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Procedure
Shoulder Surgery Techniques for Shoulder Osteoarthritis
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
Patients with advanced osteoarthritis of the glenohumeral joint
Imaging confirming advanced humeral head cartilage loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-years post-operative
Awards & highlights
Study Summary
This trial is being done to compare two different surgeries for shoulder osteoarthritis, in order to find out which one produces better outcomes.
Who is the study for?
This trial is for adults over 18 with shoulder osteoarthritis who haven't improved after 6 months of non-surgical treatments like painkillers, lifestyle changes, and physiotherapy. Candidates should have specific degrees of bone erosion in their shoulder socket but can't join if they've had previous shoulder surgery on the affected side, certain other joint diseases or infections, severe medical conditions, or are pregnant.Check my eligibility
What is being tested?
The study compares two surgical techniques for advanced shoulder osteoarthritis: one involves implanting a special component and removing some bone from the front of the socket (eccentric reaming), while the other combines this component with a bone graft. The goal is to see which method gives better results.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from such surgeries may include pain at the surgery site, infection risk, stiffness or difficulty moving the shoulder, nerve damage around operated area and potential need for additional surgeries if complications occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe shoulder arthritis.
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My scans show severe cartilage loss in my shoulder.
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I am 18 years old or older.
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I have had pain and disability for 6 months despite treatment.
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My arthritis can be treated with shoulder replacement surgery.
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
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Participants with 10-15 degrees of glenoid retroversionActive Control2 Interventions
Group II: Participants with >15 degrees of glenoid retroversionActive Control2 Interventions
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,478 Total Patients Enrolled
Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital
12 Previous Clinical Trials
2,877 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe shoulder arthritis.My scans show severe cartilage loss in my shoulder.I have had shoulder surgery on the same side as my current condition.I am 18 years old or older.I have significant muscle weakness or paralysis.I have shoulder joint damage due to rotator cuff issues.I have had pain and disability for 6 months despite treatment.I have Charcot's joint disease.I have rheumatoid arthritis in my shoulder.My surgeon has recommended a shoulder replacement for me.I am not willing to participate in the study for its full duration.My joint cannot be surgically fixed to almost straight.I have a serious illness and am expected to live less than a year.My arthritis can be treated with shoulder replacement surgery.I currently have an infection in my joints or throughout my body.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with 10-15 degrees of glenoid retroversion
- Group 2: Participants with >15 degrees of glenoid retroversion
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 there any available enrolment opportunities for this research project?
"Clinicaltrials.gov's records show that this clinical trial, which was created on April 23rd 2017 and last modified on April 19th 2022, is currently recruiting patients."
Answered by AI
What is the total populace involved in this research project?
"Affirmative. Clinicaltrials.gov has indicated that the clinical trial, which was initially created on April 23rd 2017 and last updated in April 19th 2022, is actively enlisting participants. As such, 216 individuals are needed to be recruited from two separate facilities."
Answered by AI
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