跳至主要内容
临床试验/NCT00979147
NCT00979147终止不适用

A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
400
试验地点
2
主要终点
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)

研究概览

简要总结

This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:

  1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
  2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design?

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

This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.

详细描述

Summary is detailed

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

入选标准

  • generally accepted clinical and radiographic criteria for total knee arthroplasty

排除标准

  • Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
  • Routine contraindications to TKA (active sepsis, Charcot arthropathy)
  • Patients whose mental function preclude them from responding to our standard questionnaires

结局指标

主要结局

Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)

时间窗: 2 year follow-up intervals up to 20 years

Patient recorded outcome measures as noted

次要结局

  • Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene(2 year followup intervals to 20 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 of Orthopaedic Surgery

Minneapolis Veterans Affairs Medical Center

研究点 (2)

Loading locations...

相似试验