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临床试验/NCT01959360
NCT01959360已完成不适用

Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Implant stability

研究概览

简要总结

The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.

The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by two minimal invasive/incision surgeries (MIS) versus the traditionally lateral approach.

The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after MIS than after traditional lateral surgery. Patients in the MIS group will also be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.

详细描述

With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant. When the lateral surgical approach is used, major concerns after total hip replacement surgery are muscle abductor weakness/atrophy, tendon defects of the gluteus minimus muscle, and unsuccessful reattachment or denervation of the anterior gluteal flap.

Minimal incision/invasive surgery (MIS) is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for THA
  • Diagnosis of primary osteoarthritis as the main cause for elective THA
  • American Society of Anesthesiologists (ASA) score I, II, and stable III

排除标准

  • Musculoskeletal diseases
  • Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.

研究组 & 干预措施

direct lateral

Active Comparator

干预措施: Direct lateral (Procedure)

minimal invasive

Experimental

干预措施: minimal invasive (Procedure)

modified minimal invasive

Experimental

干预措施: modified minimal invasive (Procedure)

结局指标

主要结局

Implant stability

时间窗: 2 years

次要结局

  • Implant stability(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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