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Procedure

Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Rotator Cuff Tears

N/A

Recruiting

Research Sponsored by Robert J. Gillespie

Eligibility Criteria Checklist

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

Must have

Age range: ≥18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is comparing pain and functional outcomes of two surgical modalities for irreparable rotator cuff tears, partial repair alone and partial repair with superior capsule reconstruction. The hypothesis is that there is no difference in pain and functional outcomes between the two surgeries.

Who is the study for?

This trial is for adults over 18 with irreparable rotator cuff tears, as seen on MRI. It's not for those with severe joint issues (Hamada grade ≥3), arthritis visible on X-rays, shoulder infections, neurological problems affecting the shoulder, workers' compensation claims, smokers, or if a complete repair is possible during surgery. Pregnant women and individuals who are illiterate or don't speak English are also excluded.Check my eligibility

What is being tested?

The study compares two surgical treatments for serious rotator cuff injuries: partial rotator cuff repair alone versus the same repair with superior capsule reconstruction (SCR). Pain and function will be measured at multiple times post-surgery to see which method works better. The trial will also use MRI to check how often each treatment fails after one year.See study design

What are the potential side effects?

While specific side effects aren't listed here, surgeries like these can typically result in pain at the site of operation, swelling, infection risk increase around the operated area and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

American Shoulder and Elbow Society (ASES) score

Pain

Patient Reported Outcomes Measurement Information Systems (PROMIS)-29

+1 more

Secondary outcome measures

Graft/repair integrity via magnetic resonance imaging

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Superior Capsular ReconstructionActive Control1 Intervention

Group II: Partial Rotator Cuff RepairPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Robert J. GillespieLead Sponsor

Midwest Orthopaedics at RushOTHER

2 Previous Clinical Trials

50 Total Patients Enrolled

University Hospitals Cleveland Medical CenterOTHER

318 Previous Clinical Trials

340,130 Total Patients Enrolled

2 Trials studying Rotator Cuff Tears

44 Patients Enrolled for Rotator Cuff Tears

Media Library

Partial Rotator Cuff Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04742452 — N/A

Rotator Cuff Tears Research Study Groups: Superior Capsular Reconstruction, Partial Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial 2023: Partial Rotator Cuff Repair Highlights & Side Effects. Trial Name: NCT04742452 — N/A

Partial Rotator Cuff Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742452 — N/A

Frequently Asked Questions

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

Are people between any age range being enrolled in this investigation?

"Applicants for this clinical trial must be between the ages of 18 and 89. There are 10 trials dedicated to those below 18 years old, as well as 94 specifically catering to individuals 65 or older."

Answered by AI

Would I be eligible to participate in this clinical experiment?

"This medical investigation is obtaining 105 applicants with rotator cuff tears between the ages of 18 and 89."

Answered by AI

Is this medical research accepting new participants at present?

"The clinical trial is recruiting participants, as per the information available on clinicaltrials.gov. The initial posting was made on November 24th 2020 and the most recent update occurred on November 28th 2022."

Answered by AI

How many participants have been accepted into this experiment?

"Indeed, the particulars of this clinical trial visible on clinicaltrials.gov demonstrate that recruitment is underway. It was initially posted November 24th 2020 and most recently modified November 28th 2022, with a goal of recruiting 105 sufferers from 3 separate locations."

Answered by AI

Recent research and studies

Journal of Shoulder and Elbow SurgeryJournal

Arthroscopic Tenotomy of the Long Head of the Biceps in the Treatment of Rotator Cuff Tears: Clinical and Radiographic Results of 307 Cases

Walch, Gilles, T. Bradley Edwards, Aziz Boulahia, Laurent Nové-Josserand, Lionel Neyton, and Istvan Szabo. 2005. “Arthroscopic Tenotomy of the Long Head of the Biceps in the Treatment of Rotator Cuff Tears: Clinical and Radiographic Results of 307 Cases”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2004.07.008.

Arthroscopy: The Journal of Arthroscopic & Related SurgeryJournal

Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft

Denard, Patrick J., Paul C. Brady, Christopher R. Adams, John M. Tokish, and Stephen S. Burkhart. 2018. “Preliminary Results of Arthroscopic Superior Capsule Reconstruction with Dermal Allograft”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2017.08.265.

Orthopaedic Journal of Sports MedicineJournal

Nonarthroplasty Surgical Treatment Options for Massive, Irreparable Rotator Cuff Tears

Carver, Trevor J., Matthew J. Kraeutler, John R. Smith, Jonathan T. Bravman, and Eric C. McCarty. 2018. “Nonarthroplasty Surgical Treatment Options for Massive, Irreparable Rotator Cuff Tears”. Orthopaedic Journal of Sports Medicine. SAGE Publications. doi:10.1177/2325967118805385.

Journal of the American Academy of Orthopaedic SurgeonsJournal