Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03804853

Rehabilitation Following Reverse Total Shoulder Arthroplasty

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
74 (estimated)
Sponsor
HealthPartners Institute · Academic / Other
Sex
All
Age
55 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRehabilitiationThis 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.

Timeline

Start date
2018-12-12
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2019-01-15
Last updated
2025-06-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03804853. Inclusion in this directory is not an endorsement.