跳至主要内容
临床试验/NCT02178020
NCT02178020Unknown不适用

Prospective, Randomized Study of Highly-cross Linked Polyethylene vs. Compression Molded Polyethylene for Primary Posterior-stabilized Total Knee Arthroplasty

Chapel Hill Orthopedics Surgery & Sports Medicine1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Number of Participants requiring revision, or with Device Related Serious Adverse Events

研究概览

简要总结

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

详细描述

This prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. Intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE tibial insert. Both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. Postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained at each visit. Clinical data forms will be completed at each visit. At the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients indicated for primary total posterior stabilized knee arthroplasty

排除标准

  • patients who refused participation
  • patients who did not comprehend the English language to give informed consent
  • patients with severe knee deformity thought to require a primary constrained condylar prosthesis

结局指标

主要结局

Number of Participants requiring revision, or with Device Related Serious Adverse Events

时间窗: Up to 10 years

reoperation rate; polyethylene fracture/failure rate

Radiographic osteolysis

时间窗: up to 10 years

lucent, periarticular lesions , related to polyethylene wear

次要结局

  • knee joint effusion(up to 10 years)
  • knee scores(up to 10 years)

研究者

发起方
Chapel Hill Orthopedics Surgery & Sports Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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