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Not Applicable

Subscapularis Repair for Rotator Cuff Tears (Subscap Trial)

N/A

Recruiting

Research Sponsored by Arthrex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system

Patient is between 18-100 years old

Must not have

Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

History of shoulder septic arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of repairing or not repairing the subscapularis tendon during a reverse shoulder arthroplasty.

Who is the study for?

This trial is for adults aged 18-100 who need reverse shoulder arthroplasty using the Arthrex system and can follow post-op care, including physical therapy. They must be able to participate in another related registry study. Excluded are those with prior surgeries affecting the subscapularis tendon, previous shoulder replacements, substance abuse issues, or conditions like rheumatoid arthritis that could interfere with the study.

What is being tested?

The study is examining if repairing the subscapularis muscle during a type of shoulder replacement surgery (reverse shoulder arthroplasty) has better outcomes than not repairing it. Participants will either receive a repair or no repair as part of their surgical procedure.

What are the potential side effects?

Potential side effects may include pain at the surgery site, infection risk, limited range of motion, nerve damage around operated area and complications from anesthesia. Specific side effects related to subscapularis repair have not been detailed but would generally relate to shoulder function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a shoulder replacement with the Arthrex system.

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I am between 18 and 100 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had shoulder surgery that involved altering the subscapularis tendon.

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I have had a shoulder infection.

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I am unable to make decisions for myself.

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I have a recent or poorly healed shoulder fracture.

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I have a complete tear in my shoulder muscle.

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My shoulder socket is too damaged for certain types of shoulder surgery.

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My deltoid muscle does not work.

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I have damage to the nerve in my armpit area.

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I have rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints. for reporting.