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Search / Trial NCT03804853

Rehabilitation Following Reverse Total Shoulder Arthroplasty

Launched by HEALTHPARTNERS INSTITUTE · Jan 11, 2019

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Rehabilitiation Reverse Total Shoulder

ClinConnect Summary

This clinical trial is investigating the best way to help patients recover after a type of shoulder surgery called reverse total shoulder arthroplasty (RTSA). This surgery is often done for issues like severe shoulder arthritis or when other shoulder surgeries haven’t worked. The trial will compare two rehabilitation methods: one where patients start moving their shoulder right after surgery and another more traditional approach that starts movement later. Researchers want to see which method leads to better pain relief, improved movement, and overall recovery within a year.

To participate in this study, you need to be over 55 years old, be scheduled for a primary RTSA, and be able to complete questionnaires in English. You also should be willing to attend all follow-up appointments. However, if you've had previous shoulder surgeries, have certain medical conditions, or are currently using tobacco, you may not be eligible. Participants can expect to be closely monitored throughout the year, and the study aims to improve patient care while also making healthcare more affordable.

Gender

ALL

Eligibility criteria

  • 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).

About Healthpartners Institute

HealthPartners Institute is a leading research organization affiliated with HealthPartners, a prominent not-for-profit healthcare provider in the United States. Dedicated to advancing health outcomes and improving patient care, the Institute conducts innovative clinical trials across various medical disciplines, with a focus on translating research findings into practical applications. By fostering collaboration among healthcare professionals, researchers, and patients, HealthPartners Institute aims to enhance evidence-based practices and contribute to the development of new treatments and interventions that address pressing health challenges.

Locations

Bloomington, Minnesota, United States

Patients applied

SS

1 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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