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临床试验/NCT01160835
NCT01160835已完成4 期

Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
To compare the clinic and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach

研究概览

简要总结

Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting instruments has been proposed to limit surgical dissection without compromising the surgical outcome. We conducted a prospective, randomized study to compare the outcomes of quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.

We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps muscle strength, alignment of the prosthetic knee, and clinical outcome.

详细描述

Eighty primary TKAs in sixty patients of osteoarthritis constituted this study. Patients were randomly assigned to either quadriceps-sparing (QS, 40 knees) or medial parapatellar (MP, 40 knees) group. All surgeries were designed to set the prosthesis with thefemoral component alignment of 7º valgus and the tibial component alignment perpendicular to tibial shaft. Outcome variables included knee function defined by Hospital for Special Surgery knee score, quadriceps muscle strength measured by isokinetic dynamometer, pain indicated on visual analogue scale, range of motion, and post-operative alignment measured on plain radiograph.

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
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • advanced osteoarthritis with radiograph-evident narrowing of joint gap,
  • with persistent symptoms after conservative treatment for at least 6 months, and
  • patients' intention to receive the prosthetic TKA.

排除标准

  • the knees with excessive deformity of femorotibial angle exceeding 15° varus or 10° valgus,
  • flexion contracture exceeding 15°,
  • active infection involving the knees, or
  • knees received previous surgery.

结局指标

主要结局

To compare the clinic and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach

时间窗: 2 years

Perioperative parameters: operative time, blood loss, Doses of narcotics for pain control, peri-operative complications Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment, complications

次要结局

  • To compare the survival and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach at 2-year follow-up.(5 and 10 years)

研究者

申办方类型
Other

研究点 (1)

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