Comparison of Different TKAs Using Objective Dynamic Functional Analysis

Russell Nevins, M.D.1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2020年11月11日最近更新: 2021年8月6日

适应症

干预措施

试验速览

阶段: 不适用
发起方
入组人数: 48
试验地点: 1
主要终点: Force generated by operative extremity - walking up stairs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

详细描述

48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.

The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.

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 (Investigator, Outcomes Assessor)

盲法说明

The patient will be randomized to one of 2 treatment arms using a random number generator. The care provider will not be blinded as he will be implanting the device and following the patients' progress in clinic postoperatively, including radiographs which will show the implants. He will be blinded, however, to the results of the KOOS score and the data derived from the force plate analysis. The research assistants performing those assessments will be blinded to which treatment arm the patient belongs to.

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

•Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
•Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.

排除标准

•Subjects who are unsuitable candidates for the two types of knee implants under investigation.
•Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
•Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
•Subjects who are unwilling to sign Informed Consent/HIPAA documents.
•Subjects who cannot perform the required activities after the surgery.

研究组 & 干预措施

Depuy Attune

Active Comparator

Subjects will have been implanted with the Depuy Attune PCR TKA

干预措施: Depuy Synthes ATTUNE PCR TKA (Device)

MicroPort Medial Pivot

Active Comparator

Subjects will have been implanted with the Microport Evolution Medial Pivot TKA

干预措施: MicroPort Orthopedics EVOLUTION Medial Pivot TKA (Device)