Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Knee Society Passive Flexion at 6 Months
研究概览
简要总结
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.
详细描述
The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Inflammatory Arthritis
- •Age = 40-70 years
- •Male or female
- •Suitable for devices in study
- •Needing primary simultaneous bilateral knee replacements
- •Willing to consent and authorize release of personal health information
- •Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,
排除标准
- •Existing conditions that would compromise participation
- •Multiple joint involvement
- •Pregnant/lactating women
- •Inflammatory arthritis
- •Fixed flexion contracture greater than 20 degrees
- •Previous knee replacement of any type
- •Needing device(s) not specified in protocol
- •The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
- •Those who have participated in an investigation in the last 3 months
- •Those involved in personal injury litigation, medical-legal or workers compensation claims
- •Failure to follow surgical technique details specified in the protocol
研究组 & 干预措施
PFC Sigma RP
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.
干预措施: Total knee replacement using the PFC Sigma RP knee implant (Device)
PFC Sigma RP-F
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
干预措施: Total knee replacement using the PFC Sigma RPF knee implant. (Device)
结局指标
主要结局
Knee Society Passive Flexion at 6 Months
时间窗: 6 months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
次要结局
- Patient Specific Anthropometrics(Collected at pre-op)
- Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee(Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months)
- Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs(Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months)
- Single Leg Active Flexion (SLAF)(Pre-op, 6- and 12-months)
- American Knee Society (AKS) Score(Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval)
- KOOS Pain Sub-score(Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up)
- Patellar Crepitus Defined as No Crepitus, FINE or COARSE(Collected at Pre-operative, 6 weeks and 6 and 12 months)
- Subject Satisfaction(Collected pre-and post-op, reported at 12-months)