Dynamic Changes of Functional Outcome and Generic Quality of Life After Arthroscopic Rotator Cuff Repair: a Longitudinal Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
研究概览
简要总结
The goal of this longitudinal study is to understand the postoperative quality of life and dynamic trajectory of shoulder function in individuals with rotator cuff tears.
详细描述
Rotator cuff tears (RCTs) involve rupture of shoulder tendons or muscles, leading to pain and weakness. Its prevalence increases with age and is influenced by factors such as handedness, obesity, and smoking. Although conservative treatments are common, surgery aims to restore function. However, limited research has been conducted on postoperative psychological and social changes. Patient-reported outcome (PRO) and health-related quality of life (HRQOL) assessments are gaining importance, offering comprehensive insights into patient experiences.
This longitudinal study will include 200 randomized controlled trials (RCTs) of patients who undergo surgery. Demographics, physical examinations, and scales, such as ASES, WORC, WHOQOL-BREF, and EQ-5D, are collected preoperatively and at 2 weeks and 3, 6, 9, and 12 months postoperatively. MRI is used to assess postoperative healing at 6 months. Statistical analyses are performed using SAS software encompassing chi-square, t-tests, linear mixed effects models, and subgroup analyses to identify determinants of postoperative quality of life and functionality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were evaluated by orthopedic surgeons as having a rotator cuff tear between August 2021 and July 2022, confirmed by magnetic resonance imaging (MRI) or ultrasound. If the patients required surgery and were willing to participate in the trial, the research assistant provided informed consent.
排除标准
- •Acromioclavicular arthritis requiring distal clavicular resection.
- •Severe glenohumeral arthritis (Hamada classification grade 3 or higher).
- •History of shoulder fracture.
- •Absolute contraindications to MRI, such as claustrophobia, pacemakers, neurostimulators, drug infusion pumps, artificial inner ear implants, and metallic implants.
研究组 & 干预措施
Patients with rotator cuff tears pending for arthroscopic rotator cuff repair
This is a Longitudinal Study. Patients were evaluated by orthopedic surgeons as having a rotator cuff tear, confirmed by magnetic resonance imaging (MRI) or ultrasound. If the patients required surgery and were willing to participate in the trial, the research assistant provided informed consent. The exclusion criteria were as follows.
- Acromioclavicular arthritis requiring distal clavicular resection.
- Severe glenohumeral arthritis (Hamada classification grade 3 or higher)15.
- History of shoulder fracture.
- Absolute contraindications to MRI, such as claustrophobia, pacemakers, neurostimulators, drug infusion pumps, artificial inner ear implants, and metallic implants.
干预措施: Arthroscopic rotator cuff repair (Procedure)
结局指标
主要结局
Shoulder joint angles and strength were tracked preoperatively and at 3, 6, 9, and 12 months postoperatively.
时间窗: 1 year
1. Patients were seated comfortably, and a goniometer was used to measure the active range of motion (ROM) of shoulder joint angles, including internal rotation, external rotation, abduction, extension, and flexion. 2. Patients were seated comfortably and a manual hydraulic push-pull dynamometer was used to measure the strength of internal rotation, external rotation, abduction, extension, and flexion.
次要结局
- American Shoulder and Elbow Surgeons Score (ASES Score)(1 year)
- Questionnaire Survey(1 year)
- Western Ontario Rotator Cuff Index(WORC)(1 year)
- Taiwan Version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) Questionnaire(1 year)
- EQ-5D Quality of Life Questionnaire for Preoperative Utility Assessment(1 year)