Clinical trial NCT03430167: Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
Official title: Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthropathy Associated With Other Conditions
Keywords: Reverse Total Shoulder Arthroplasty
post operative physical therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 90
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.

Detailed description: All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function.

Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively.

Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty.

Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.

Eligibility criteria: Inclusion Criteria:

1. Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
2. A pre-operative plan for RTSA
3. Age \>60

Exclusion Criteria:

1. Active infection
2. Incompetent deltoid muscle
3. Unwillingness or inability to participate in a home exercise program
4. Medically unfit for operative intervention
5. Revision RTSA
6. RTSA for glenohumeral osteoarthritis or proximal humerus fracture
7. Unwillingness to participate in the study
8. Inability to read or comprehend written instructions

Primary outcomes:
measure: Range of Motion Outcomes
timeFrame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Secondary outcomes:
measure: Clinical Outcome Scores - Quality of Life
timeFrame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
measure: Clinical Outcome Scores - Functional
timeFrame: Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively
measure: Clinical Outcome Scores - Pain
timeFrame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah - Orthopedics
state: Utah
Study officials:
affiliation: Washington University School of Medicine
name: Aaron Chamberlain, MD
role: PRINCIPAL_INVESTIGATOR
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