NCT03804853 · HealthPartners Institute
Rehabilitation Following Reverse Total Shoulder Arthroplasty
(RTSA)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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).
Where
- Bloomington, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations