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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
If subject is female or male, and of reproductive capacity, subject must be:
Postmenopausal.
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 below
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I am using or willing to use birth control if I can have children.
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I have gone through menopause.
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My rotator cuff tear was fixed using a camera and tools through small cuts.
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I have a tear in my shoulder's rotator cuff that can be surgically fixed.
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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.
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I am postmenopausal.
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I can attend all required follow-up visits.
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My rotator cuff tear was fixed using a camera and tools through small cuts.
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I can move my arm just like my other arm that wasn't affected.
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I've tried at least 2 treatments for my shoulder pain for over 6 weeks without success.
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My rotator cuff tear was fixed using a camera and tools through small cuts.
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I am between 40 and 75 years old.
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I agree not to take NSAIDs or Paracetamol around my surgery and follow-up visits.
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My arm moves as well as it did before my shoulder was affected.
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I have undergone surgery for sterilization.
Select...
My arm moves as well as it did before my shoulder was affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-operative 3,6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-operative 3,6, and 12 months for reporting.

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 more
Other 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

Find a Location

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

Ortho-R/PRP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05333211 — Phase 1 & 2
Rotator Cuff Tears Research Study Groups: Investigational Arm with Ortho-R/PRP, Control Arm Standard of Care without Ortho-R/PRP
Rotator Cuff Tears Clinical Trial 2023: Ortho-R/PRP Highlights & Side Effects. Trial Name: NCT05333211 — Phase 1 & 2
Ortho-R/PRP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333211 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Holy Cross Orthopedic Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
~29 spots leftby Mar 2025