跳至主要内容
临床试验/NCT07311616
NCT07311616尚未招募不适用

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

Beijing Jishuitan Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire)

时间窗: At baseline and at 3, 6 and 12 months after the operation.

This outcome measure will be assessed using the American Shoulder and Elbow Surgeons Score (ASES), a disease-specific patient-reported outcome questionnaire. The scale consists of two key dimensions: pain (50 points, measured by Visual Analog Scale) and daily living functions (50 points, evaluating 10 activities including dressing, combing hair, and using the toilet). The total score ranges from 0 to 100, with higher scores indicating better shoulder function and less pain.

次要结局

  • Shoulder Function Measured By Constant-Murley Score(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)(At Basline, 1 day after the operation, and 3, 6, and 12 months after the operation)
  • Range of Motion (ROM)(At baseline and at 3, 6, and 12 months after operation)
  • Rate of Postoperative Complications(At 6 weeks, 3 months, 6 months and 12 months after the operation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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