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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
- Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
- 65 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-months and 5-years post-operative
Awards & highlights

SERVASA Trial 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.Check my eligibility
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.See study design
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.

SERVASA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am undergoing physiotherapy with exercises and treatments like ultrasound.
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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.
Select...
I have changed my daily activities due to my condition.
Select...
I am receiving treatment that does not involve surgery.
Select...
I still have pain and disability after 6 months of standard non-surgical treatment.
Select...
My shoulder socket has minimal wear and is mostly straight.
Select...
I am currently taking painkillers or anti-inflammatory drugs.

SERVASA Trial 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

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

SERVASA 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
561 Previous Clinical Trials
2,785,583 Total Patients Enrolled
Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital
12 Previous Clinical Trials
2,985 Total Patients Enrolled

Media Library

Reverse Shoulder Arthroplasty (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04228419 — N/A
Shoulder Osteoarthritis Research Study Groups: Total Shoulder Arthroplasty (anatomic), Reverse Shoulder Arthroplasty
Shoulder Osteoarthritis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study being conducted in more than one country, and if so, where?

"At the moment, there are 6 clinical trial sites where patients can be enrolled. The locations are in Kingston, Winnipeg and London as well as 6 other cities. If you choose to participate in this study, it would be helpful to select the location nearest you so that you don't have to travel far."

Answered by AI

How many people are the maximum that can be a part of this research?

"Yes, the clinicaltrials.gov website currently has this study listed as open and recruiting patients. The listing shows that the trial was originally posted on March 9th 2020, with the most recent update being on July 1st 2022. This particular research project is seeking 108 volunteers at 6 different locations."

Answered by AI

Are participants being sought for this experiment currently?

"Yes, according to the information on clinicaltrials.gov, this trial is still recruiting patients. It was first posted on 3/9/2020 and was last updated on 7/1/2022. The study is looking for 108 patients at 6 different sites."

Answered by AI
~17 spots leftby Jan 2025