Rotator Cuff TearsPhase 1/2NCT05333211
Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®
A Phase 1/2 study testing Ortho-R/PRP in people with Rotator Cuff Tears, run by ChitogenX Inc at 9 sites in United States.
Trial summary
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Ortho-R/PRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 9 sitesUnited States
- Study dates
- 26 Jul 2022to May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is ≥40 to ≤75 years.
- Subject has a primary symptomatic fully repairable rotator cuff tear ranging between 1.5 to 4 cm involving the supraspinatus and/or infraspinatus that is amenable to a TOE repair.
- Subject's rotator cuff tear must be repaired arthroscopically.
- Subject has failed at least 6 weeks of conservative management, from symptoms onset, of at least 2 conservative treatments including oral pain medications [including but not limited to non-narcotics, NSAIDs, acetaminophen as per labeling of the medications], chiropractic care, rest and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of rotator cuff tear injuries; or demonstrates the presence of unacceptable progressive symptoms or signs of acute functional deficit or intractable pain for which conservative care as noted above is otherwise not indicated.
- Subject has full passive movement of the arm comparable to the normal unaffected shoulder.
- If subject is female or male, and of reproductive capacity, subject must be:
Show all 13Show fewer
- Actively practicing a contraception method throughout the study,
- Practicing abstinence,
- Surgically sterilized, or
- Postmenopausal.
- Subject agrees to not use any NSAIDs e.g., naproxen, high dose aspirin, ibuprofen, Meloxicam, Diclofenac, etc., and/or Paracetamol for 5 days prior to baseline, 1 week (7 days) prior to surgery and for 6 weeks post-surgery with the exception of low dose aspirin. In addition, subject must agree to not use these products within 5 days of each follow-up visit starting with the 3-month visit, so as not to introduce confounding factors for assessments.
- Subject is willing and able to return for protocol required follow-up visits.
- Subject is willing and able to voluntarily sign the IRB approved Informed Consent.
Who cannot join
- Subject with body mass index (BMI) ≤20 and ≥35.
- Subject has any of the following conditions in the index shoulder:
- Received a cortisone injection within 3 months prior to Surgery (Day 0)
- Loss of ligaments
- Known neuromuscular or neurovascular compromise.
- Deltoid deficiency (defect, tear, palsy).
Show all 49Show fewer
- Samilson-Prieto Grade > 2 for osteoarthritis of glenohumeral joint.
- Subject has a Goutallier Grade ≥3 fatty infiltration.
- History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination or radiographic findings.
- Subject has a partial rotator cuff tear.
- Subject's condition is bilateral and rotator cuff repair is scheduled or is to be scheduled over the course of this study for the contralateral shoulder.
- Subject has had prior or current involvement of the subscapularis or teres minor.
- Subject requires concurrent fracture repair or reconstruction of the index shoulder.
- Subject has a known allergy to shellfish.
- Subject has any of the following conditions:
- thrombocytopenia,
- anemia,
- platelet dysfunction syndrome,
- hemodynamic instability or septicemia,
- Subject has had a recent fever or illness.
- Subject has prior rotator cuff tendon repair, or ≥2 prior corticosteroid injections in the index shoulder.
- Subject has an underlying metabolic bone disease (e.g., Paget's disease, fibrous dysplasia, osteoporosis).
- Subject is at a higher risk for post-surgical bleeding (e.g., bleeding disorders; taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; has a severe infection or recent use of systemic steroids).
- Subject has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
- Subject has any disease, condition or surgery which in the opinion of investigator might impair healing, such as an active malignancy, history of metastatic malignancy, inflammatory or auto-immune based joint disease.
- Subject has evidence of a systemic infection, infection of the index shoulder or infection of the shoulder joint or overlying tissue such as septic arthritis, overlying cellulitis, or adjacent osteomyelitis.
- Subject has history of peripheral or central vascular disease, renal dysfunction, liver disease, COPD, uncontrolled asthma, coagulopathies, cancers aside from basal cell carcinomas, uncontrolled neurological conditions, ongoing HIV, hepatitis B or C, active tuberculosis, recurrent infections, uncontrolled cardiac arrhythmias, or mental/emotional disorders that are not well controlled.
