Shoulder Arthropathy Associated With Other Conditions
Conditions
Keywords
Reverse Total Shoulder Arthroplasty, post operative physical therapy
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.
Interventions
OTHERhome therapy
Patients will be given a set of instructions for completing home therapy for range of motion and strengthening
OTHERformal therapy
Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
post operative assessor obtaining range of motion and performing physical exam will be blinded to participant's group.
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion Outcomes | Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively | Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome Scores - Quality of Life | Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively | Compare change in The Western Ontario Osteoarthritis Score (WOOS) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty. The WOOS includes 19 items (0-100 visual analog scale) which assess 1. pain and physical symptoms 2. sports, recreation, and work 3. lifestyle function, and 4. emotional function. A higher score represents a worse outcome. |
| Clinical Outcome Scores - Functional | Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively | Compare change in American Shoulder and Elbow Surgeons Score (ASES) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty. The ASES includes 1 pain item (0-100 visual analog scale) and 10 items which assess functional status (0=Unable to do, 1=Very difficult to do, 2=Somewhat difficult, 3=Not difficult). A higher score represents a better outcome. |
| Clinical Outcome Scores - Pain | Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively | Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty. |
Countries
United States
Outcome results
None listed