NCT00175448已完成不适用
A Randomized Controlled Trial of Outpatient Physiotherapy Versus a Self-Administered Home Exercise Program Following Discharge Home From Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).
研究概览
简要总结
A Randomized Controlled Trial of Outpatient Physiotherapy versus a Self-Administered Home Exercise Program Following Discharge Home from Total Hip Arthroplasty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •primary THA (cemented or cementless)
- •preoperative diagnosis of osteoarthritis (primary or secondary)
- •meets objective discharge-to-home test following hip replacement
- •ability to speak English and reply to questionnaires written in English
- •ability to provide informed consent
- •may include patients presenting for their second primary hip arthroplasty
- •Discharge to Home Criteria
- •independent supine-to-sit transfer
- •independent sit-to-stand transfer
- •walk with walking aid 30 meters
- •ascend and descend 3 stairs
- •deemed medically fit and safe for home environment by surgeon/nursing/PT
排除标准
- •surgery as part of a workers' compensation claim
- •arthroplasty performed for trauma or following open reduction and internal fixation, malignancy or inflammatory arthropathy
- •intra-operative complication of fracture or sciatic nerve injury
- •procedure requiring complex surgical approach other than posterior or anterolateral (ie trochanteric osteotomy/micro 2 incision approach)
- •indications for additional primary or revision arthroplasty within the time frame of the study (24 months) in other hip or knee joints which would adversely affect quality of life and functional scores pertaining to the joint of interest
结局指标
主要结局
Physical function at 16 weeks post THA in patients who received outpatient physiotherapy following discharge home compared to unsupervised self- directed exercises alone (as measured by the WOMAC).
时间窗: 16 weeks
次要结局
- Does outpatient physiotherapy result in superior outcomes (final outcome) at 1 and 2 years post THA?(2 years)
- Does outpatient physiotherapy, compared to a self-directed exercise program, result in greater improvement in:
- generic health-related QOL (SF-36) and (HUI3)
- pain and stiffness (WOMAC pain and stiffness)
- activities of daily living (FSI)
- patient satisfaction (Brigham and Women's patient satisfaction)
- objective physical function (TUG, Harris Hip, Gait Lab)
- What is the marginal cost effectiveness of outpatient physiotherapy versus self-directed exercises?
- How does the recovery over time compare between programs (trajectory of recovery) ?
- What is the difference in musculoskeletal adverse event rate (ie dislocation)?
研究者
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