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Bioinductive Patch for Rotator Cuff Tears
Study Summary
This trial is testing a new way to fix a rotator cuff tear, to see if it results in a higher rate of repair integrity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am scheduled for a shoulder surgery to repair the rotator cuff.I am 18 years old or older.I have had surgery on my shoulder before, but only for diagnosis.I have a partial tear in my shoulder's rotator cuff.I have a small tear in my shoulder tendon.I have tried physical therapy for over 6 weeks without improvement.I have a tear in my shoulder's subscapularis tendon.I have a medium to massive tear in my shoulder's rotator cuff, confirmed by imaging.I currently have an infection.I am scheduled for a specific shoulder surgery.I have a recent and sudden shoulder injury.I have long-term shoulder tendon tears.I have cancer.I have an autoimmune or rheumatologic disorder like rheumatoid arthritis.
- Group 1: Control Group
- Group 2: Study Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the regulatory body given clearance to arthroscopic rotator cuff repair?
"The arthroscopic rotator cuff repair has been approved and its safety thus rated a 3 on our rating system. This is because it's classified as a Phase 4 trial at Power."
Are there currently any opportunities to partake in this research endeavor?
"The clinical trial is currently in the recruitment phase, as evidenced by the information published on clinicaltrials.gov. This medical experiment was initiated on August 16th 2022 and has been revised most recently on October 17th 2022."
What is the population size of this experimentation?
"Yes, according to the information hosted on clinicaltrials.gov, this study is currently enlisting volunteers. It was posted on August 16th 2022 and amended most recently on October 17th 2022; 78 patients need to be signed up from a single site."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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