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New treatment option for Rotator Cuff Tear
Official title Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
ClinicalTrials.gov ID: NCT03617562
What this study is testing
- What it's testing
- Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
- Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and...
- Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
- Irreparable tear determined intra-operatively using standard arthroscopic techniques
- Informed consent obtained
You likely can't join if
- Absence of subscapularis muscle insertion, or irreparable subscapularis tear
- Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
- Acute tears (within 6 months)
- Neurologic injury causing paralysis of affected shoulder / arm
- Any previous surgery to the affected shoulder
- Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
See the full eligibility criteria
- Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
- Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
- Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
- Irreparable tear determined intra-operatively using standard arthroscopic techniques
- Informed consent obtained
- Absence of subscapularis muscle insertion, or irreparable subscapularis tear
- Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
- Acute tears (within 6 months)
- Neurologic injury causing paralysis of affected shoulder / arm
- Any previous surgery to the affected shoulder
- Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
- Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.)
- Are there any non-orthopedic comorbidities that put the patient at significant risk?
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.