Lok™ Suture Anchors Safety & Performance Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair.
- Кому может быть актуально
- Состояния в реестре: Rotator Cuff Tears of the Shoulder, Labrum Injury. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial
Обзор
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed. The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
Вмешательства
- Процедура Rotator cuff lesions repair combined to a long head of biceps pathology
Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion), - Процедура PASTA lesion
partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair - Процедура Shoulder instability repair
Gleno-humeral instabilities (Bankart lesion, SLAP lesion)
Первичные конечные точки
- Constant score [Срок оценки: From enrollment to the final follow up at 12 months]
Вторичные конечные точки (3)
- Visual Analog Scale (VAS) [Срок оценки: From enrollment to the end of follow up at 12 months]
- Adverse Events (AEs) [Срок оценки: from enrollment to the final follow up at 12 months]
- Subjective Shoulder Value (SSV) [Срок оценки: From enrollment to the final follow up at 12 months]
Критерии участия
Критерии включения
- Consent to participate in the study: oral and written.
- Man or woman over 18 years old with bone maturity finished.
- Presented with one of the following indications:
- Rotator cuff lesion (tear or calcific tendinopathy) associated to a pathology of the long head of the biceps,
- Gleno-humeral instability,
- partial articular-sided tendon avulsion \[PASTA\] lesion.
- MRI or arthrogram proving the rotator cuff lesion and long head of the biceps tendon injury, or the labrum injury, or PASTA injury.
Non inclusion Criteria:
- Radiographic sign of fracture: glenoid or lesser tuberosity.
- Major trauma to the shoulder joint.
- Any active infection or avascular necrosis.
- Inflammatory joint disease.
- Moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4).
- Bone pathologies compromising anchorage (cystic changes, severe osteopenia).
- Pathological conditions of soft tissues impairing suture fixation.
- Known hypersensitivity to implant material (PEEK and carbon or Polyethylene).
- Anterior ipsilateral surgeries performed on the joint space.
- Physical conditions that would eliminate, or tend to eliminate, adequate anchoring support or delay healing.
- Contraindications from the instructions for use of the medical devices used.
- Conditions that would limit the subject's ability or willingness to restrict activities or follow instructions during the healing period.
- Inability to complete questionnaires: language problems, who do not speak/read/understand French.
- Pregnant or breastfeeding women.
- Persons deprived of liberty or under guardianship.
- Patients unable to undergo medical monitoring of the trial.
- Psychiatric illnesses, cognitive disorders, or health problems that prevent informed consent.
- Participation in another clinical trial.
- Life expectancy of less than 12 months.
- No health insurance.
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
Франция · 1 центр
- Alixan — Valence
Идентификаторы
NCT: NCT07448584 · lok01