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Subscapularis Repair in Reverse Shoulder Arthroplasty for Rotator Cuff Syndrome
N/A
Waitlist Available
Research Sponsored by Encore Medical, L.P.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥21 years of age
Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks,6 months, and 1, 2, 5 and 10 years
Awards & highlights
Study Summary
This trial will compare repairing the subscapularis muscle to not repairing it during reverse shoulder surgery. It is hypothesized that repairing the subscapularis will result in improved postoperative strength.
Who is the study for?
This trial is for individuals over 21 needing reverse shoulder arthroplasty due to severe joint issues with a deficient rotator cuff. They must be able to follow the study plan, have a repairable subscapularis muscle as confirmed by MRI, and not be pregnant or planning pregnancy during the study. Exclusions include metal allergies, active infections near implantation site, high corticosteroid use, nonfunctional deltoid muscle, cognitive impairments affecting participation, recent chemotherapy or radiation treatment, substance abuse issues.Check my eligibility
What is being tested?
The trial tests whether repairing the subscapularis muscle improves strength after receiving an AltiVate Reverse® Shoulder System implant in patients undergoing reverse total shoulder arthroplasty. It's a prospective (forward-looking), multi-center study where participants are randomly assigned to either get their subscapularis repaired or not and then compared.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at surgery site, infection risk from implants or surgery itself; possible allergic reactions if unknown metal sensitivity exists; complications related to anesthesia; and general surgical risks like bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I am scheduled for a specific shoulder replacement due to severe joint disease and a major rotator cuff issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks,6 months, and 1, 2, 5 and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks,6 months, and 1, 2, 5 and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in isometric and isokinetic internal rotational strength of abductors
Change in isometric and isokinetic internal rotational strength of external rotators
Change in isometric and isokinetic internal rotational strength of flexors
+1 moreSecondary outcome measures
To evaluate change in general health with the AltiVate Reverse® Shoulder
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
The subscapularis is not repaired. Receives device
Group II: Group AExperimental Treatment2 Interventions
The subscapularis is repaired. Receives device
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Who is running the clinical trial?
Encore Medical, L.P.Lead Sponsor
21 Previous Clinical Trials
3,402 Total Patients Enrolled
Jessica Knowlton, MS, CRAStudy DirectorDJO Global
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of cognitive or mental health issues that could make it difficult for you to participate in the study.I am currently undergoing or planning to start chemotherapy or radiation.You are currently using drugs or alcohol excessively, or receiving treatment for substance abuse.I am 21 years old or older.I have an infection where my medical device was or will be placed.I have undergone chemotherapy or radiation in the past 6 months.I am scheduled for a specific shoulder replacement due to severe joint disease and a major rotator cuff issue.I have been taking more than 5mg/day of corticosteroids, not including inhalers, in the last 3 months.I am not pregnant nor planning to become pregnant during the study.I am scheduled for a specific shoulder surgery and may need additional muscle transfers.I have an active cancer that has spread, or I have Paget's or Charcot's disease.I have a muscle or nerve condition affecting my shoulder.My MRI shows my shoulder muscle can be repaired.You are allergic or sensitive to metals.My shoulder muscle doesn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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.
How many medical institutions are participating in this research?
"Patients for this trial are being recruited from Texas Orthopedic Group in Houston, NYU Langone Center for Musculoskeletal Care in New york City, Rothman Institute in Philadelphia as well as 4 additional sites."
Answered by AI
Is there an ongoing enrollment process for this research study?
"According to the information found on clinicaltrials.gov, recruiting for this trial is not active at present time. It was initially listed September 28th 2018 and last updated March 21st 2022; however, there are 132 other trials actively seeking enrolment from patients currently."
Answered by AI
What objectives is the clinical trial seeking to accomplish?
"This medical trial intends to assess the isometric and isokinetic internal rotational strength of flexors over a 6 month, 1 year, 2 year, 5 year, and 10-year period. Other objectives include measuring device survivorship of the AltiVate Reverse® Shoulder through adverse event analysis, evaluating changes in general health as indicated by VR-12 scores, and examining radiographic parameters related to use of the AltiVate Reverse® Shoulder."
Answered by AI
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