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临床试验/NCT01636375
NCT01636375已完成不适用

The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches

Northwell Health1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Change from baseline in muscle volume at 6 weeks

研究概览

简要总结

This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. Second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. Third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups.

The investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. The investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. The investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective, primary total hip arthroplasty
  • Use of Cementless Total Hip components
  • Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis

排除标准

  • Prior surgery on the affected hip
  • No implanted medical devices or metallic debris in the patient which will preclude use of MRI
  • patients must be able to participate in standard post-arthroplasty rehabilitation protocols.

结局指标

主要结局

Change from baseline in muscle volume at 6 weeks

时间窗: 6 weeks after surgery

Muscle volume will be recorded in MRI images with specialized software (external rotators,tensor fascia lata, rectus femoris,gluteus medius and minimus)

Change from baseline in muscle volume at 6 months

时间窗: 6 months after surgery

次要结局

  • tendon damage(6 weeks after surgery)
  • Change in Fatty atrophy of muscles from baseline at 6weeks(6 weeks after surgery)
  • Change in fatty atrophy of muscles from baseline at 6 months(6 months after surgery)
  • Tendon damage(6 months after surgery)

研究者

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

Jose Rodriguez, MD

MD, Director, Center For Joint Preservation & Reconstruction,NorthShoreLIJ/LenoxHill Hospital

Northwell Health

研究点 (1)

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