Home Exercise vs PT for Reverse Total Shoulder Arthroplasty



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:2/17/2019
Start Date:January 22, 2019
End Date:October 31, 2020
Contact:Amanda J Naylor, MA
Email:shoulder.research@rushortho.com
Phone:3124322337

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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.

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.

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)
We found this trial at
7
sites
Washington, District of Columbia 20007
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Arlington, Virginia 22206
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Arlington, VA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Grant E Garrigues, MD
Phone: 312-432-2337
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cleveland, OH
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40 Allied Drive
Dedham, Massachusetts 02026
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Dedham, MA
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Denver, Colorado 80218
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Denver, CO
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Leonardtown, Maryland 20650
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Leonardtown, MD
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