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Physical Therapy After Reverse Total Shoulder Arthroplasty

2022年1月31日 更新者:Amit Momaya、University of Alabama at Birmingham

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

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.

研究概览

详细说明

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.

These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35205
        • UAB Hospital Highlands

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • • Revision shoulder replacement surgery

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Physical Therapy
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
实验性的:Self-Rehab
This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace.
These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Forward Flexion Range of Motion 1
大体时间:3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
3 months followup

次要结果测量

结果测量
措施说明
大体时间
Strength 1
大体时间:3 months followup
Strength measured using a dynamometer
3 months followup
Simple Shoulder Test Patient Reported Outcome 1
大体时间:3 months followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
3 months followup
Strength 2
大体时间:6 month followup
Strength measured using a dynamometer
6 month followup
Strength 3
大体时间:12 months followup
Strength measured using a dynamometer
12 months followup
Internal Rotation Range of Motion 1
大体时间:3 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
3 months followup
External Rotation Range of Motion 1
大体时间:3 months followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
3 months followup
Internal Rotation Range of Motion 2
大体时间:6 month followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
6 month followup
External Rotation Range of Motion 2
大体时间:6 month followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
6 month followup
Forward Flexion Range of Motion 2
大体时间:6 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
6 months followup
Forward Flexion Range of Motion 3
大体时间:12 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
12 months followup
Internal Rotation Range of Motion 2
大体时间:12 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
12 months followup
External Rotation Range of Motion 2
大体时间:12 months followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
12 months followup
American Shoulder and Elbow Surgeons Shoulder Score 1
大体时间:3 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
3 month followup
Simple Shoulder Test Patient Reported Outcome 2
大体时间:6 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
6 month followup
Simple Shoulder Test Patient Reported Outcome 3
大体时间:12 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 1
大体时间:3 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
3 month followup
American Shoulder and Elbow Surgeons Shoulder Score 2
大体时间:6 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3
大体时间:12 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 2
大体时间:6 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
6 month followup
Single Assessment Numeric Evaluation (SANE) Score 3
大体时间:12 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
12 month followup

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Amit M Momaya, MD、University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年2月27日

初级完成 (实际的)

2022年1月18日

研究完成 (实际的)

2022年1月19日

研究注册日期

首次提交

2018年4月29日

首先提交符合 QC 标准的

2018年6月4日

首次发布 (实际的)

2018年6月6日

研究记录更新

最后更新发布 (实际的)

2022年2月1日

上次提交的符合 QC 标准的更新

2022年1月31日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • F11223344

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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    Instituto de Salud Carlos III
    完全的
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    Novotech
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