No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
55 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
HealthPartners Institute · Other
Who this trial is looking for
This trial is looking for patients over 55 who need a specific shoulder surgery. Participants will compare two types of rehabilitation after their surgery and help researchers understand which method is better.
Are You a Good Fit for This Trial?
Rules you outRheumatoid arthritisGoutPeripheral vascular diseaseCervical radiculopathy
You may be able to join if
I am over 55 years old.
I am a candidate for reverse total shoulder arthroplasty.
I can complete questionnaires on my own.
I can return for all follow-up procedures.
I can give informed consent.
I speak and understand English.
You may not be able to join if
I am planning surgery for a shoulder fracture.
I have had previous shoulder surgeries.
I have an active infection in my shoulder.
I have other upper limb problems needing treatment.
I have inflammatory arthritis.
I have uncontrolled diabetes.
I use tobacco or have used it in the last 8 weeks.
I have a major medical illness affecting my life expectancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 bu…
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.
Trial Locations
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Eligibility Criteria
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…
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).
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