Evaluating the Use of a Bioinductive Graft in Treating Massive Rotator Cuff Tears
Launched by IVAN WONG · Jan 29, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for large rotator cuff tears, which are common shoulder injuries that can cause pain and limit movement. The trial will compare two surgical methods: one where a special graft made from purified collagen is used to repair the tear, and another where only damaged tissue is removed, a process called debridement. The goal is to find out which method helps patients recover better and reduces the chances of the tear coming back after one year.
To be eligible for the trial, participants must be adults over 18 years old with a confirmed large rotator cuff tear of more than 3 centimeters, as shown on an MRI scan. Certain conditions, like uncontrolled diabetes or other shoulder issues, may prevent someone from joining. If eligible, participants can expect to have surgery and will be monitored for their recovery, including any changes in pain and shoulder movement. This study aims to provide valuable information on the best treatment options for individuals with massive rotator cuff tears.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Magnetic resonance imaging (MRI) proven diagnosis of a large \>3cm tear of the shoulder rotator cuff in a competent adult (\>18 years of age).
- Exclusion Criteria:
- • Patients with subscapular tear
- • Glenohumeral osteoarthritis
- • A normalized WORC score \>70 (where scores range between 0-100, and 100 is the best outcome)
- • Uncontrolled diabetes (Hgb A1C \>7%)
- • Pregnancy
- • Presence of local or systemic infection
- • Inability to cooperate with and/or comprehend post-operative instructions
- • Nonvascular surgical sites (MRI proven)
- • Poor nutritional state (Alb \<30 g/L)
- • Cancer
- • Paralysis of the shoulder
- • Contracture of the shoulder
- • Presence of cuff tear arthropathy or osteoarthritis of the shoulder
- • Patients unable to provide informed consent for the study
About Ivan Wong
Ivan Wong is a dedicated clinical trial sponsor with a strong focus on advancing medical research and development. With a commitment to innovative solutions and patient-centered approaches, Ivan Wong collaborates with healthcare professionals and research institutions to facilitate robust clinical trials. By leveraging a comprehensive understanding of regulatory requirements and clinical best practices, the organization aims to accelerate the discovery of new therapies and improve health outcomes. Ivan Wong's expertise in trial design, patient recruitment, and data analysis underscores its mission to contribute significantly to the evolving landscape of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Halifax, Nova Scotia, Canada
Patients applied
Trial Officials
Ivan Wong, MD
Principal Investigator
Orthopaedic Surgeon
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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