- Subject has diagnosed musculoskeletal cancer, or any other diagnosed cancer not on long term remission (e.g., at least 5 years or negative biopsy at last exam) except basal cell carcinoma.
- Subject who demonstrates any clinically significant abnormality* for any of the following hematology testing within 30 days (± 2days) of enrollment:
- Complete blood count with differential
- Blood chemistry [comprehensive metabolic panel including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, creatinine, and CRP), coagulation profile (including international normalized ration (INR), prothrombin time (PT), activated partial thromboplastin time (APTT)]
- Thrombin Time (TT) and
- Fibrinogen (FIB).
- Subject who demonstrates any clinically significant abnormality* for any of the following vital signs within 30 days (± 2days) of enrollment:
- Systolic BP > 160 mmHg or < 90 mmHg
- Pulse > 100 bpm or < 60 bpm
- Respiratory Rate > 25 or < 10
- O2 saturation < 90% on Room Air.
- Subject with any mental or psychological disorder that would impair their decisional capability.
- Subject has uncontrolled, defined as HB A1c of > 8.0%, or insulin-dependent diabetes.
- Subject with a documented history of substance abuse within six months of treatment.
- Subject has known claustrophobia and/or contraindications to MR imaging.
- Subjects with any clinically significant finding that, in the investigator's judgment, would place the subject at health risk, impact the study, or affect the completion of the study.
- Subject has any medical problem that precludes the subject from undergoing elective surgery.
- Subjects who are participating concurrently in another clinical study or have participated in a clinical study within 30 days of surgery (Day 0) or intend to during the course of the study.
- Subject is pregnant.
- Subject taking systemic steroids (excluding inhalers) and/or auto-immune suppressor drugs within 3 months prior to surgery (Day 0) or who are at risk of needing systemic steroids, such as for asthma.
- Subjects who are currently involved in any injury litigation relating to the index shoulder.
- Subjects with stiffness due to Adhesive Capsulitis.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
American Sports Medicine Institute
Birmingham, Alabama, 35205
Ashley Gilmore, ashley.gilmore@ascension.org
Ariel Kidwell, ArielK@asmi.org
- Recruiting
University of Buffalo Orthopaedic & Sports Medicine
Buffalo, New York, 14226
Mary Bayers-Thering, MBayersThering@KaleidaHealth.org
Matthew DiPaola, MD
- Recruiting
Johns Hopkins University
Columbia, Maryland, 21045
Zachary Pearson, zpearso1@jhu.edu
Uma Srikumaran, MD
- Recruiting
Holy Cross Orthopedic Research Institute
Fort Lauderdale, Florida, 33334
Janice Schuck, Janice.Schuck@holy-cross.com
Jonathan Levy, MD
- Recruiting
The Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, 46074
Melanie Glover, mglover@orthoindy.com
Ainsley Baker, abaker@orthoindy.com
- Recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Thema Nicholson, Thema.Nicholson@rothmanortho.com
Joseph Abboud, MD
- Recruiting
OrthoVirginia
Richmond, Virginia, 23294
Brendan Baggot, BrendBrendan.Baggot@orthovirginia.com
William Nordt, MD
- Recruiting
University Orthopedics Center
State College, Pennsylvania, 16801
Jill Fremberg, jfremberg@uoc.com
Edwin Rogusky, MD
- Recruiting
Tucson Orthopedics
Tucson, Arizona, 85712
Nebojsa Skrepnik, NSkrepnik@tucsonortho.com
Karla Tovar, ktovar@tucsonortho.com
About this study
Official title: A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared With Standard of Care
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.
