Acute Acromioclavicular Dislocation: Epidemiology, Natural History and Analysis of Prognostic Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Western Ontario Shoulder Instability score (WOSI) in percentage
研究概览
简要总结
Aim:
To evaluate non-operative treatment of acute acromioclavicular (AC) joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm.
Objectives:
- To investigate whether a sub classification of Rockwoods type III in a stable type IIIA and an unstable type IIIB, as suggested by ISAKOS (International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine), is clinically relevant. Clinically relevant is defined as a difference in the WOSI score of >14%
- To evaluate clinical, functional and radiological results, along with patient-reported health, 6 weeks, 3 months, 6 months and 1 year after acute AC dislocation
- To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
- To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury.
Type of study: Prospective cohort study. 100 patients will be included.
Time schedule:
Recruitment of patients is planned to begin November 2018. It is expected that the inclusion will span 1 year, provided an average of 2 patients included per week. With a 1-year follow-up for each patient the total study period is expected to be 2 years.
Set-up:
In the Capital Region of Denmark the majority of patients with acute AC joint dislocation are treated non-operatively. A collar'n cuff is applied in the emergency room and the patient is instructed to begin non-weight bearing exercises after 1-3 weeks.
100 patients with acute AC-joint dislocation will be included in the cohort and evaluated at controls 6 weeks, 3 months, 6 months and 1 year after the injury. The patients will be identified from X-rays obtained in the Emergency Departments at three Danish Hospitals.
At each control the patient will reply to 2 questionnaires regarding their shoulder-related function and quality of life, be evaluated through 5 clinical tests, and 2 different X-rays of the AC-joint will be obtained.
详细描述
Introduction:
Acromioclavicular (AC) joint dislocations are common injuries accounting for 9-12% of all injuries to the shoulder girdle. The injuries are graded according to Rockwoods classification type I-VI. There is consensus on the treatment of Rockwood type I and II which rehabilitates well with conservative treatment, and for high-grade injuries of types IV, V and VI, which usually requires surgery. However the treatment of the most common type, type III, has remained controversial for the last 30 years. To assess this problem, ISAKOS (International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine) Upper Extremity Committee in 2014 provided a modified Rockwood classification, suggesting a sub-classification of the debated type III in a stable type IIIA and an unstable type IIIB.
The purpose of this sub-classification is to identify and differentiate patients, who are expected to rehabilitate well with conservative treatment from those who would benefit from early surgical intervention, i.e. type IIIA and IIIB. Type IIIA is considered stable and is characterized by absence of scapula dyskinesia and no overriding of the clavicle to acromion. Type IIIB is characterized by presence of scapula dyskinesia and no overriding of the clavicle to acromion.
Aim:
To evaluate non-operative treatment of acute acromioclavicular (AC) joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma to the shoulder and pain from the AC joint within the last 7 days.
- •X-ray from the Emergency Room revealing >50% superior displacement of the lateral tip of the clavicle to acromion.
- •Age 18-60 years
- •The patient must be expected to be able to attend rehabilitation and post- examinations.
- •The patient must be able to speak and understand Danish
- •Signed informed consent.
排除标准
- •History of previous AC joint dislocation or shoulder trauma (ipsi/contralateral)
- •Fracture to the upper extremity at time of injury.
- •Associated injuries to the upper extremity causing limitation of function, including fracture or dislocation of the shoulder
- •Terminal illness or severe medical illness. ASA (American Society of Anesthesiologists) group ≥ 3
结局指标
主要结局
Western Ontario Shoulder Instability score (WOSI) in percentage
时间窗: 3 months
The WOSI score is a Patient Reported Outcome Measure (PROM) evaluating disease-specific quality of life patients with shoulder instability, but can also be used for evaluation of other injuries to the shoulder girdle. In the questionnaire the patients answer 21 questions according to 4 different domains: physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored 1-100 points by marking on a visual analog scale (VAS), and the summation of all the questions results in a final WOSI score, ranging from 0-2100, where 0 is the best score with no influence on quality of life and 2100 is the worst score with the patient experiencing extreme distress in shoulder-related quality of life. The score is often transferred into a %-score, where 100% is best and 0% is worst. The minimal clinically important difference is reported to be 14%. The score will be used as a measurement to determine how well the patients are doing throughout the follow-up period.
次要结局
- Shoulder Pain and Disability Index (SPADI)(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Western Ontario Shoulder Instability score (WOSI) in percentage(Baseline, 6 weeks, 6 months, 1 year)
- The patient's satisfaction with the cosmetic result(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Return to work: Number of days passed from the day of the injury to the day where the patient resume his work.(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Return to sports: Number of days passed from the day of the injury to the day where the patient resume his sports.(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Range of motion: Bilateral active flexion, measured in degrees.(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Range of motion: Bilateral active abduction, measured in degrees.(Baseline, 6 weeks, 3 months, 6 months, 1 year)
研究者
Kristine Bramsen Andersen
Medical Doctor
Hvidovre University Hospital