Recruiting

Rehabilitation

Sponsor:

HealthPartners Institute

Code:

NCT03804853

Conditions

Shoulder Osteoarthritis

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Rehabilitiation

Study Details

Brief 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

Shoulder Osteoarthritis

Study ID

NCT03804853

Start date

Dec 12, 2018

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Active Shoulder Rehabilitation

active comparator: Traditional Should Rehabilitation

Interventions

Rehabilitiation

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.

Primary outcome measure

  • American Society for Elbow and Shoulder Score [ Time Frame: Pre-operatively ]
  • American Society for Elbow and Shoulder Score [ Time Frame: 2 weeks ]
  • American Society for Elbow and Shoulder Score [ Time Frame: 3 months ]
  • American Society for Elbow and Shoulder Score [ Time Frame: 6 months ]
  • American Society for Elbow and Shoulder Score [ Time Frame: 1 year ]
  • Simple Shoulder Test [ Time Frame: Pre-operatively ]
  • Simple Shoulder Test [ Time Frame: 2 weeks ]
  • Simple Shoulder Test [ Time Frame: 3 months ]
  • Simple Shoulder Test [ Time Frame: 6 months ]
  • Simple Shoulder Test [ Time Frame: 1 year ]
  • PROMIS Global 10 [ Time Frame: Pre-operatively ]
  • PROMIS Global 10 [ Time Frame: 2 weeks ]
  • PROMIS Global 10 [ Time Frame: 3 months ]
  • PROMIS Global 10 [ Time Frame: 6 months ]
  • PROMIS Global 10 [ Time Frame: 1 year ]
  • Range of Motion [ Time Frame: Pre-operatively, 3 months, 6 months, 1 year post-operatively ]
  • Range of Motion [ Time Frame: 3 months ]
  • Range of Motion [ Time Frame: 6 months ]
  • Range of Motion [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Megan Reams

952-806-5329megan.reams@tria.com

Locations

TRIA Orthopaedic Center

Recruiting

Bloomington, Minnesota, United States, 55431

Contacts

Megan Reams

952-806-5329institute@tria.com

Principal Investigator:

Michael Walsh, MD

More Information

Sponsor

HealthPartners Institute

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Rehabilitiation
  • Reverse total shoulder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2026-06-26.