Read the detailed description
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Three subjects will be treated with the investigational arm and will service as training cases. The next 2 randomized intervention cases will be staggered by 48-96 hours and observed for adverse events. Randomized enrollment will then be initiated for all participating sites. Assessment of subjects with Ortho-R/PRP combination with be compared to subjects not randomized to Ortho-R/PRP group receiving standard of care who undergo rotator cuff repair surgery. Patients will be assessed by collecting patient-reported outcomes, MRI, incidence of rotator cuff re-tears, hematology and all adverse events. Data from pre-operative evaluation, day of surgery, and post-operative at 10 days, and 1,3, 6 and 12 months will be collected.
- Conditions
- Rotator Cuff Tears
- Being tested
- Ortho-R/PRP
- Keywords
- Shoulder Repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho-R/PRPDrug
Ortho-R® is a freeze-dried drug/biologic combination product containing a chitosan component and trehalose, a disaccharide that acts as a lyoprotectant during the lyophilization process and calcium chloride, which acts as a PRP coagulation agent.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm with Ortho-R/PRP | Experimental | Using a double row, Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) with Ortho-R/PRP combination Receives: Drug: Ortho-R/PRP |
| Control Arm Standard of Care without Ortho-R/PRP | No intervention | Using the Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) without Ortho-R/PRP combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Assess adverse events and serious adverse events and patient safety
Measured: Day of surgery
Complications
Assess adverse events and serious adverse events and patient safety
Measured: post-operative 10 days
Complications
Assess adverse events and serious adverse events and patient safety
Measured: post-operative 1 month
Complications
Assess adverse events and serious adverse events and patient safety
Measured: post-operative 3 months
Complications
Assess adverse events and serious adverse events and patient safety
Measured: post-operative 6 months
Complications
Assess adverse events and serious adverse events and patient safety
Measured: post-operative 12 months
Incidence of cuff re-tears
Perform shoulder exam
Measured: post-operative 10 days
Incidence of cuff re-tears
Perform shoulder exam and MRI to determine rate of re-tears
Measured: post-operative 3 months
Incidence of cuff re-tears
Perform shoulder exam and MRI to determine rate of re-tears
Measured: post-operative 6 months
Incidence of cuff re-tears
Perform shoulder exam and MRI to determine rate of re-tears
Measured: post-operative 12 months
Secondary outcomes (6)
Change from baseline Visual Analog Scale Score VAS
Assessment of patients shoulder pain 0-10, 10 being the worst
Measured: Baseline, Post-operative 10 days, and 1,3,6, and 12 months
Change from baseline Euro Quality of Life five questionnaire EQ-5D-5L
Assess the improvement of health in Mobility, Self care, Usual Activities, Pain/Discomfort., Anxiety/Depression and Overall health scale with 100 being the best
Measured: Baseline, post-operative 3,6, and 12 months
Change from baseline Constant-Mulrey Score
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: Baseline, post-operative 3,6, and 12 months
Change from baseline Penn Shoulder Score
Assessment of pain and satisfaction of should pain, This is a patient-reported outcome tool, and the scores range from 0 to 100 with a score of 100 indicating low pain, high satisfaction, and high function.
Measured: Baseline, post-operative 3,6, and 12 months
Western Ontario Rotator Cuff Index
Assessment of symptoms, work, sports and recreational activities. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all.
Measured: Baseline, post-operative 3,6, and 12 months
Analysis of cuff integrity
MRI Magnetic Resonance Imaging of shoulder to determine rate of re-tears
Measured: Baseline, post-operative 3,6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start26 Jul 2022
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChitogenX Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333211
- Sponsor's protocol ID
- ORT-2020-01
- Status last verified
- Jun 2022
- First submitted
- 31 Mar 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared With Standard of Care
- ClinicalTrials.gov ID
- NCT05333211
- Acronym / sponsor ID
- ORT-2020-01
- Conditions
- Rotator Cuff Tears
- Keywords
- Shoulder Repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- ChitogenX IncIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.
