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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
Must not have
Subject has an active infection at or near the site of implantation
Subject is currently on or planning to be on chemotherapy or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks,6 months, and 1, 2, 5 and 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am 21 years old or older.
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I am scheduled for a specific shoulder replacement due to severe joint disease and a major rotator cuff issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection where my medical device was or will be placed.
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I am currently undergoing or planning to start chemotherapy or radiation.
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I have undergone chemotherapy or radiation in the past 6 months.
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I have been taking more than 5mg/day of corticosteroids, not including inhalers, in the last 3 months.
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I am not pregnant nor planning to become pregnant during the study.
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I am scheduled for a specific shoulder surgery and may need additional muscle transfers.
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I have an active cancer that has spread, or I have Paget's or Charcot's disease.
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I have a muscle or nerve condition affecting my shoulder.
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My shoulder muscle doesn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks,6 months, and 1, 2, 5 and 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks,6 months, and 1, 2, 5 and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

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

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~80 spots leftby Dec 2028
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