Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

Официальное название

Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

Обзор

The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery

Вмешательства

• Другое ActiveMatrix® Dosage A
  This group will receive ActiveMatrix® (AM) product dosage A (1cc AM diluted to 3cc with saline)
• Другое ActiveMatrix® Dosage B
  Group 2 will receive ActiveMatrix® product dosage B (2cc AM diluted to 3cc with saline)
• Процедура Saline injection
  Group 3 will receive saline injection

Первичные конечные точки

• Change in Sugaya score as measured by Magnetic Resonance Imaging (MRI) [Срок оценки: 6 months post surgery , 12 months post surgery]

Вторичные конечные точки (4)

• Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer [Срок оценки: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months]
• Change in shoulder function as assessed by the American Shoulder and Elbow Surgeons Shoulder Score (ASES) [Срок оценки: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months]
• Change in pain intensity as assessed by the Visual Analog Scale (VAS) [Срок оценки: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months]
• Change in pain and functional disability as assessed by the Shoulder Pain and Disability Index (SPADI) [Срок оценки: baseline, 4weeks, 3 months, 6 months 9 months, and 12 months]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 1-2 tendon full thickness reparable rotator cuff tendon tear(s)

Reparable tear defined as:

a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.

Full-thickness tear 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

• Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
• Have no contraindications or allergies to the treatment administered
• Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
• Able and willing to comply with the post-operative physical therapy and study follow-up schedule

Критерии исключения

• Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
• Prior surgery for bone defects requiring bone implantation in the index shoulder,
• Steroid injection into the index shoulder within 6 weeks of enrollment.
• Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
• Calcific tendonitis in the index shoulder,
• Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
• Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
• History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
• History of malignant tumor and osseous metastatic disease,
• History of heterotopic ossification,
• History of chronic pain disorders (i.e., fibromyalgia),
• Current substance abuse (drug or alcohol), by the investigator's judgment,
• For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study,
• Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
• Currently involved in any injury litigation or workers compensation claims,
• has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05894265 · HSC-MS-23-0312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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