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临床试验/NCT02458144
NCT02458144Unknown不适用

Comparison of Two Minimally Invasive Approaches to the Hip-anterior Versus Anterolateral - Which Technique is Less Invasive? A Prospective, Randomized, Controlled Pilot Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月1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
40
试验地点
1
主要终点
MRI evaluation

研究概览

简要总结

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.

详细描述

The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur.

Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.

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, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •unilateral, noninflammatory end-stage osteoarthritis of the hip
  • •willingness and ability to cooperate in the required post-operative therapy
  • •willingness and ability to provide written informed consent
  • •age 50-80 years

排除标准

  • •inflammatory arthropathies
  • •prior hip surgery
  • •prior infection of the hip
  • •severe morbidity
  • •severe osteoporosis
  • •inability to tolerate general anesthesia
  • •no contraindications to MRI e.g. pacemakers, claustrophobia
  • •neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care
  • •known alcohol or drug abuse
  • •unwillingness to participate

研究组 & 干预措施

MIS "anterior" group

Other

Total Hip Arthroplasty "anterior" surgical approach

干预措施: Total hip arthroplasty (Procedure)

MIS "anterolateral" group

Other

Total Hip Arthroplasty "anterolateral" surgical approach

干预措施: Total hip arthroplasty (Procedure)

结局指标

主要结局

MRI evaluation

时间窗: 12 months after surgery

Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)

次要结局

  • Serum trauma marker 8(1 hour preop. to 48 hours postop.)
  • Tendon defects of the hip abductors (cm) assessed by Ultrasound(12 months after surgery)
  • Gait analysis(12 months after surgery)
  • Serum trauma marker 1(1 hour preop. to 48 hours postop.)
  • Serum trauma marker 3(1 hour preop. to 48 hours postop.)
  • Serum trauma marker 4(1 hour preop. to 48 hours postop.)
  • Serum trauma marker 5(1 hour preop. to 48 hours postop.)
  • Harris Hip Score(12 months after surgery)
  • Serum trauma marker 2(1 hour preop. to 48 hours postop.)
  • Serum trauma marker 6(1 hour preop. to 48 hours postop.)
  • Serum trauma marker 7(1 hour preop. to 48 hours postop.)

研究者

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

Dr. Christoph Stihsen

Dr. med. univ.

Medical University of Vienna

研究点 (1)

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