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Procedure
Shoulder Arthroplasty for Shoulder Osteoarthritis
N/A
Waitlist Available
Led By Christopher Joyce, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No important glenoid bone loss
Primary glenohumeral arthritis
Must not have
Axillary nerve damage
B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after date of surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the outcomes of two types of shoulder surgeries, reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA), in patients
Who is the study for?
This trial is for individuals with glenohumeral osteoarthritis, which affects the shoulder joint. Participants should not have rotator cuff tears or significant backward tilting of the socket part of their shoulder joint. The study is looking for people who can undergo surgery using a specific incision technique.
What is being tested?
The study compares two types of shoulder replacement surgeries: reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA). It aims to see if RTSA is at least as effective as TSA or even better, and whether it leads to fewer complications post-surgery.
What are the potential side effects?
Potential side effects from both surgical procedures may include pain, swelling, infection risk at the incision site, stiffness in the shoulder, possible damage to nerves or blood vessels around the operated area, and issues with implant components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My shoulder bone is intact without significant loss.
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I have arthritis in my shoulder joint.
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My rotator cuff is not damaged.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have damage to the nerve in my armpit area.
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My shoulder joint shows significant displacement and abnormal angle.
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I have a recent or poorly healed shoulder fracture.
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I have a complete tear in my shoulder tendon.
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I have a joint that has been stuck and out of place for a long time.
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I have rheumatoid arthritis.
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I have had previous surgeries.
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My deltoid muscle does not work.
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My shoulder socket is too damaged for surgery to attach a plate.
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I am able to make my own medical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months after date of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after date of surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
American Shoulder and Elbow Surgeons score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Reverse total shoulder replacementExperimental Treatment1 Intervention
Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.
Group II: Anatomic total shoulder replacementExperimental Treatment1 Intervention
Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reverse total shoulder replacement
2021
N/A
~130
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,145 Previous Clinical Trials
1,698,737 Total Patients Enrolled
Christopher Joyce, M.D.Principal InvestigatorUniversity of Utah Orthopaedics
2 Previous Clinical Trials
200 Total Patients Enrolled