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Procedure
Subscapularis Repair in Shoulder Replacement for Shoulder Arthritis
Phase < 1
Recruiting
Led By Jarret Woodmass, MD
Research Sponsored by Panam Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absence of neoplastic diseases at the treated site
Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-operative
Awards & highlights
Study Summary
This trial is testing whether repairing the subscapularis muscle after shoulder replacement surgery leads to better outcomes than not repairing it.
Who is the study for?
This trial is for individuals with shoulder arthritis or similar conditions who need their first RTSA implant and have a low-grade fatty infiltration in the subscapularis muscle. It's not for those who've had previous shoulder replacements, suffer from inflammatory arthritis, can't communicate in English, or won't be able to attend follow-up visits for 2 years.Check my eligibility
What is being tested?
The study is testing two approaches to shoulder replacement surgery (RTSA): one includes repairing the subscapularis muscle while the other does not. The outcomes of patients will be compared over a period of 24 months to see which method is more effective.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include pain at the surgery site, infection risk post-surgery, limited range of motion, stiffness in the shoulder joint, and possible complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have cancer at the site being treated.
Select...
I have shoulder joint issues and have decided with my surgeon to undergo a specific shoulder replacement.
Select...
My shoulder scan shows minimal fatty changes in the subscapularis muscle.
Select...
My shoulder tendon cannot be surgically fixed.
Select...
I am getting my first shoulder replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
ASES Score
Constant Score
EQ5D-3L
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RTSA with subscapularis repairExperimental Treatment1 Intervention
Group II: RTSA without subscapularis repairActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Panam ClinicLead Sponsor
16 Previous Clinical Trials
1,421 Total Patients Enrolled
University of ManitobaOTHER
595 Previous Clinical Trials
199,397 Total Patients Enrolled
Jarret Woodmass, MDPrincipal InvestigatorPan Am Clinic
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have cancer at the site being treated.I have had shoulder replacement surgery before.I have arthritis caused by a previous infection.I have shoulder joint issues and have decided with my surgeon to undergo a specific shoulder replacement.I have a broken upper arm bone near the shoulder.Your anatomy or medical condition requires a specific type of implant that is not bilateral.I can attend all study visits for up to 24 months after surgery.I have been diagnosed with avascular necrosis.My shoulder scan shows minimal fatty changes in the subscapularis muscle.I have inflammatory arthritis.My shoulder tendon cannot be surgically fixed.I cannot communicate in English.I am getting my first shoulder replacement.
Research Study Groups:
This trial has the following groups:- Group 1: RTSA with subscapularis repair
- Group 2: RTSA without subscapularis repair
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 new participants being accepted into this research endeavor?
"Correct. According to clinicaltrials.gov, this research initiative is presently recruiting participants with an initial posting date of November 1st, 2021 and most recent update on January 4th 2022. Eighty-four individuals are expected to enroll at a single medical hub."
Answered by AI
How many volunteers are taking part in the experiment?
"Affirmative. According to the data residing on clinicaltrials.gov, this medical trial commenced recruitment on November 1st 2021 and is still open for participants as of April 1st 2022. 84 individuals are required from a single site."
Answered by AI
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