Rehabilitation Following Reverse Total Shoulder Arthroplasty
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 1/19/2019 |
| Start Date: | December 12, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Megan Reams |
| Email: | megan.reams@tria.com |
| Phone: | 952-806-5329 |
Immediate Accelerated Shoulder Rehabilitation Versus a Standard Protocol Following Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial
Reverse total shoulder arthroplasty (RTSA) has been successful in patients with rotator cuff
arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed
hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA
report pain relief and functional range of motion. It has been more than 20 years since the
advent of the RTSA construct but an immediate post-operative rehabilitation with active
shoulder range of motion has not been prospectively studied in comparison to the traditional
post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to
prospectively follow our patients following RTSA undergoing an immediate active shoulder
rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion.
Investigators plan to document clinical outcomes, complications and cost effectiveness out to
1 year.
The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the
health of the population, improve the experience of each individual, and make healthcare
affordable by decreasing the total cost of care.
arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed
hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA
report pain relief and functional range of motion. It has been more than 20 years since the
advent of the RTSA construct but an immediate post-operative rehabilitation with active
shoulder range of motion has not been prospectively studied in comparison to the traditional
post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to
prospectively follow our patients following RTSA undergoing an immediate active shoulder
rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion.
Investigators plan to document clinical outcomes, complications and cost effectiveness out to
1 year.
The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the
health of the population, improve the experience of each individual, and make healthcare
affordable by decreasing the total cost of care.
Inclusion Criteria:
- > 55 years of age.
- Candidate for a primary reverse total shoulder arthroplasty.
- Capable of completing self-administered questionnaires.
- Be willing and able to return for all study-related follow-up procedures.
- Able and willing to give informed consent.
- Proficient in the English language.
Exclusion Criteria:
In-Clinic:
- Patients planning on undergoing a Primary Reverse Shoulder Total Arthroplasty due to
proximal humeral fracture.
- Previous shoulder surgery including previous total shoulder arthroplasty or reverse
total shoulder arthroplasty or hemiarthroplasty, or instability repairs
- Active bacterial infection of the shoulder.
- Any concomitant shoulder procedure.
- Additional ipsilateral or contralateral upper limb pathology that requires active
treatment (i.e. surgery or brace).
- Inflammatory arthropathy.
- Diagnosed with Rheumatoid arthritis
- Diagnosed with gout.
- Subject is on chronic anticoagulation due to a bleeding disorder or has taken
anticoagulants within 10 days prior to surgery.
- Peripheral vascular disease or other vascular disorders that would impair healing.
- Peripheral neuropathy or other neurological disorders that may impair the patient to
ambulate.
- Patient is on workers compensation.
- Any condition requiring chemotherapy.
- Active tobacco user or former tobacco user who is not free of using tobacco for 8
weeks.
- Uncontrolled Diabetes Mellitus with an HbA1C > 7.5%.
- Current drug or alcohol abuse.
- Major medical illness (life expectancy less then 2 years or unacceptably high
operative risk)
- Suspicion of cervical radiculopathy or myelopathy.
- Deltoid insufficiency on physical examination.
Intra-operative:
• Iatrogenic glenoid fracture
Post-operative:
- Neurological injury of the upper extremity.
- Complications from Primary Reverse Shoulder Total Arthroplasty (i.e. post-operative
infection, bleeding, hardware failure).
We found this trial at
1
site
Bloomington, Minnesota 55431
Principal Investigator: Michael Walsh, MD
Phone: 952-806-5329
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