Physical Therapy After Reverse Total Shoulder Arthroplasty

NCT03547726 | Completed

• 1 other identifier: F11223344
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Forward Flexion Range of Motion 1

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

  3 months followup

Secondary Outcomes (20)

• Strength 1

  3 months followup

• Simple Shoulder Test Patient Reported Outcome 1

  3 months followup

• Strength 2

  6 month followup

• Strength 3

  12 months followup

• Internal Rotation Range of Motion 1

  3 months followup

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR

This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.

Other: Physical Therapy

Self-Rehab

EXPERIMENTAL

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.

Other: Self-Rehab

Interventions

Physical Therapy OTHER

These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.

Physical Therapy

Self-Rehab OTHER

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.

Self-Rehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Amit M Momaya, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The physician will not know if the patient is receiving at home physical therapy or seeing a physical therapist in clinic.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be two groups of patients randomized either to receive formal physical therapy in clinic or a self-led at home rehabilitation regimen.

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: June 6, 2018
• Study Start: February 27, 2019
• Primary Completion: January 18, 2022
• Study Completion: January 19, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

US (1)