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Ortho-R for Rotator Cuff Repair
Study Summary
This trial will compare a new combination treatment for rotator cuff repair against the current standard of care, assessing the results after 12 months.
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I am using or willing to use birth control if I can have children.I do not have a mental condition that affects my decision-making.I am capable of having children and will follow the study's birth control requirements.You are not currently engaging in sexual activity.I have gone through menopause.My rotator cuff tear was fixed using a camera and tools through small cuts.My shoulder has a specific medical condition.I am scheduled for, or will schedule, rotator cuff repair on my other shoulder during this study.I have a problem with my shoulder muscle.I have a tear in my shoulder's rotator cuff that can be surgically fixed.I have had issues with my shoulder muscles.I need surgery to fix or rebuild my shoulder.I have received a cortisone shot within the last 3 months.I do not have unstable blood pressure or severe infection in my blood.I have undergone surgical sterilization.I have lost ligaments.I am between 40 and 75 years old.I agree not to take NSAIDs or Paracetamol around my surgery and follow-up visits.I have recently had a fever or been ill.I have a partial tear in my shoulder's rotator cuff.I have a tear in my shoulder's rotator cuff that can be surgically fixed.I am postmenopausal.I am not currently in another clinical study and haven't been in one for the last 30 days.My muscles have significant fatty infiltration.I have had a shoulder dislocation in the last 5 years.I have an infection in or around my shoulder.I have stiffness from frozen shoulder.I've tried at least 2 treatments for my shoulder pain for over 6 weeks without success.I can move my arm just like my other arm that wasn't affected.I can attend all required follow-up visits.My rotator cuff tear was fixed using a camera and tools through small cuts.I have had surgery on my shoulder tendon or at least 2 steroid shots in the same shoulder.I do not have any conditions that could affect healing, like active cancer or autoimmune diseases.My shoulder arthritis is severe, graded over 2.I've tried at least 2 treatments for my shoulder pain for over 6 weeks without success.I have a known nerve or muscle condition.My rotator cuff tear was fixed using a camera and tools through small cuts.I am between 40 and 75 years old.I agree not to take NSAIDs or Paracetamol around my surgery and follow-up visits.My arm moves as well as it did before my shoulder was affected.I have a bone condition like Paget's disease or osteoporosis.I have a diagnosed collagen disorder like lupus or rheumatoid arthritis.I have undergone surgery for sterilization.I have anemia.I have a condition that affects how my blood clots.I am at high risk for bleeding or infection after surgery due to my condition or medications.I have no history of major health issues like heart disease, severe lung problems, uncontrolled mental health conditions, or active infections.I have cancer that affects my bones or muscles, or another type of cancer that hasn't been in remission for at least 5 years.My diabetes is not under control, or I need insulin.I have a health issue that prevents me from having planned surgery.I have not taken steroids or immune suppressors in the last 3 months.My arm moves as well as it did before my shoulder was affected.
- Group 1: Investigational Arm with Ortho-R/PRP
- Group 2: Control Arm Standard of Care without Ortho-R/PRP
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is participation in this medical study still possible?
"All evidence points to this medical trial actively recruiting patients; it was posted on June 1st 2022 and most recently revised on the 21st of that same month."
What is the scope of individuals involved in this research?
"The sponsor, MCRA, necessitates 78 eligible patients to commence the study. These individuals will be sourced from two sites - Holy Cross Orthopedic Research Institute in Fort Lauderdale, Florida and OrthoVirginia in Richmond, Virginia."
What type of person should be considered for this research project?
"This clinical trial is searching for 78 individuals between the ages of 40-75 who have recently suffered rotator cuff tears. Eligibility criteria includes having attempted conservative treatments (pain meds, chiropractic care, physical therapy etc.), being actively contraception or postmenopausal, and a willingness to not use any NSAIDs prior to surgery or followup appointments."
How many healthcare facilities are participating in this experiment?
"The 5 active trial sites are Holy Cross Orthopedic Research Institute in Fort Lauderdale, OrthoVirginia in Richmond, and Tucson Orthopedics in Tucson along with two other medical centres."
Does the enrollment criteria for this clinical trial include individuals over 35 years old?
"Eligibility for this clinical trial requires that participants are age 40 or above and no more than 75 years old."
What are the primary aims of this medical experiment?
"This clinical trial will assess the rate of cuff re-tears over a 12 month period post operation. Secondary outcomes include change from baseline in EQ-5D-5L scores, which measure mobility, self care, usual activities and more; MRI imaging to evaluate cuff integrity; as well as VAS score assessments of patient shoulder pain (0 - 10)."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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