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Procedure

Superior Capsular Reconstruction vs. Partial Repair for Rotator Cuff Tears (SCR Trial)

N/A
Recruiting
Led By Patrick Henry, MD, FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic shoulder pain and/or weakness (regardless of baseline range of motion/pseudoparalysis)
Irreparable tear determined intra-operatively using standard arthroscopic techniques
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post operative
Awards & highlights

SCR Trial Summary

This trial is testing a new technique, called superior capsular reconstruction, to see if it's more effective than the current standard treatment for massive irreparable rotator cuff tears.

Who is the study for?
This trial is for individuals who have massive rotator cuff tears larger than 4 cm, involving the supraspinatus and infraspinatus, that haven't improved after at least three months of non-surgical treatment. Participants must be experiencing shoulder pain or weakness but cannot have had previous surgery on the affected shoulder or certain conditions like advanced joint disease.Check my eligibility
What is being tested?
The study compares two surgical techniques for treating massive irreparable rotator cuff tears: Superior Capsular Reconstruction (SCR) and Partial Rotator Cuff Repair (PRCR). It's a pilot randomized control trial to determine which method is more effective before conducting a larger clinical trial.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks of shoulder surgeries may include infection, nerve damage, stiffness, incomplete tear repair leading to persistent pain or weakness, and complications from anesthesia.

SCR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have shoulder pain or weakness.
Select...
My tear was found to be irreparable during surgery.
Select...
I have a large tear in my shoulder muscles, confirmed by MRI.

SCR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Secondary outcome measures
Complication rate
Constant-Murley Score
EQ-5D
+9 more

SCR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Superior Capsular ReconstructionExperimental Treatment1 Intervention
Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft.
Group II: Partial RepairActive Control1 Intervention
Patients will have a partial repair with residual defect as an established standard procedure.

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonOTHER
195 Previous Clinical Trials
25,354 Total Patients Enrolled
The Ottawa HospitalOTHER
93 Previous Clinical Trials
62,918 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,227 Total Patients Enrolled

Media Library

Partial Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03617562 — N/A
Rotator Cuff Tears Research Study Groups: Superior Capsular Reconstruction, Partial Repair
Rotator Cuff Tears Clinical Trial 2023: Partial Repair Highlights & Side Effects. Trial Name: NCT03617562 — N/A
Partial Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03617562 — N/A

Frequently Asked Questions

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

Am I a valid participant for this research?

"For eligibility in this clinical trial, potential participants must have rotator cuff damage and be between 18 - 65 years old. Approximately 70 individuals are being sought for the experiment."

Answered by AI

How many participants has this clinical investigation recruited?

"Affirmative, clinicaltrials.gov reveals that this experiment is actively seeking subjects. The trial was initially launched on July 18th 2018 and underwent its latest update on October 14th 2021. 70 volunteers need to be recruited for the 2 sites involved in the study."

Answered by AI

Are there any openings for participants in this research endeavor?

"The posted information on clinicaltrials.gov shows that this trial, which was initially launched in July 2018, is actively recruiting participants. The details were last modified October 14th 2021."

Answered by AI

Does this investigation take into account the participation of individuals aged 35 or above?

"This clinical trial offers a cohort of participants aged 18-65. Simultaneously, 10 trials are offered to those younger than 18 and 94 for seniors over 65 years old."

Answered by AI
~20 spots leftby Jul 2026