Home Exercise vs PT for Reverse Total Shoulder Arthroplasty

NCT03719859 | Completed

• 1 other identifier: 18082102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

reverse total shoulder arthroplasty; physical therapy

Outcome Measures

Primary Outcomes (4)

• Postoperative Pain: Numerical Rating Scale

  Pain measured using 0-10 Numeric Pain Rating Scale (NRS) with 0 being a better score

  up to 2 years postoperatively

• Range of motion

  Clinician measure of function using active and passive forward elevation, external rotation with the arm at the side in adduction and at 90 degrees of abduction in the scapular plane, and active internal rotation measured by highest vertebral level reached with thumb

  up to two years postoperatively

• Patient-reported functional outcome- American Shoulder and Elbow Surgeons Score

  American Shoulder and Elbow Surgeons (ASES). Survey is scored 0 to 100 with 0 being the lowest possible score indicating a poor outcome and 100 being the highest possible score and indicating a good outcome.

  up to two years postoperatively

• Patient-reported functional outcome- Single Assessment Numeric Evaluation score

  Single Assessment Numeric Evaluation (SANE) score. Survey is scored 0 to 100 with 0 being the lowest possible score indicating a poor outcome and 100 being the highest possible score and indicating a good outcome.

  up to two years postoperatively

Secondary Outcomes (5)

• Complication rates

  up to 2 years postoperatively

• Cost of Care

  up to 2 years after surgery

• Quality adjusted life years: PROMIS-29

  up to 2 years postoperatively

• Postoperative Pain Medication Use Duration

  up to two years postoperatively

• Postoperative Pain Medication Prescription Refills

  up to two years postoperatively

Study Arms (2)

Physical Therapy (PT) Group

EXPERIMENTAL

Subjects will attend formal physical therapy after surgery.

Other: Physical Therapy

Home Therapy (HT) Group

ACTIVE COMPARATOR

Subjects will receive instruction from clinical staff regarding home therapy exercises after surgery.

Other: Home Therapy

Interventions

Physical Therapy OTHER

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."

Also known as: PT

Physical Therapy (PT) Group

Home Therapy OTHER

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).

Also known as: HT

Home Therapy (HT) Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have RSA for cuff tear arthropathy, massive irreparable rotator cuff tear with pseudoparalysis, or primary osteoarthritis.

You may not qualify if:

• Subjects who have a non-reverse total shoulder arthroplasty, RSA for fracture, tendon transfers as part of RSA, and revision RSA
• Subjects who had RSA and require discharge to skilled nursing facility, in-patient rehabilitation placement, or use of home health therapy prior to progressing in recovery
• Subjects who cannot speak, read, or write the English language
• Subjects who have cognitive deficits limiting ability to follow directions
• Subjects who have inability to attend physical therapy (i.e. transportation or financial limitations)

Sponsors & Collaborators

• Rush University Medical Center: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (7)

Western Orthopaedics

Denver, Colorado, 80218, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Centers for Advanced Orthopaedics

Leonardtown, Maryland, 20650, United States

Location

New England Baptist Hospital

Dedham, Massachusetts, 02026, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Anderson Orthopedic Clinic

Arlington, Virginia, 22206, United States

Location

Related Publications (9)

• Ecklund KJ, Lee TQ, Tibone J, Gupta R. Rotator cuff tear arthropathy. J Am Acad Orthop Surg. 2007 Jun;15(6):340-9. doi: 10.5435/00124635-200706000-00003.

  PMID: 17548883 BACKGROUND

• Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015 Jan;24(1):91-7. doi: 10.1016/j.jse.2014.08.026. Epub 2014 Oct 29.

  PMID: 25440519 BACKGROUND

• Berliner JL, Regalado-Magdos A, Ma CB, Feeley BT. Biomechanics of reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Jan;24(1):150-60. doi: 10.1016/j.jse.2014.08.003. Epub 2014 Oct 29.

  PMID: 25441574 BACKGROUND

• Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):147S-161S. doi: 10.1016/j.jse.2004.10.006.

  PMID: 15726075 BACKGROUND

• Samitier G, Alentorn-Geli E, Torrens C, Wright TW. Reverse shoulder arthroplasty. Part 1: Systematic review of clinical and functional outcomes. Int J Shoulder Surg. 2015 Jan-Mar;9(1):24-31. doi: 10.4103/0973-6042.150226.

  PMID: 25709242 BACKGROUND

• Farshad M, Gerber C. Reverse total shoulder arthroplasty-from the most to the least common complication. Int Orthop. 2010 Dec;34(8):1075-82. doi: 10.1007/s00264-010-1125-2. Epub 2010 Sep 25.

  PMID: 20865260 BACKGROUND

• Alentorn-Geli E, Samitier G, Torrens C, Wright TW. Reverse shoulder arthroplasty. Part 2: Systematic review of reoperations, revisions, problems, and complications. Int J Shoulder Surg. 2015 Apr-Jun;9(2):60-7. doi: 10.4103/0973-6042.154771.

  PMID: 25937717 BACKGROUND

• Boudreau S, Boudreau ED, Higgins LD, Wilcox RB 3rd. Rehabilitation following reverse total shoulder arthroplasty. J Orthop Sports Phys Ther. 2007 Dec;37(12):734-43. doi: 10.2519/jospt.2007.2562. Epub 2007 Aug 28.

  PMID: 18560182 BACKGROUND

• Kennedy JS, Reinke EK, Friedman LGM, Cook C, Forsythe B, Gillespie R, Hatzidakis A, Jawa A, Johnston P, Nagda S, Nicholson G, Sears B, Wiesel B, Garrigues GE; SHORT Trial Investigators; Hagen C, Hong I, Roach M, Jones N, Mahendraraj K, Michaelson E, Bader J, Mauter L, Mengers S, Renko N, Strony J, Hart P, Steele E, Naylor A, Gaudette J, Sprengel K. Protocol for a multicenter, randomised controlled trial of surgeon-directed home therapy vs. outpatient rehabilitation by physical therapists for reverse total shoulder arthroplasty: the SHORT trial. Arch Physiother. 2021 Dec 10;11(1):28. doi: 10.1186/s40945-021-00121-2.

  PMID: 34886910 DERIVED

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Physical Therapy Modalities; Home Infusion Therapy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Drug Therapy; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Grant E Garrigues, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to one of two groups (surgeon directed home therapy or formal physical therapy). If subjects in either group are dissatisfied with the outcome of their rehabilitation process, they will be afforded the opportunity to cross-over to the other arm of the study.

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 25, 2018
• Study Start: January 22, 2019
• Primary Completion: August 11, 2025
• Study Completion: December 12, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)