Rehabilitation Following Reverse Total Shoulder Arthroplasty

Part of paid clinical trials in Bloomington, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT03804853
Status
Recruiting
Apply to this trial

Conditions

  • Shoulder Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rehabilitiation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 12, 2018
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Active Shoulder Rehabilitation
  • Active Comparator: Traditional Should Rehabilitation

Primary Outcome Measure

American Society for Elbow and Shoulder Score [ Time Frame: Pre-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
TRIA Orthopaedic CenterBloomingtonMinnesota55431
Megan Reams
[email protected]
952-806-5329
Michael Walsh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bloomington, MN

By research site
TRIA Orthopaedic Center· Bloomington, MN

Related Studies