RecruitingNot ApplicableNCT03804853

Rehabilitation Following Reverse Total Shoulder Arthroplasty

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


Sponsor

HealthPartners Institute

Enrollment

74 participants

Start Date

Dec 12, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study compares different rehabilitation approaches after reverse total shoulder arthroplasty (rTSA) — a type of shoulder replacement surgery used for patients with severe rotator cuff tears, shoulder arthritis, or fractures. In a reverse shoulder replacement, the ball and socket are 'reversed' compared to normal anatomy, which allows the deltoid muscle (rather than the rotator cuff) to power arm movement. After surgery, patients undergo a rehabilitation program, but the optimal approach and timing are not well established. The study follows patients for at least one year, tracking their shoulder strength, range of motion, pain, and quality of life under different rehabilitation protocols. You may be eligible if: - You are over 55 years old - You are scheduled for a primary reverse total shoulder arthroplasty - You are able to complete questionnaires and attend follow-up visits - You speak and read English proficiently You may NOT be eligible if: - Your surgery is for a proximal humeral fracture (not the typical indication) - You have had previous shoulder surgery - You have active shoulder infection, inflammatory arthropathy, rheumatoid arthritis, or gout - You are an active tobacco user or have smoked within the past 8 weeks - You have uncontrolled diabetes (HbA1C over 7.5%) - You have a life expectancy of less than 2 years or very high surgical risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRehabilitiation

This study will be a non-blinded randomized controlled outcomes study evaluating outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively from a primary reverse total shoulder arthroplasty with two different post-operative physical rehabilitation protocols. There will be 2 groups, one undergoing the immediate active shoulder physical therapy protocol consisting of four quadrant stretches and full active motion of the shoulder from post op day 1 in the hospital. The second group will follow the traditional TRIA physical therapy protocol consisting of PT (standard of care) followed by a gradual return to active range of motion of the shoulder beginning by week 6, calling for 18 physical therapy visits. The physical therapy will occur where the patient is most comfortable receiving it.


Locations(1)

TRIA Orthopaedic Center

Bloomington, Minnesota, United States

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NCT03804853


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