A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH).
研究概览
简要总结
The purpose of this study is to compare non-operative treatment versus operative treatment in patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study will show if one method is superior to the other and will also show advantages and disadvantages associated with each treatment method.
详细描述
All patients presenting to the hospital with a Type III, IV or V acute acromioclavicular (AC) joint dislocation and meeting the eligibility criteria will be approached and asked to enter this prospective, randomized clinical trial. After obtaining consent, the subject will be managed in accordance with one of the two randomized treatment strategies. The first treatment strategy will involve conservative (nonoperative) management of the AC joint dislocation. The second treatment strategy will involve operative fixation (i.e. ORIF) of the dislocation with a hook plate and screws.
The subjects in both treatment groups will receive post-operative care according to the same standards and protocol. The surgeon and research staff will be responsible for study follow-up (clinical and radiological assessment) of the patient on admission (baseline), on discharge from the hospital and at post-operative intervals of six weeks, three months, six months, one year and two years. Primary and secondary outcomes will be monitored at these post-operative intervals.
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
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 16 to 65 years of age
- •Grade III (3), IV (4) or V (5) dislocation of the acromioclavicular (AC) joint (evidenced by no contact between the distal clavicle and the acromion as seen in standardized radiographs)
- •Closed injury
- •AC joint dislocations within 28 days post injury
- •Provision of informed consent
排除标准
- •Grade I(1), II (2), or VI (6) subluxation/dislocation of the AC joint
- •Open AC joint separation
- •Scapulothoracic dissociation
- •Presence of vascular injury
- •Dislocations over 28 days post-injury
- •Limited life expectancy due to significant medical co-morbidity
- •Medical contraindication to surgery (including pregnancy)
- •Inability to comply with rehabilitation or form completion
- •Inability to provide informed consent
- •Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e., patients with no fixed address, patients not mentally competent to give consent, etc.)
研究组 & 干预措施
1
Conservative (nonoperative) management of the AC joint dislocation.
干预措施: Non operative treatment of AC joint dislocation (sling) (Other)
2
Operative fixation (i.e., ORIF) of the dislocation with a hook plate and screws.
干预措施: Open Reduction Internal Fixation of AC joint dislocation (Procedure)
结局指标
主要结局
The primary outcome measure will be a patient-oriented, limb-specific, functional measurement questionnaire score (Disabilities of the Arm, Shoulder and Hand - DASH).
时间窗: 2 years
2 years for recruitment plus 2 years for follow-up. Total study duration = 4 years
次要结局
- Secondary measures will include radiographic (anatomical reduction and arthritic changes 20) and clinical assessment outcomes.(2 years)