Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT03804853

Rehabilitation Following Reverse Total Shoulder Arthroplasty

Led by HealthPartners Institute · Updated on 2025-06-05

74

Participants Needed

1

Research Sites

420 weeks

Total Duration

On this page

Sponsors

H

HealthPartners Institute

Lead Sponsor

T

TRIA Orthopaedic Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Reverse total shoulder arthroplasty (RTSA) has been successful in patients with rotator cuff arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA report pain relief and functional range of motion. It has been more than 20 years since the advent of the RTSA construct but an immediate post-operative rehabilitation with active shoulder range of motion has not been prospectively studied in comparison to the traditional post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to prospectively follow our patients following RTSA undergoing an immediate active shoulder rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion. Investigators plan to document clinical outcomes, complications and cost effectiveness out to 1 year. The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the health of the population, improve the experience of each individual, and make healthcare affordable by decreasing the total cost of care.

CONDITIONS

Official Title

Rehabilitation Following Reverse Total Shoulder Arthroplasty

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 55 years of age
  • Candidate for a primary reverse total shoulder arthroplasty
  • Able to complete self-administered questionnaires
  • Willing and able to return for all study follow-up visits
  • Able and willing to provide informed consent
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Undergoing surgery due to proximal humeral fracture
  • Previous shoulder surgery including total shoulder arthroplasty, reverse total shoulder arthroplasty, hemiarthroplasty, or instability repairs
  • Active bacterial infection of the shoulder
  • Any additional shoulder procedure planned
  • Other upper limb conditions requiring active treatment like surgery or bracing
  • Inflammatory arthropathy
  • Diagnosed with rheumatoid arthritis
  • Diagnosed with gout
  • On chronic anticoagulation for bleeding disorders or took anticoagulants within 10 days before surgery
  • Peripheral vascular or neurological disorders affecting healing or walking
  • On workers compensation
  • Any condition requiring chemotherapy
  • Active tobacco use or tobacco use within the last 8 weeks
  • Uncontrolled diabetes with HbA1C above 7.5%
  • Current drug or alcohol abuse
  • Major medical illness with life expectancy under 2 years or high operative risk
  • Suspected cervical radiculopathy or myelopathy
  • Deltoid muscle insufficiency
  • Iatrogenic glenoid fracture during surgery
  • Neurological injury of the upper limb post-surgery
  • Post-operative complications such as infection, bleeding, or hardware failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

TRIA Orthopaedic Center

Bloomington, Minnesota, United States, 55431

Actively Recruiting

Loading map...

Research Team

M

Megan Reams

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here