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Shoulder ArthritisNCT03719859

Home Exercise vs PT for Reverse Total Shoulder Arthroplasty

A study testing Physical Therapy and Home Therapy in people with Shoulder Arthritis and Rotator Cuff Tear Arthropathy, run by Rush University Medical Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Physical Therapy and Home Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
7 sitesUnited States
Study dates
22 Jan 2019to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Anderson Orthopedic Clinic

    Arlington, Virginia, 22206

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • New England Baptist Hospital

    Dedham, Massachusetts, 02026

  • Western Orthopaedics

    Denver, Colorado, 80218

  • Centers for Advanced Orthopaedics

    Leonardtown, Maryland, 20650

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Multicenter Randomized Trial of Home vs. Physical Therapist-Directed Rehabilitation for Reverse Total Shoulder Arthroplasty

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.

Read the detailed description

Reverse total shoulder arthroplasty (RSA) is a relatively new solution for the patient with osteoarthritis of the glenohumeral joint with a deficient rotator cuff, or patients with glenohumeral osteoarthritis with excessive erosion of the posterior glenoid. Since the approval of RSA in 2003, the utility has increased such that this procedure represented 33% of all shoulder arthroplasties performed in the United States in 2011, and represents greater than 90% in some European countries The RSA prosthesis is effective at providing improved active motion and function due the semi-constrained design--substituting for the centering effect of the rotator cuff and allowing the deltoid to elevate or abduct the arm with fixed-fulcrum kinematics without a functional rotator cuff. Many factors influence the potential for successful outcome following RSA: proper patient selection, surgeon experience level, prosthesis characteristics, surgical technique and approach, and postoperative rehabilitation. Prior researchers have explored the effect of surgical technique, type of prosthesis, and surgery indications on outcome following RSA, however there is no data published on the impact of postoperative rehabilitation following this surgery.

A systematic review of the literature reveals that complications following RSA occur with four times greater incidence than complications following anatomic total shoulder arthroplasty (TSA). Complications following RSA which may be impacted by the exercises associated with physical therapy include instability and acromion stress fractures. A systematic review of the literature was conducted to determine if complication rates following RSA differ due to surgical approach, type of prosthesis (medialized or lateralized center of rotation), and the indication for the procedure. The authors of this review acknowledge that postoperative rehabilitation can impact the clinical and functional outcome of RSA and complication rate, however did not study this variable due to the heterogeneous approach to rehabilitation for the multi-center study.

Experts in the field of shoulder rehabilitation have published clinical guidelines for rehabilitation following reverse shoulder arthroplasty. One set of published guidelines is based on biomechanical and basic science healing timeframes associated with the tissue attrition following RSA. The authors describe precautions to protect the prosthesis from dislocation and acromial stress fractures, and propose a slow progressive approach to restoring motion and functional strength. The clinical guidelines published by these authors contrast with a very progressive criterion based rehabilitation plan that allows early use of the arm and very little immobilization. Neither of these two proposed rehabilitation plans are associated with clinical trials that track clinical or functional outcome measures or complication rate. A chapter devoted to rehabilitation following RSA in the book "Reverse Shoulder Arthroplasty" suggests that physician directed video-based rehabilitation may be just as effective as formal physical therapy. The author points out the need for randomized controlled trials to determine the need for physical therapy following a variety of shoulder surgeries. Clarifying the impact of formal clinic based PT intervention following RSA is important in determining the best plan of care for this population following surgery, while ensuring that there is not an increase in complications associated with the therapy.

Being tested
Physical Therapy, Home Therapy
Keywords
reverse total shoulder arthroplasty, physical therapy
Medical subject headings
Rotator Cuff Tear Arthropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical TherapyOther

    Also called PT

    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."

  • Home TherapyOther

    Also called HT

    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).

Study groups in NCT03719859
Study groupRoleWhat they receive
Physical Therapy (PT) GroupExperimentalSubjects will attend formal physical therapy after surgery.
Receives: Other: Physical Therapy
Home Therapy (HT) GroupActive comparatorSubjects will receive instruction from clinical staff regarding home therapy exercises after surgery.
Receives: Other: Home Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain: Numerical Rating Scale

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

    Measured: up to 2 years postoperatively

  2. 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

    Measured: up to two years postoperatively

  3. 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.

    Measured: up to two years postoperatively

  4. 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.

    Measured: up to two years postoperatively

Secondary outcomes (5)
  1. Complication rates

    acromial stress fractures and shoulder dislocations monitored by patient report through phone calls, patient visits, clinical exams, and standard of care imaging. All complications will be combined as a composite measure.

    Measured: up to 2 years postoperatively

  2. Cost of Care

    reimbursement for therapy services, total number of therapy visits, estimated travel time per visit, and associated costs. These measures will be combined in a cost-effectiveness analysis with a decision tree model.

    Measured: up to 2 years after surgery

  3. Quality adjusted life years: PROMIS-29

    assessed using Patient-Reported Outcomes Measurement Information System-29. PROMIS Profile instruments are a collection of short forms containing a fixed number of items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities).The PROMIS-29 assesses each of the 7 domains with 4 questions. Each of the 7 domains has a raw score range from 4 to 20 with 4 being the lowest score, indicating a poor outcome and 20 being the highest score, indicating a good outcome.(PROMIS-29) surveys

    Measured: up to 2 years postoperatively

  4. Postoperative Pain Medication Use Duration

    duration of narcotic medication usage as documented in the Illinois Prescription Monitoring Program (Illinois PMP) or equivalent monitoring program for non-Rush centers

    Measured: up to two years postoperatively

  5. Postoperative Pain Medication Prescription Refills

    number of narcotic medication prescription refills as documented in the Illinois Prescription Monitoring Program (Illinois PMP) or equivalent monitoring program for non-Rush centers

    Measured: up to two years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start22 Jan 2019
  3. Primary completion11 Aug 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719859
Sponsor's protocol ID
18082102
Status last verified
Dec 2025
First submitted
16 Oct 2018
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17548883
  • 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.

    PubMed 25440519
  • 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.

    PubMed 25441574
  • 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.

    PubMed 15726075
  • 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.

    PubMed 25709242
  • 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.

    PubMed 20865260
  • 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.

    PubMed 25937717
  • 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.

    PubMed 18560182
  • 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.

    PubMed 34886910

Questions about this trial

What is this clinical trial studying?

A study testing Physical Therapy and Home Therapy in people with Shoulder Arthritis and Rotator Cuff Tear Arthropathy, run by Rush University Medical Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain: Numerical Rating Scale (time frame: up to 2 years postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03719859, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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