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Procedure
Shoulder Replacement Surgeries for Shoulder Osteoarthritis (SERVASA15 Trial)
N/A
Recruiting
Led By Peter Lapner, MD FRCSC
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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-years post-operative
Awards & highlights
SERVASA15 Trial Summary
This trial compares two shoulder surgeries for elderly with advanced arthritis and 15+ degrees of retroversion.
Who is the study for?
This trial is for people aged 65 and older with advanced shoulder osteoarthritis and a specific bone condition (over 15 degrees of glenoid retroversion). They must have tried standard treatments like painkillers, physiotherapy, and lifestyle changes for at least six months without success. Those who've had previous shoulder surgery or suffer from certain other conditions can't join.Check my eligibility
What is being tested?
The study is comparing two surgical procedures for severe shoulder arthritis: Total Shoulder Arthroplasty with an augmented component versus Reverse Shoulder Arthroplasty. It's designed to find out which surgery works better for patients with the specified bone condition in their shoulders.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, bleeding, pain at the site of operation, stiffness or difficulty moving the shoulder, nerve damage around the operated area, and possible need for additional surgeries if complications occur.
SERVASA15 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-years post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years post-operative
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 moreSERVASA15 Trial Design
2Treatment groups
Active Control
Group I: Total Shoulder Arthroplasty (anatomic) + augmented glenoid componentActive Control1 Intervention
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial 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
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,609 Total Patients Enrolled
Peter Lapner, MD FRCSCPrincipal InvestigatorThe Ottawa Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with shoulder arthritis of unknown cause.I have shoulder joint damage due to rotator cuff issues.I currently have an infection in my joints or throughout my body.My joint cannot be surgically fixed to almost straight.I have significant muscle weakness or paralysis.My shoulder joint shows advanced cartilage loss.I am 65 years old or older.My shoulder arthritis hasn't improved with regular treatments, and I need surgery.I have rheumatoid arthritis in my shoulder.I have Charcot's joint disease.I do not have a major illness that would give me less than a year to live.My shoulder joint has a specific type of bone loss and tilt.I have had shoulder surgery on the same side as my current condition.
Research Study Groups:
This trial has the following groups:- Group 1: Total Shoulder Arthroplasty (anatomic) + augmented glenoid component
- Group 2: Reverse Shoulder Arthroplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are current participants being enrolled in this experiment?
"The data on clinicaltrials.gov indicates that recruitment for this trial is ongoing; it was initially posted on August 9th, 2022 and recently updated March 1st, 2023."
Answered by AI
To what degree is this clinical trial being utilized by participants?
"Affirmative. According to information on clinicaltrials.gov, the trial that commenced posting on August 9th 2022 has remained active and is actively searching for 108 recruits from one site. This was last updated March 1st 2023."
Answered by AI
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