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MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation
Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.
Conditions:
🦠 Rotator Cuff Tears 🦠 Rotator Cuff Injuries 🦠 Surgery
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Bethesda, Maryland, United States
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * DEERS-eligible
    • * Adults, between the ages of 18-65 (inclusive)
    • * Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension)
    • * Ability to undergo surgery to repair rotator cuff tear
    • * Willingness to commit to study procedures including study intervention and a 12-month follow-up
    • * Fluency in speaking, reading, comprehending English
    • * 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border)

    Exclusion Criteria:

    • * Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy)
    • * Inability to receive an MRI
    • * Current (within the past 6 months) tobacco user
    • * Unwilling to remain tobacco free for the duration of the study
    • * Current lower limb injuries requiring walking assist devices such as crutches and walkers
    • * Diagnosed with systemic arthritis
    • * Significant neck pathology
    • * Active joint or systemic infection
    • * Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial)
    • * Significant muscle paralysis of the shoulder girdle
    • * Currently pregnant or plans to become pregnant during this study
    • * Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter
    • * Inability of the surgeon to repair the tear with less than 1cm of medialization
    • * Evidence of other significant shoulder pathology including Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis.
    • * Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
    • * Major medical illness that would preclude undergoing surgery
    • * Major psychiatric illness or developmental handicap
    • * Goutallier III classification and above
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 February 2024
  • First Submitted that Met QC Criteria 29 February 2024
  • First Posted 4 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024
I'm interested ...!!