Randomized Controlled Trial of Home-based Physical Therapy Versus Outpatient Clinic-based Physical Therapy Following Primary Anterior Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in SF-12v2 Scores
研究概览
简要总结
130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the other study group at their 6-week follow-up visit.
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 (Investigator)
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
- 否
入选标准
- •scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator
- •available for follow ups postoperatively
排除标准
- •Age <18 or > 75
- •Preoperative BMI ≥ 40
- •Revision (i.e., non-primary) THA procedures
- •Patients who have undergone THA in contralateral hip within the past 6 months
- •Patient is scheduled for or anticipating THA on contralateral limb within 6 months
- •Patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication)
- •Current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation
- •Cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- •History of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint
- •History of significant neurological and/or musculoskeletal disorders that may adversely affect gait after THA
- •History of inflammatory hip arthritis
- •History of septic hip arthritis in affected hip
- •Patients requiring discharge to a rehabilitation center, skilled nursing facility, long-term care center, or convalescent home
- •Non-English speaking
- •Unable to give informed consent
- •Currently enrolled in another therapeutic study for THA
研究组 & 干预措施
Clinic-based Physical Therapy
干预措施: total hip arthroplasty (Procedure)
Home-based Physical Therapy
干预措施: total hip arthroplasty (Procedure)
结局指标
主要结局
Change in SF-12v2 Scores
时间窗: preoperative and postoperative 24 weeks
Change in Hip Disability and Osteoarthritis Outcome Scores
时间窗: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
次要结局
未报告次要终点
研究者
Thomas J Ellis
Principal Investigator
Orthopedic One