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临床试验/NCT00894361
NCT00894361终止4 期

A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs

Minneapolis Veterans Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2001年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
发起方
入组人数
400
试验地点
1
主要终点
Knee Postoperative Range of Motion (ROM) at 2 Years

研究概览

简要总结

This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:

  1. Does a RP design offer improvement in range of motion over a AP design?
  2. Does a RP design have improved wear characteristics over a nonmodular AP design?
  3. Is there a clear clinical advantage to the RP design that justifies its increased cost?

Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.

This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.

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
Single (Participant)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •generally accepted clinical and radiographic criteria for primary total knee arthroplasty

排除标准

  • •substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
  • •patients whose mental function precluded them from responding to our standard questionnaires

研究组 & 干预措施

rotating-platform design TKA

Active Comparator

patients who were randomized to receive the rotating platform mobile-bearing TKA design

干预措施: TKA surgery with the rotating platform mobile-bearing knee design (Procedure)

all-polyethylene tibia design TKA

Active Comparator

patients who were randomized to receive the all-polyethylene tibial component design

干预措施: TKA surgery with the all-polyethylene tibia knee design (Procedure)

结局指标

主要结局

Knee Postoperative Range of Motion (ROM) at 2 Years

时间窗: 2 years

range of motion of the knee postoperatively at 2 years

次要结局

  • Survival of the Implants to Subject Death or Implant Removal(10 or more years)

研究者

发起方
Minneapolis Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Terence J. Gioe, M.D.

Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC

Minneapolis Veterans Affairs Medical Center

研究点 (1)

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