Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Ultrasonography
研究概览
简要总结
The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.
First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not.
Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction.
Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).
详细描述
High numbers of re-tear after rotator cuff surgery have been shown, though not always influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a contralateral rotator cuff tendon tear is high.
The aim is to study surgically treated rotator cuff injury patients 5 years after repair to evaluate tendon integrity on ultrasonography and answer the question do the findings correlate with functionality and patient satisfaction. It has been shown that people over the age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006). Therefore the study will evaluate the function and the integrity of the rotator cuff in both shoulders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and
- •Subject gives an informed consent and is willing to come for one outpatient visit.
排除标准
- •Patients who underwent rotator cuff repair for traumatic tears are excluded from clinical assessment (stage II).
- •Patients who underwent revision surgery are excluded from clinical assessment (stage II).
结局指标
主要结局
Ultrasonography
时间窗: 5 years after primary repair
Integrity of the rotator cuff tendons
次要结局
- American Shoulder and Elbow Surgeons (ASES) score(5 years after primary repair)
- The Disabilities of the Arm, Shoulder and Hand (DASH)(5 years after primary repair)
- Constant-Murley score (CMS)(5 years after primary repair)