Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT05333211

Run by

ChitogenX Inc

People needed

78

Starts

2022-07-26

Expected to finish

2024-05-01

Last updated by the study team

2023-03-21

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• American Sports Medicine Institute — Birmingham, Alabama, United States (enrolling)
• Tucson Orthopedics — Tucson, Arizona, United States (enrolling)
• Holy Cross Orthopedic Research Institute — Fort Lauderdale, Florida, United States (enrolling)
• The Orthopaedic Research Foundation, Inc. — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins University — Columbia, Maryland, United States (enrolling)
• University of Buffalo Orthopaedic & Sports Medicine — Buffalo, New York, United States (enrolling)
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (enrolling)
• University Orthopedics Center — State College, Pennsylvania, United States (enrolling)
• OrthoVirginia — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.