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临床试验/NCT02883998
NCT02883998已完成不适用

Formal vs. Home-Based Physical Therapy After Unicompartmental Knee

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

研究概览

简要总结

To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).

详细描述

Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.

A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)

Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.

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
None

入排标准

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

入选标准

  • Scheduled for a unicompartmental knee arthroplasty

排除标准

  • Require inpatient physical therapy beyond post-operative day one
  • < 18 years old
  • Decline to participate

研究组 & 干预措施

Outpatient Physical Therapy Group

Active Comparator

Once the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks.

干预措施: Outpatient Physical Therapy (Other)

Home Base Physical Therapy Group

Experimental

Patients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises.

干预措施: Home Base Physical Therapy (Other)

结局指标

主要结局

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

时间窗: at 3 weeks, 3 months, and 1 year after surgery

Change from baseline in Knee Society Score

时间窗: at 3 weeks, 3 months, and 1 year after surgery

Change from baseline in Knee range of motion

时间窗: at 3 weeks, 3 months, and 1 year after surgery

次要结局

  • Complications(Will be assessed at 3 weeks, 3 months, and 1 year after surgery)
  • Cost comparison(Will be assessed at 3 weeks, 3 months, and 1 year after surgery)

研究者

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

Craig J Della Valle, MD

MD

Rush University Medical Center

研究点 (2)

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