Augmentation of Arthroscopic Rotator Cuff Repair With Reimplantation of Subacromial Bursa Tissue and Platelet-Rich Plasma
ΕΝΙΣΧΥΣΗ ΑΡΘΡΟΣΚΟΠΙΚΗΣ ΣΥΡΡΑΦΗΣ ΣΤΡΟΦΙΚΟΥ ΠΕΤΑΛΟΥ ΜΕ ΕΠΑΝΕΜΦΥΤΕΥΣΗ ΙΣΤΟΥ ΤΟΥ ΥΠΑΚΡΩΜΙΑΚΟΥ ΘΥΛΑΚΟΥ ΚΑΙ ΠΛΑΣΜΑΤΟΣ ΠΛΟΥΣΙΟΥ ΣΕ ΑΙΜΟΠΕΤΑΛΙΑ
The goal of this observational study is to evaluate the clinical and radiographic outcomes of the biological enhancement of the arthroscopic rotator cuff repair with stem cells from the acromial bursa and PRP in individuals who undergo arthroscopic cuff repair The main question it aims to answer is:
Do the stems cells from the acromial bursa and PRP promote healing and produce better results in arthroscopic cuff repair? Researchers will compare this population to three others the first do bnot receive any biological enchancement, the second receive only stem cells and the third receive only PRP to see if there are any differences.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: ANDRIANI ZAFEIRI, MEDICAL DOCTOR
- Номер телефона: +306933398382
- Электронная почта: andrianizaf@hotmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria Adult patients aged ≥18 years. Patients undergoing arthroscopic rotator cuff repair. Patients with a full-thickness, isolated, primary tear of the supraspinatus tendon.
Patients considered eligible for arthroscopic rotator cuff repair using suture anchors.
Ability and willingness to provide written informed consent. Willingness and ability to comply with the study protocol and scheduled follow-up visits.
Exclusion Criteria Partial-thickness rotator cuff tears. Massive or irreparable rotator cuff tears. Revision rotator cuff repair. Concomitant tears of the subscapularis tendon, infraspinatus tendon, long head of the biceps tendon requiring surgical treatment, or glenoid labrum.
Previous surgery on the affected shoulder. Glenohumeral osteoarthritis or advanced cuff tear arthropathy. Active infection or systemic inflammatory disease affecting the shoulder. Use of other biological augmentation techniques during surgery, such as collagen patch, stem cells, bone marrow aspirate concentrate, or other scaffold-based augmentation.
Inability to provide informed consent. Inability or unwillingness to comply with the postoperative rehabilitation protocol or follow-up schedule.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: GROUP A
(MSCs + PRP): 1 ml of a mixture of subacromial bursa and 3 ml of PRP will be placed in the bone-tendon junction after completion of the arthroscopic suturing
|
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
|
|
Экспериментальный: GROUP B
1 ml of a mixture of subacromial bursal tissue fragments without PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Autologous minced subacromial bursal tissue harvested arthroscopically using a tissue collection device and applied at the bone-tendon interface immediately after rotator cuff repair.
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
|
|
Экспериментальный: GROUP C
3 ml of PRP will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Autologous platelet-rich plasma prepared from preoperatively collected peripheral blood and applied at the bone-tendon interface immediately after repair completion.
|
|
Плацебо Компаратор: GROUP D
3 ml of saline will be placed at the bone-tendon junction immediately after completion of the arthroscopic repair.
|
Standard arthroscopic repair of full-thickness isolated supraspinatus tendon tears using suture anchors.
Three milliliters of sterile normal saline applied at the bone-tendon interface immediately after arthroscopic rotator cuff repair as placebo comparator.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional Outcome Assessed by Constant-Murley Score and ASES Score
Временное ограничение: The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev
|
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively.
Both scores are validated instruments evaluating pain, daily activities, and shoulder function, with higher scores indicating better clinical outcomes.
|
The primary outcome measure will be the functional outcome of the shoulder assessed using the Constant-Murley Score and the American Shoulder and Elbow Surgeons (ASES) score at 3, 6, and 12 months postoperatively. Both scores are validated instruments ev
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rotator Cuff Tendon Integrity Assessed by MRI (Sugaya Classification)
Временное ограничение: 12 months postoperatively
|
Tendon integrity will be evaluated using magnetic resonance imaging (MRI) at 12 months postoperatively.
Repair integrity will be classified according to the Sugaya classification system and categorized to assess healing or re-tear.
|
12 months postoperatively
|
|
Pain Intensity Assessed by Numeric Rating Scale (NRS)
Временное ограничение: 3, 6, and 12 months postoperatively
|
Postoperative pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), at 3, 6, and 12 months postoperatively.
|
3, 6, and 12 months postoperatively
|
|
Health-Related Quality of Life Assessed by SF-12
Временное ограничение: 3, 6, and 12 months postoperatively
|
Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12) at 3, 6, and 12 months postoperatively.
The questionnaire provides physical and mental health composite scores.
|
3, 6, and 12 months postoperatively
|
|
Patient Satisfaction
Временное ограничение: 3, 6, and 12 months postoperatively
|
Patient satisfaction will be assessed using a Numeric Rating Scale from 0 to 10 at 3, 6, and 12 months postoperatively, with higher scores indicating greater satisfaction.
|
3, 6, and 12 months postoperatively
|
|
Postoperative Complications and Retear Rate
Временное ограничение: Up to 12 months postoperatively
|
All postoperative complications and symptomatic retears will be recorded throughout the follow-up period.
|
Up to 12 months postoperatively
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Andriani Zafeiri
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12518/03.02.2026
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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