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N/A

Total vs Reverse Shoulder Arthroplasty for Shoulder Osteoarthritis (SERVASA Trial)

N/A
Recruiting
Led By Peter Lapner, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- 65 years of age and older
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
Must not have
Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
Charcot's arthropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-months and 5-years post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two shoulder surgery options for patients with glenohumeral osteoarthritis.

Who is the study for?
This trial is for people over 65 with severe shoulder osteoarthritis who haven't improved after 6 months of non-surgical treatments like physiotherapy and painkillers. It's not for those with a life expectancy under a year, high surgery risk, psychiatric conditions affecting consent, pregnancy, or previous shoulder surgeries on the affected side.
What is being tested?
The study is comparing two types of shoulder replacement surgeries: Total Shoulder Arthroplasty (TSA) and Reverse Shoulder Arthroplasty (RSA). Participants will be randomly assigned to one of these surgical options to see which is better for treating advanced glenohumeral osteoarthritis in seniors.
What are the potential side effects?
Possible side effects from both TSA and RSA may include pain at the surgery site, swelling, stiffness in the shoulder joint, infection risks post-operation, complications related to anesthesia during surgery, and potential need for future corrective surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
Select...
My shoulder joint shows advanced cartilage loss.
Select...
My shoulder arthritis hasn't improved with standard treatments, and I need surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a major illness that would give me less than a year to live.
Select...
I have Charcot's joint disease.
Select...
My joint cannot be surgically fixed to almost straight.
Select...
I currently have an infection in my joints or throughout my body.
Select...
I have had shoulder surgery on the same side as my current condition.
Select...
I have shoulder joint damage due to rotator cuff issues.
Select...
I have significant muscle weakness or paralysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-months and 5-years post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-months and 5-years post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Secondary study objectives
Adverse Events (AE) and Serious Adverse Events (SAE)
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
Constant Score
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Total Shoulder Arthroplasty (anatomic)Active Control1 Intervention
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components.
Group II: Reverse Shoulder ArthroplastyActive Control1 Intervention
RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,792 Total Patients Enrolled
Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital
12 Previous Clinical Trials
1,204 Total Patients Enrolled

Media Library

Reverse Shoulder Arthroplasty (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04228419 — N/A
Shoulder Arthritis Research Study Groups: Total Shoulder Arthroplasty (anatomic), Reverse Shoulder Arthroplasty
Shoulder Arthritis Clinical Trial 2023: Reverse Shoulder Arthroplasty Highlights & Side Effects. Trial Name: NCT04228419 — N/A
Reverse Shoulder Arthroplasty (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228419 — N/A
~2 spots leftby Jan 2025
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