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临床试验/NCT03547726
NCT03547726已完成不适用

Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Forward Flexion Range of Motion 1

研究概览

简要总结

A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

详细描述

A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.

There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.

Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.

Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.

The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.

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
Double (Care Provider, Investigator)

盲法说明

The physician will not know if the patient is receiving at home physical therapy or seeing a physical therapist in clinic.

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

  • • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons

排除标准

  • • Revision shoulder replacement surgery
  • Mentally incompetent to provide informed consent
  • Non-english speaking
  • Minors (<18)
  • Pregnant women
  • Prison population
  • Acute Shoulder Fractures

结局指标

主要结局

Forward Flexion Range of Motion 1

时间窗: 3 months followup

Active range of motion in the shoulder joint in forward flexion (measured in degrees)

次要结局

  • Internal Rotation Range of Motion 1(3 months followup)
  • External Rotation Range of Motion 2(12 months followup)
  • Forward Flexion Range of Motion 3(12 months followup)
  • Strength 1(3 months followup)
  • Simple Shoulder Test Patient Reported Outcome 1(3 months followup)
  • Strength 3(12 months followup)
  • External Rotation Range of Motion 1(3 months followup)
  • Simple Shoulder Test Patient Reported Outcome 3(12 month followup)
  • American Shoulder and Elbow Surgeons Shoulder Score 3(12 month followup)
  • Single Assessment Numeric Evaluation (SANE) Score 2(6 month followup)
  • Strength 2(6 month followup)
  • Internal Rotation Range of Motion 2(12 months followup)
  • American Shoulder and Elbow Surgeons Shoulder Score 1(3 month followup)
  • Simple Shoulder Test Patient Reported Outcome 2(6 month followup)
  • Single Assessment Numeric Evaluation (SANE) Score 1(3 month followup)
  • American Shoulder and Elbow Surgeons Shoulder Score 2(6 month followup)
  • Forward Flexion Range of Motion 2(6 months followup)
  • Single Assessment Numeric Evaluation (SANE) Score 3(12 month followup)

研究者

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

Amit Momaya

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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