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

NCT05333211 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: ORT-2020-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Rotator Cuff Tears

Keywords

Shoulder Repair

Outcome Measures

Primary Outcomes (10)

• Complications

  Assess adverse events and serious adverse events and patient safety

  Day of surgery

• Complications

  Assess adverse events and serious adverse events and patient safety

  post-operative 10 days

• Complications

  Assess adverse events and serious adverse events and patient safety

  post-operative 1 month

• Complications

  Assess adverse events and serious adverse events and patient safety

  post-operative 3 months

• Complications

  Assess adverse events and serious adverse events and patient safety

  post-operative 6 months

• Complications

  Assess adverse events and serious adverse events and patient safety

  post-operative 12 months

• Incidence of cuff re-tears

  Perform shoulder exam

  post-operative 10 days

• Incidence of cuff re-tears

  Perform shoulder exam and MRI to determine rate of re-tears

  post-operative 3 months

• Incidence of cuff re-tears

  Perform shoulder exam and MRI to determine rate of re-tears

  post-operative 6 months

• Incidence of cuff re-tears

  Perform shoulder exam and MRI to determine rate of re-tears

  post-operative 12 months

Secondary Outcomes (6)

• Change from baseline Visual Analog Scale Score VAS

  Baseline, Post-operative 10 days, and 1,3,6, and 12 months

• Change from baseline Euro Quality of Life five questionnaire EQ-5D-5L

  Baseline, post-operative 3,6, and 12 months

• Change from baseline Constant-Mulrey Score

  Baseline, post-operative 3,6, and 12 months

• Change from baseline Penn Shoulder Score

  Baseline, post-operative 3,6, and 12 months

• Western Ontario Rotator Cuff Index

  Baseline, post-operative 3,6, and 12 months

Other Outcomes (2)

• Hematology testing Comprehensive Metabolic panel

  Prior to surgery to confirm eligibility

• Whole blood and PRP (Plasma Rich Platelets) to be collected

  Baseline, post-operative 3,6, and 12 months

Study Arms (2)

Investigational Arm with Ortho-R/PRP

EXPERIMENTAL

Using a double row, Trans-osseous Equivalent Rotator Cuff Repair Technique (TOE) with Ortho-R/PRP combination

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

Interventions

Ortho-R/PRP DRUG

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.

Investigational Arm with Ortho-R/PRP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• ChitogenX Inc: lead
• MCRA: collaborator

Study Sites (9)

American Sports Medicine Institute

Birmingham, Alabama, 35205, United States

RECRUITING

Tucson Orthopedics

Tucson, Arizona, 85712, United States

RECRUITING

Holy Cross Orthopedic Research Institute

Fort Lauderdale, Florida, 33334, United States

RECRUITING

The Orthopaedic Research Foundation, Inc.

Indianapolis, Indiana, 46074, United States

RECRUITING

Johns Hopkins University

Columbia, Maryland, 21045, United States

RECRUITING

University of Buffalo Orthopaedic & Sports Medicine

Buffalo, New York, 14226, United States

RECRUITING

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

University Orthopedics Center

State College, Pennsylvania, 16801, United States

RECRUITING

OrthoVirginia

Richmond, Virginia, 23294, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Ana P Villagomez

CONTACT

5713445114; avillagomez@mcra.com

Catherine Gurgol

CONTACT

202.742.3866; cgurgol@mcra.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 18, 2022
• Study Start: July 26, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)