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临床试验/NCT02079467
NCT02079467Unknown不适用

Unrestricted Rehabilitation Following Primary Total Hip Arthroplasty: Implications for Patient Satisfaction and Functional Performance

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年12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
10
试验地点
1
主要终点
Timed Up and Go (TUG)

研究概览

简要总结

The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.

详细描述

The current standard of care following total hip replacement is to restrict patient activity and range-of-motion with the goal of avoiding dislocation of the operative hip. These restrictions are commonly referred to as "hip precautions". Several recent studies have demonstrated these precautions may be safely abandoned with no increased risk of dislocation when the surgery is carried through an anterior/lateral approach. Previous work has failed to address the issue of patient satisfaction and functional performance when patients are managed with an unrestricted rehabilitation protocol post-operatively. We propose a prospective, randomized clinical trial to determine whether an unrestricted postoperative rehabilitation protocol has an impact on patient satisfaction and functional performance following primary total hip arthroplasty.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • •Age greater than 50 years
  • •Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre

排除标准

  • •Any previous surgery about the ipsilateral hip
  • •Patients being considered for simultaneous bilateral total hip arthroplasty
  • •Patients with a neuromuscular disorder or recognized hypermobility syndrome
  • •Patients without sufficient language skills to communicate in spoken and written English

研究组 & 干预措施

Standard rehabilitation

Active Comparator

Patients randomized to the control group will be managed with "hip precautions" immediately following surgery. They will weight bear on the operative joint as tolerated after surgery. They will be managed as per usual protocol post total hip arthroplasty. They will be transferred from the operative table with an abduction pillow between their legs and will be asked to keep this pillow between their legs while resting in bed and during sleep throughout their course in hospital. During physiotherapy treatments they will not flex the operative hip beyond 90 degrees, internally or externally rotate the operative hip more than 45 degrees, or actively adduct the operative hip past neutral.

干预措施: Standard rehabilitation (Procedure)

Unrestricted rehabilitation

Experimental

Patients randomized to the treatment group will have no restrictions in their post-operative rehabilitation. They will weight bear on the operative joint as tolerated after surgery. They will be asked to participate in activity as their level of comfort permits and will have no positional restrictions while in bed or completing activities of daily living.

干预措施: Unrestricted rehabilitation (Procedure)

结局指标

主要结局

Timed Up and Go (TUG)

时间窗: Six weeks post-operatively

The test involves measuring the duration of time required for a patient to rise from a standard arm chair, walk 3 metres, turn, walk back to the chair, and sit down.

次要结局

  • 4-Item Pain Intensity Measure (P4)(Eighteen weeks post-operatively)
  • Lower extremity functional scale (LEFS)(Eighteen weeks post-operatively)
  • PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing(Eighteen weeks post-operatively)
  • Timed Up and Go (TUG)(Eighteen weeks post-operatively)
  • Six Minute Walk Test (6MWT)(Eighteen weeks post-operatively)
  • 4-Item Pain Intensity Measure (P4)(Baseline)
  • Lower extremity functional scale (LEFS)(Baseline)
  • PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing(Baseline)
  • Timed Up and Go (TUG)(Baseline)
  • Timed Up and Go (TUG)(Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks))
  • Six Minute Walk Test (6MWT)(Baseline)
  • Six Minute Walk Test (6MWT)(Six weeks post-operatively)
  • 4-Item Pain Intensity Measure (P4)(Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks))
  • 4-Item Pain Intensity Measure (P4)(Six weeks post-operatively)
  • Lower extremity functional scale (LEFS)(Six weeks post-operatively)
  • PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing(Six weeks post-operatively)

研究者

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

Dr. Veronica Wadey

Staff surgeon

Sunnybrook Health Sciences Centre

研究点 (1)

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