Detailed description
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Three subjects will be treated with the investigational arm and will service as training cases. The next 2 randomized intervention cases will be staggered by 48-96 hours and observed for adverse events. Randomized enrollment will then be initiated for all participating sites. Assessment of subjects with Ortho-R/PRP combination with be compared to subjects not randomized to Ortho-R/PRP group receiving standard of care who undergo rotator cuff repair surgery. Patients will be assessed by collecting patient-reported outcomes, MRI, incidence of rotator cuff re-tears, hematology and all adverse events. Data from pre-operative evaluation, day of surgery, and post-operative at 10 days, and 1,3, 6 and 12 months will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm with Ortho-R/PRP | Experimental | Drug: Ortho-R/PRPUsing a double row, Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) with Ortho-R/PRP combination |
| Control Arm Standard of Care without Ortho-R/PRP | No intervention | –Using the Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) without Ortho-R/PRP combination |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is ≥40 to ≤75 years.
- Subject has a primary symptomatic fully repairable rotator cuff tear ranging between 1.5 to 4 cm involving the supraspinatus and/or infraspinatus that is amenable to a TOE repair.
- Subject's rotator cuff tear must be repaired arthroscopically.
- Subject has failed at least 6 weeks of conservative management, from symptoms onset, of at least 2 conservative treatments including oral pain medications [including but not limited to non-narcotics, NSAIDs, acetaminophen as per labeling of the medications], chiropractic care, rest and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of rotator cuff tear injuries; or demonstrates the presence of unacceptable progressive symptoms or signs of acute functional deficit or intractable pain for which conservative care as noted above is otherwise not indicated.
- Subject has full passive movement of the arm comparable to the normal unaffected shoulder.
Key exclusion criteria (49 listed)
- Subject with body mass index (BMI) ≤20 and ≥35.
- Subject has any of the following conditions in the index shoulder:
- Subject has a partial rotator cuff tear.
- Subject's condition is bilateral and rotator cuff repair is scheduled or is to be scheduled over the course of this study for the contralateral shoulder.
- Subject has had prior or current involvement of the subscapularis or teres minor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ortho-R/PRPOrtho-R® is a freeze-dried drug/biologic combination product containing a chitosan component and trehalose, a disaccharide that acts as a lyoprotectant during the lyophilization process and calcium chloride, which acts as a PRP coagulation agent. | Drug | Investigational Arm with Ortho-R/PRP |
Primary outcome
Complications
Time frame: Day of surgery
Assess adverse events and serious adverse events and patient safety
Complications
Time frame: post-operative 10 days
Assess adverse events and serious adverse events and patient safety
Complications
Time frame: post-operative 1 month
Assess adverse events and serious adverse events and patient safety
Complications
Time frame: post-operative 3 months
Assess adverse events and serious adverse events and patient safety
Complications
Time frame: post-operative 6 months
Assess adverse events and serious adverse events and patient safety
Complications
Time frame: post-operative 12 months
Assess adverse events and serious adverse events and patient safety
Incidence of cuff re-tears
Time frame: post-operative 10 days
Perform shoulder exam
Incidence of cuff re-tears
Time frame: post-operative 3 months
Perform shoulder exam and MRI to determine rate of re-tears
Incidence of cuff re-tears
Time frame: post-operative 6 months
Perform shoulder exam and MRI to determine rate of re-tears
Incidence of cuff re-tears
Time frame: post-operative 12 months
Perform shoulder exam and MRI to determine rate of re-tears
6 secondary outcomes
Change from baseline Visual Analog Scale Score VAS
Time frame: Baseline, Post-operative 10 days, and 1,3,6, and 12 months
Change from baseline Euro Quality of Life five questionnaire EQ-5D-5L
Time frame: Baseline, post-operative 3,6, and 12 months
Change from baseline Constant-Mulrey Score
Time frame: Baseline, post-operative 3,6, and 12 months
Change from baseline Penn Shoulder Score
Time frame: Baseline, post-operative 3,6, and 12 months
Western Ontario Rotator Cuff Index
Time frame: Baseline, post-operative 3,6, and 12 months
Analysis of cuff integrity
Time frame: Baseline, post-operative 3,6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ortho-R/PRP in people with Rotator Cuff Tears, run by ChitogenX Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana P Villagomez (5713445114, avillagomez@mcra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Day of surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.