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Ortho-R for Rotator Cuff Repair
Phase 1 & 2
Recruiting
Research Sponsored by Ortho Regenerative Technologies Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgically sterilized, or
Subject is ≥40 to ≤75 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-operative 3,6, and 12 months
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 40-75 with a primary symptomatic rotator cuff tear (1.5 to 4 cm) that can be repaired arthroscopically, who have tried at least two conservative treatments without success or are experiencing severe symptoms. Participants must not use NSAIDs around the surgery and follow-up visits, agree to contraception if of reproductive capacity, and commit to all study visits.Check my eligibility
What is being tested?
The trial is testing Ortho-R/PRP in combination with standard care for rotator cuff repair against standard care alone. It's a Phase I/II study where participants are randomly assigned to one of the two groups and their progress will be compared over a period of 12 months.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally PRP therapy may cause pain at the injection site, tissue damage, infection or nerve injuries. Any surgical procedure carries risks like bleeding, infection or reaction to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone surgical sterilization.
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I am between 40 and 75 years old.
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I have a tear in my shoulder's rotator cuff that can be surgically fixed.
Select...
I am postmenopausal.
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I can move my arm just like my other arm that wasn't affected.
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My rotator cuff tear was fixed using a camera and tools through small cuts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-operative 3,6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-operative 3,6, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complications
Incidence of cuff re-tears
Secondary outcome measures
Analysis of cuff integrity
Change from baseline Constant-Mulrey Score
Change from baseline Euro Quality of Life five questionnaire EQ-5D-5L
+3 moreOther outcome measures
Hematology testing Comprehensive Metabolic panel
Whole blood and PRP (Plasma Rich Platelets) to be collected
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational Arm with Ortho-R/PRPExperimental Treatment1 Intervention
Using a double row, Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) with Ortho-R/PRP combination
Group II: Control Arm Standard of Care without Ortho-R/PRPActive Control1 Intervention
Using the Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) without Ortho-R/PRP combination
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,645 Total Patients Enrolled
Ortho Regenerative Technologies IncLead Sponsor
ChitogenX IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.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 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 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 have a known nerve or muscle condition.My rotator cuff tear was fixed using a camera and tools through small cuts.I have a bone condition like Paget's disease or osteoporosis.I have a diagnosed collagen disorder like lupus or rheumatoid arthritis.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.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Arm with Ortho-R/PRP
- Group 2: Control Arm Standard of Care without Ortho-R/PRP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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