
Patients received TKA using patient-specific Instrumentation.
干预措施: PSI (Procedure)
Conventional
Patients received TKA conventional Instrumentation.
干预措施: Conventional (Procedure)
结局指标
主要结局
OR time
时间窗: during surgery
Operating Room (OR) time: incision to Close in minutes
次要结局
- OR resource use: number of instrument trays(during surgery)
- EQ-5D-3L(1 year after surgery)
- device alignment(1 year after surgery)
- OR Setup Time(during surgery)
- Oxford Knee Score(1 year after surgery)
- visual analog scale (VAS)(1 year after surgery)