A Study on the Effectiveness of Preventive Extensive Release of the Rotator Interval and Joint Capsule to Reduce Postoperative Stiffness in Arthroscopic Rotator Cuff Repair

Обзор

The incidence of rotator cuff injuries is high, especially among the elderly. With the aging of the population, the number of surgical patients has increased significantly. However, in the early stage after arthroscopic rotator cuff repair, a considerable proportion of patients are troubled by shoulder joint stiffness, which greatly affects the quality of life and satisfaction of patients after the operation. Despite this, there is still a lack of clear evidence-based medical evidence regarding whether preventive extensive shoulder release and joint capsule release during arthroscopic rotator cuff repair can effectively prevent or alleviate postoperative shoulder stiffness. To clarify this clinical issue, this project intends to conduct a single-blind randomized controlled trial (RCT). Before the operation, patients will be randomly divided into two groups under blinding conditions: the experimental group will receive arthroscopic rotator cuff repair surgery along with preventive extensive shoulder joint release and joint capsule release, while the control group will only receive arthroscopic rotator cuff repair surgery. After the operation, the investigators will conduct follow-up visits for 3 months, 6 months and 12 months for the two groups of patients, and perform magnetic resonance imaging (MRI) at the 12th month to assess the healing of the rotator cuff tendons. ASES score, Constant-Murley score, Visual Analogue Scale (VAS) pain score and active range (ROM) assessment were conducted before the operation and at the follow-up at 3 months, 6 months and 12 months after the operation. The occurrence of postoperative complications of the patients was counted at the last follow-up. Through this study, the investigators expect to provide scientific and effective guidance for the prevention of postoperative adhesions of the shoulder joint.

Вмешательства

• Процедура Prophylactic extensive shoulder release and capsular release
  Before rotator cuff repair, extensive release of the rotator cuff space is performed first, as well as comprehensive release of the middle glenohumeral ligament, inferior glenohumeral ligament, coracohumeral ligament, the area around the subscapularis tendon, the subacromial capsule, and the anterior and posterior inferior joint capsules.
• Процедура Arthroscopic rotator cuff repair
  Arthroscopic rotator cuff repair surgery

Первичные конечные точки

• Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire) [Срок оценки: At baseline and at 3, 6 and 12 months after the operation.]

Вторичные конечные точки (4)

• Shoulder Function Measured By Constant-Murley Score [Срок оценки: At baseline and at 3, 6 and 12 months after the operation.]
• Patient-Reported Shoulder Pain Intensity Measured by Visual Analogue Scale (0-10 Scale) [Срок оценки: At Basline, 1 day after the operation, and 3, 6, and 12 months after the operation]
• Range of Motion (ROM) [Срок оценки: At baseline and at 3, 6, and 12 months after operation]
• Rate of Postoperative Complications [Срок оценки: At 6 weeks, 3 months, 6 months and 12 months after the operation.]

Критерии участия

Критерии включения

• Medium to small-sized (tear size <3 cm) full-thickness supraspinatus muscle tears
• There was no shoulder joint stiffness before the operation. The range of motion of the joint was at least 160° for passive forward flexion under ROM anesthesia, 60° for external rotation when abduction was 0°, and equal to or greater than 60° for passive internal rotation at the level of the 10th thoracic vertebra
• About to undergo ARCR
• No history of trauma
• Patient consent to participate

Критерии исключения

• There was a history of previous surgery on the ipsilateral shoulder
• Other injuries or lesions of the ipsilateral shoulder (such as glenohumeral arthritis, combined acromioclavicular joint dislocation, brachial plexus injury, etc.)
• It can not be completely repaired or even repaired during operation
• Have uncontrolled epilepsy or psychological illness
• Patients who were assessed as not suitable for inclusion in the study group

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Jishuitan Hospital — Пекин

Идентификаторы

NCT: NCT07311616 · MR-11-25-079098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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