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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
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

Subscap Trial 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.Check my eligibility
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.See study design
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.

Subscap Trial 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.

Subscap Trial Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Shoulder
Secondary outcome measures
American Shoulder and Elbow Surgeons (ASES) subjective survey
Return to Work Form
Simple Shoulder Test (SST) questionnaire
+7 more

Subscap Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reverse Shoulder Arthroplasty with subscapularis repairExperimental Treatment1 Intervention
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
Group II: Reverse Shoulder Arthroplasty without subscapularis repairActive Control1 Intervention
The subscapularis will not be repaired.

Find a Location

Who is running the clinical trial?

Arthrex, Inc.Lead Sponsor
44 Previous Clinical Trials
29,748 Total Patients Enrolled

Media Library

Repair of the subscapularis (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT05438914 — N/A
Cuff Tear Arthropathy Research Study Groups: Reverse Shoulder Arthroplasty without subscapularis repair, Reverse Shoulder Arthroplasty with subscapularis repair
Cuff Tear Arthropathy Clinical Trial 2023: Repair of the subscapularis Highlights & Side Effects. Trial Name: NCT05438914 — N/A
Repair of the subscapularis (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research initiative include individuals under the age of forty-five?

"This trial is open to any individuals aged 18-100, with a separate cohort of 10 participants younger than 18 and 96 elderly patients."

Answered by AI

Who has the qualifications to partake in this research endeavor?

"Qualifying patients may partake in this trial if they are aged 18-100 with rotator cuff tear arthropathy. Up to 134 people will be accepted into the program."

Answered by AI

Are there any available opportunities for involvement in this experiment?

"Clinicaltrials.gov informs us that this medical trial is actively enlisting participants. It was originally published on September 14th 2022 and then revised a week later, on the 21st."

Answered by AI

What is the cap on enrollees for this experiment?

"Affirmative. According to clinicaltrials.gov, this experimental procedure was first posted on September 14th 2022 and is still actively recruiting participants. There are 2 sites for 134 enrollees in total."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Southern Oregon Orthopedics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Subscapularis Repair in Reverse Shoulder Arthroplasty
2022. "Subscapularis Repair in Reverse Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438914.
~63 spots leftby Sep 2025
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