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临床试验/NCT02268097
NCT02268097Unknown不适用

Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2014年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
101
试验地点
1
主要终点
Patellar tilt (PT)

研究概览

简要总结

The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.

详细描述

With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with <20° varus or <15° valgus deformity patellar thickness is more than 21mm

排除标准

  • •restricted motion (flexion contracture of >25°) patella alta (Insall-Salvati ratio of <0.6) history of previous knee surgery

研究组 & 干预措施

Freehand

Experimental

Patellar resurfacing with freehand technique:Using freehand technique for patella preparation during total knee arthroplasty.

干预措施: Patellar resurfacing with freehand technique (Procedure)

Resection guide

Active Comparator

Patellar resurfacing with resection guide technique: Using patellar resection guide technique for patella preparation during total knee arthroplasty.

干预措施: Patellar resurfacing with resection guide technique (Procedure)

结局指标

主要结局

Patellar tilt (PT)

时间窗: 1 year

The patellar tilt is the angle between the transverse axis of the patella and The patellar tilt is the angle between the transverse axis of the patella and the anterior intercondylar line.The PT was assessed by a blinded observer using 30° skyline radiographs.

次要结局

  • Knee Society Score (KSS)(1 year)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(1 year)
  • visual analogue pain scale (VAS)(1 year)
  • Short Form-36 (SF-36)(1 year)
  • leg alignment(1 year)
  • prosthetic position(1 year)
  • Rang of motion(1 year)
  • patellar displacement (PD)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jia-kuo yu

Peking University Third Hospital

Peking University Third Hospital

研究点 (1)

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