Subscapularis Strength After Total Shoulder Arthroplasty

NCT03854357 | Completed DMC

• 1 other identifier: 12088
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Osteoarthritis

Keywords

Subscapularis; Total Shoulder Arthroplasty; Subscapularis Rehabilitation; Subscapularis strength

Outcome Measures

Primary Outcomes (1)

• Subscapularis Strength

  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).

  12 months post-operative follow-up

Secondary Outcomes (3)

• 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.

Study Arms (2)

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.

Procedure: Subscapularis Rehabilitation; Procedure: Standard Rehabilitation

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.

Procedure: Standard Rehabilitation

Interventions

Subscapularis Rehabilitation PROCEDURE

Specific subscapularis rehabilitation exercises which are not included in the current, standard rehabilitation protocol assigned to total shoulder arthroplasty patients post-operatively.

Additional Isolated Subscapularis Rehabilitation

Standard Rehabilitation PROCEDURE

Standard post-operative rehabiliation protocol assigned to all total shoulder arthroplasty patients postoperatively

Additional Isolated Subscapularis Rehabilitation; Standard Post-Operative TSA Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Study Officials

• Lafi S Khalil, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 26, 2019
• Study Start: October 2, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

US (1)