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临床试验/NCT03854357
NCT03854357已完成不适用

The Effect of Focused Rehabilitation on Subscapularis Strength After Total Shoulder Arthroplasty

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年10月2日最近更新:
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
66
试验地点
1
主要终点
Subscapularis Strength

研究概览

简要总结

This is a randomized, double-blinded, standard of care-controlled clinical trial. The purpose of this study is to determine the difference in subscapularis strength and function after anatomic Total Shoulder Arthroplasty (aTSA) in patients who receive isolated subscapularis rehabilitation in addition to the standard rehabilitation after surgery at 12-month follow up. Specifically the investigators will measure subscapularis strength utilizing a dynamometer device and subscapularis function utilizing isolated subscapularis physical examination testing: belly-press, bear-hug, and lift-off tests. Additionally, investigators will document secondary outcome measures including shoulder range of motion and Patient Reported Outcome Measure Information System (PROMIS) questionnaire scores.

详细描述

Study Design: This is a randomized, double-blinded, standard of care-controlled clinical trial. All adult patients undergoing anatomic total shoulder arthroplasty for glenohumeral osteoarthritis will be included and randomized after surgery into either the control group which is prescribed a standard rehabilitation protocol or the intervention group which also is prescribed the same standard rehabilitation protocol with the the addition of isolated subscapularis rehabilitation.

Purpose: To determine the subscapularis strength and function after anatomic total shoulder arthroplasty (aTSA) in patients who receive isolated subscapularis rehabilitation in addition to the standard rehabilitation protocol as compared to those who only receive the standard rehabilitation protocol at 12-month follow up. Specifically the investigators will measure subscapularis strength utilizing a dynamometer and subscapularis function utilizing isolated subscapularis physical examination testing: belly-press, bear-hug, and lift-off tests.

Hypothesis: The investigators believe that subscapularis strength can be improved using isolated subscapularis rehabilitation in addition to standard rehabilitation, leading to improved outcomes in patients receiving aTSA. This should also improve the post-operative physical examination predicting a functional subscapularis tendon.

Rationale and expectations: Anatomic total shoulder arthroplasty is often performed in patients with severe glenohumeral osteoarthritis that have an intact subscapularis. Often times it is seen that these patients return with positive isolated subscapularis tests, despite the subscapularis being intact after surgery. If these patients require revision surgery, an ultrasound is the only test that can be performed to evaluate the status of the subscapularis tendon. This study is difficult and not 100% accurate. It needs to be determined if the patient will need a reverse total shoulder arthroplasty due to the positive subscapularis test findings. Previous studies by Baumgartner et al. showed that patients that received a total shoulder arthroplasty with tenotomy improved liftoff, and bear-hug strength testing, but operative shoulder strength remained inferior to strength of the nonoperative shoulder. Patients with improvements in strength were more likely to have greater improvements in outcome scores and range of motion. It was noted that improvements in the shoulder activity level after anatomic total shoulder arthroplasty may be dependent on improvements in strength. The investigators believe that subscapularis strength can be improved using isolated subscapularis rehabilitation in addition to standard rehabilitation, leading to improved outcomes in patients receiving aTSA. This should also improve the post operative physical examination predicting a functional subscapularis tendon.

Research Plan: Patients to be included in the study will be those with glenohumeral osteoarthritis with an intact rotator cuff that are undergoing anatomic total shoulder arthroplasty. Exclusion criteris includes patients undergoing revision shouder arthroplasty, a previous subscpaularis rotator cuff repair or deficient rotator cuff, patients with inflammatory arthropathies, such as rheumatoid arthritis, and patients with a history of infection in the shoulder joint. Reverse total shoulder arthroplasty will be excluded. Non-English speaking patients will be excluded from the study in order to simplify communication with study participants. The control population will consist of patients undergoing the standard rehabilitation protocol for aTSA. Patients will be undergoing rehabilitation regardless of study participation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •All adult patients over the age of 18
  • •Must have a diagnosis of glenohumeral osteoarthritis
  • •Must be scheduled for primary anatomic total shoulder arthroplasty.

排除标准

  • •History of prior rotator cuff surgery
  • •Rotator cuff deficiency
  • •Planned reverse total shoulder arthroplasty
  • •inflammatory arthropathy
  • •prior shoulder replacement surgery
  • •neurologic deficits of the affected extremity
  • •diagnosis of frozen shoulder
  • •previous infection in the shoulder.

研究组 & 干预措施

Additional Isolated Subscapularis Rehabilitation

Experimental

Patients will be randomized to receive additional isolated subscapularis specific rehabilitation exercises during their standard post-operative physical therapy sessions after anatomic total shoulder arthroplasty.

干预措施: Subscapularis Rehabilitation (Procedure)

Additional Isolated Subscapularis Rehabilitation

Experimental

Patients will be randomized to receive additional isolated subscapularis specific rehabilitation exercises during their standard post-operative physical therapy sessions after anatomic total shoulder arthroplasty.

干预措施: Standard Rehabilitation (Procedure)

Standard Post-Operative TSA Rehabilitation

Active Comparator

Patients will be randomized to receive additional isolated subscapularis specific rehabilitation exercises during their standard post-operative physical therapy sessions after anatomic total shoulder arthroplasty.

干预措施: Standard Rehabilitation (Procedure)

结局指标

主要结局

Subscapularis Strength

时间窗: 12 months post-operative follow-up

Subscapularis strength is the single, primary outcome measure. It will be measured by a dynamometer device, which is a device that patient holds in their hand and presses against a static object (such as a wall), creating force which is measured by the device. The device records this force as pounds (lb). Therefore, the investigators will use the dynamometer device to measure the single, primary outcome measure of strength (of the subscapularis muscle), with the single output unit of "pounds of force" in order to measure changes in strength from pre-operative testing to post-operative testing (at 3, 6, and 12 month post-operative time points).

次要结局

  • Shoulder Range of Motion(12 months post-operative follow-up)
  • Patient Reported Outcome Measure Information System(12 months post-operative follow-up)
  • Subscapularis Function(12 months post-operative follow up.)

研究者

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

Lafi Khalil

Principal Investigator

Henry Ford Health System

研究点 (1)

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