Isokinetic Performance and Function Are Similar 12 Months After Total Hip Arthroplasty Applied With a Posterior or Anterolateral Approach: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- isokinetic test
研究概览
简要总结
There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.
详细描述
Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 55 to 80 years unilateral primary hip osteoarthritis -
排除标准
- •bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases
研究组 & 干预措施
anterolateral approach (ALA)
anterolateral surgical approach of total hip arthroplasty
干预措施: hip arthroplasty (Procedure)
posterior approach (PA)
posterior surgical approach of total hip arthroplasty.
干预措施: hip arthroplasty (Procedure)
结局指标
主要结局
isokinetic test
时间窗: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
isokinetic test during flexion, extension and abduction of the hip
次要结局
- Harris Hip Score(Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results)
研究者
Deniz CANKAYA
Assoc. Professor
Gulhane Training and Research Hospital