Clinical trial NCT03719859: Home Exercise vs PT for Reverse Total Shoulder Arthroplasty
Official title: Multicenter Randomized Trial of Home vs. Physical Therapist-Directed Rehabilitation for Reverse Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Shoulder Arthritis
Rotator Cuff Tear Arthropathy
Keywords: reverse total shoulder arthroplasty
physical therapy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2018-10-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Postoperative Pain: Numerical Rating Scale
timeFrame: up to 2 years postoperatively
measure: Range of motion
timeFrame: up to two years postoperatively
measure: Patient-reported functional outcome- American Shoulder and Elbow Surgeons Score
timeFrame: up to two years postoperatively
measure: Patient-reported functional outcome- Single Assessment Numeric Evaluation score
timeFrame: up to two years postoperatively
Secondary outcomes:
measure: Complication rates
timeFrame: up to 2 years postoperatively
measure: Cost of Care
timeFrame: up to 2 years after surgery
measure: Quality adjusted life years: PROMIS-29
timeFrame: up to 2 years postoperatively
measure: Postoperative Pain Medication Use Duration
timeFrame: up to two years postoperatively
measure: Postoperative Pain Medication Prescription Refills
timeFrame: up to two years postoperatively
Other outcomes:
Locations:
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Leonardtown
country: United States
facility: Centers for Advanced Orthopaedics
state: Maryland
city: Dedham
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Arlington
country: United States
facility: Anderson Orthopedic Clinic
state: Virginia
Study officials:
affiliation: Rush University Medical Center
name: Grant E Garrigues, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.