Rehabilitation Following Reverse Total Shoulder Arthroplasty

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    74
  • sponsor
    HealthPartners Institute
Updated on 1 April 2021
pain relief
range of motion
arthropathy
shoulder arthroplasty
rotator cuff tear

Summary

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.

Details
Condition Shoulder Osteoarthritis
Treatment Rehabilitiation
Clinical Study IdentifierNCT03804853
SponsorHealthPartners Institute
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

> 55 years of age
Candidate for a primary reverse total shoulder arthroplasty
Capable of completing self-administered questionnaires
Be willing and able to return for all study-related follow-up procedures
Able and willing to give informed consent
Proficient in the English language

Exclusion Criteria

In-Clinic
Patients planning on undergoing a Primary Reverse Shoulder Total Arthroplasty due to proximal humeral fracture
Previous shoulder surgery including previous total shoulder arthroplasty or reverse total shoulder arthroplasty or hemiarthroplasty, or instability repairs
Active bacterial infection of the shoulder
Any concomitant shoulder procedure
Additional ipsilateral or contralateral upper limb pathology that requires active treatment (i.e. surgery or brace)
Inflammatory arthropathy
Diagnosed with Rheumatoid arthritis
Diagnosed with gout
Subject is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery
Peripheral vascular disease or other vascular disorders that would impair healing
Peripheral neuropathy or other neurological disorders that may impair the patient to ambulate
Patient is on workers compensation
Any condition requiring chemotherapy
Active tobacco user or former tobacco user who is not free of using tobacco for 8 weeks
Uncontrolled Diabetes Mellitus with an HbA1C > 7.5%
Current drug or alcohol abuse
Major medical illness (life expectancy less then 2 years or unacceptably high operative risk)
Suspicion of cervical radiculopathy or myelopathy
Deltoid insufficiency on physical examination
Intra-operative
Iatrogenic glenoid fracture
Post-operative
Neurological injury of the upper extremity
Complications from Primary Reverse Shoulder Total Arthroplasty (i.e. post-operative infection, bleeding, hardware failure)
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