Rehabilitation after reverse shoulder surgery

Immediate Accelerated Shoulder Rehabilitation Versus a Standard Protocol Following Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial

This study tests whether starting active shoulder rehabilitation right after reverse shoulder surgery helps people over 55 recover better than traditional rehab methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: HealthPartners Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bloomington, Minnesota)
• Trial ID: NCT03804853 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of immediate active shoulder rehabilitation compared to traditional rehabilitation following reverse total shoulder arthroplasty (RTSA) in patients with shoulder osteoarthritis. Participants aged over 55 who are candidates for RTSA will be randomly assigned to either rehabilitation approach. The study aims to document clinical outcomes, complications, and cost-effectiveness over a one-year period. This research seeks to enhance recovery and functional outcomes for patients undergoing this surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are individuals over 55 years old who are scheduled for primary reverse total shoulder arthroplasty.

Not a fit: Patients with prior shoulder surgeries, active infections, or certain inflammatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery and functional outcomes for patients undergoing reverse total shoulder arthroplasty.

How similar studies have performed: While the concept of immediate rehabilitation post-surgery is not extensively studied, similar approaches in other orthopedic procedures have shown promising results.

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).

Where this trial is running

Bloomington, Minnesota

• TRIA Orthopaedic Center — Bloomington, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Megan Reams

Conditions Shoulder Osteoarthritis; Rehabilitiation; Reverse total shoulder