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Home Exercise vs PT for Reverse Total Shoulder Arthroplasty

NCT03719859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-22

No results posted yet for this study

Summary

The primary objective of this study is to compare outcomes between formal clinic based physical therapy (PT) rehabilitation and surgeon directed home therapy (HT) after reverse total shoulder arthroplasty (RSA) as measured by pain, range of motion, Single Assessment Numerical Evaluation (SANE), and American Shoulder and Elbow Surgery (ASES) scores at 6 weeks, 3, 6, 12, and 24 months postoperatively. The secondary objective of this study is to determine if PT rehabilitation following RSA is associated with a higher level of postoperative complications, specifically acromial stress fractures or dislocation. This information will be useful to discern if PT is effective in providing pain relief more quickly, as well as improved motion and self-reported functional outcomes following RSA, which can assist surgeons and rehabilitation specialists in designing optimal care plans for this patient population. The project will also help to clarify if PT services place patients who have RSA at higher risk for acromial stress fractures or dislocation.

Conditions

  • Shoulder Arthritis
  • Rotator Cuff Tear Arthropathy

Interventions

OTHER

Physical Therapy

Subjects who will participate in the physical therapy intervention group will attend therapy 4-6 days after discharge from the hospital, and continue in therapy approximately once a week for three months. The physical therapy progression will follow the standard of care developed at Duke Sports Medicine Physical Therapy for rehabilitation following RSA. Some of the patients in the PT intervention cohort may have physical therapy at an institution outside of Midwest Orthopaedics at Rush. All patients, whether in the Rush system or outside, will be given a prescription with the identical instructions for "physical therapy, status post (R/L) reverse total shoulder arthroplasty, 1-2 x per week x 12 weeks."

OTHER

Home Therapy

The surgeon/Nurse Practitioner/Physician Assistant will advance rehabilitation exercises and activity guidelines at customary scheduled postoperative appointments for this surgical procedure: 2 weeks (+/- 5 days), 6 weeks (+/- 1 week), 3 months and 6 months (+/- 1 month), and 1 and 2 years (+/- 2 months).

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Grant E Garrigues, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2025-08-11
Completion
2025-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719859 on ClinicalTrials.gov