Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Обзор

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.

Вмешательства

• Процедура Rotator cuff repairs with BioEnthesis augmentation
  Rotator cuff repair using BioEnthesis allograft patch
• Процедура Rotator cuff repairs without BioEnthesis augmentation
  Rotator cuff repair using standard of care sutures and anchors

Первичные конечные точки

• Rates of re-tear [Срок оценки: Post-operation at 3-months, 6-months, and 12-months]

Вторичные конечные точки (12)

• Change in the Visual Analogue Scale (VAS) from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months]
• Change in the return to activities of daily living (ADL) from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months]
• Change in the Concomitant medications (ConMeds) from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months]
• Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 6-months, and 12-months]
• Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 6-months, and 12-months]
• Change in the Constant-Murley Score from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 6-months, and 12-months]
• Change in the shoulder immobilization status from before surgery to after surgery [Срок оценки: Post-operation at 3-months, 6-months, and 12-months]
• Change in strength measurements from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 6-months and 12-months]
• Change in range of motion measurements from before surgery to after surgery [Срок оценки: Pre-operation (baseline) and then post-operation at 6-months and 12-months]
• Number of medical events/adverse events after surgery [Срок оценки: Day of surgery and post-operation at 3-months, 6-months, and 12-months]
• Cumulative number of steroid injections after surgery [Срок оценки: Post-operation at 3-months, 6-months, and 12-months]
• Number of unscheduled visits after surgery [Срок оценки: Post-operation at 3-months, 6-months, and 12-months]

Критерии участия

Критерии включения

• 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)
• Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s)

Критерии исключения

• 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 (such as 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• 10th Medical Group - Air Force Academy — Air Force Academy
• Walter Reed National Military Medical Center — Bethesda
• University of North Carolina Chapel Hill — Chapel Hill
• Duke University — Durham
• Brooke Army Medical Center — San Antonio

Идентификаторы

NCT: NCT06289686 · C.2023.080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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