Cost-Effectiveness of Rotator Cuff Repair Surgery by Open and Arthroscopic Techniques. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Constant-Murley Score (CM)
研究概览
简要总结
Shoulder pain is one of the most common musculoskeletal complaints in orthopedic practice. Rotator cuff injuries account for up to 70% of pain in the shoulder girdle. There is no clinical study carried out in Brazil comparing cost effectiveness between the open and arthroscopic methods of rotator cuff repair surgery.
The present study aims to determine which method of repair of the rotator cuff, open or arthroscopic, has the best cost effectiveness ratio.
A randomized clinical trial will be carried out in which patients with symptomatic rotator cuff lesion will be submitted to repair surgery by either open or arthroscopic technique and will be subsequently evaluated.
详细描述
Introduction:
Musculoskeletal injuries are a major cost to the healthcare system. In 2004, 30% of the North American population had some kind of musculoskeletal disorder that required medical treatment; between 2002 and 2004, the estimated cost of treating these changes was $ 510 billion. Shoulder diseases represent the third most common cause of these changes, behind only spinal and knee disorders.
An evaluation of the primary health care system in Cambridge, United Kingdom, showed that the average frequency of shoulder pain was 9.5 per 1,000 individuals. Of these, 86% had rotator cuff tendinopathy. North American data estimate that approximately 4.5 million patients annually seek medical attention due to shoulder pain; of these, two million have some symptoms related to the rotator cuff. About 250,000 rotator cuff repair surgeries are performed annually in the United States of America (US), and with the continued increase in life expectancy and aging, there is a tendency to increase this number.
The rotator cuff is composed of the tendons of the subscapularis, supraspinatus, infraspinatus and teres minor muscles. The long portion of the biceps tendon also contributes to cuff function, which is to stabilize the humeral head in the glenoid cavity, preventing superior migration of the humeral head.
The possible lesions range from tendon degeneration (tendinosis/tendinopathy), through partial lesions (articular, interstitial or bursal), to complete lesions. Diagnosis is made by associating history and physical examination along with imaging methods, and magnetic resonance imaging (MRI) is considered the method of choice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Outcome evaluators will be masked (blinded) and not involved with the study. The statisticians who will conduct the analyzes will also be masked to the treatment status until the analyzes are completed. Due to the types of interventions, it will not be possible to mask the participants and providers of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complete rotator cuff injury, symptomatic, where there was failure or the patient could not support the non-surgical treatment;
- •Patients with high-grade partial rotator cuff injury where therapy failed or the patient did not support non-surgical treatment;
- •Patients without medical contraindications for surgery;
- •Patients with a good understanding of the Portuguese language and who agree to participate and sign the Informed Consent Form.
排除标准
- •Patients under 18 years old
- •Patients with previous shoulder surgery;
- •Patients with limited range of motion of the shoulder (joint stiffness);
- •Patients with previous fractures in the affected shoulder;
- •Patients with signs of glenohumeral osteoarthritis;
- •Patients with neurological injury;
- •Patients who opt not to participate and/or are not willing to sign the informed consent form;
- •Patients unable to complete the follow-up evaluation (inability to read or complete the forms).
结局指标
主要结局
Constant-Murley Score (CM)
时间窗: Measured continuously for 48 weeks after the intervention
The Constant-Murley Score (CM) validated for the Portuguese language. The evaluators will ask the patients to fill in the validated CM form for the Portuguese language and measure the range of motion with a goniometer. The CM scale covers different domains of shoulder function (pain, activities of daily living, range of motion and power), punctuating each of them; it ranges from 0 to 100, with higher scores indicating better function.
EuroQol-5D-3L (European Quality of Life)
时间窗: Measured continuously for 48 weeks after the intervention
EuroQol-5D-3L (European Quality of Life), a generic score developed to describe health-related quality of life will also be assessed preoperatively, at 6, 24 and 48 weeks postoperatively. This score includes five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each domain has 3 levels: no problem; some problems and extreme problems. In addition, the EuroQol-5D-3L has a visual analog scale where the participant assigns a value between zero and one hundred to his or her own health condition. At the end of its application, EuroQol-5D-3L will provide a unique numerical value that can be used for longitudinal comparison between two time periods (pre and postoperative, for example).
次要结局
- Simple Shoulder Test (SST)(Measured continuously for 48 weeks after the intervention)
- Visual Analogue Pain Scale (VAS)(Measured continuously for 48 weeks after the intervention)