Subscapularis Repair in Reverse Shoulder Arthroplasty for Rotator Cuff Syndrome

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Encore Medical, L.P.

No Placebo Group

Trial Summary

What is the purpose of this trial?The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.

Eligibility Criteria

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.

Inclusion Criteria

Subject is likely to be available for evaluation for the duration of the study

I am 21 years old or older.

I am scheduled for a specific shoulder replacement due to severe joint disease and a major rotator cuff issue.

+3 more

Exclusion 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.

+10 more

Participant Groups

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.

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