Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations: A Non-inferiority Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
研究概览
简要总结
This study will evaluate the non-inferiority of conservative management for acromioclavicular clavicle disjunction, compared with surgical management. Half of patients will be treated with a specific standardized rehabilitation protocol, and the other half will be treated with coracoclavicular and acromioclavicular fixation, followed by a another specific standardized rehabilitation protocol.
Outcomes:
The primary outcome is the non-inferiority of the conservative management over surgical management of Rockwood III-V Acute acromioclavicular joint dislocation (ACJD) without PICCAT with American Shoulder and Elbow Surgeons (ASES score) at one year. If the non-inferiority is reached, the non-inferiority of the conservative management over surgical the management of Rockwood III-V ACJD with PICCAT using ASES score at one year will be evaluated.
Secondary outcomes were radiological criteria (i.e. comparison of ipsilateral and contralateral coracoclavicular distance on anterior view; and dynamic posterior shaft of the cross-body adduction Basamania/Alexander view) return to sports, work absenteeism, complication rate, cosmetic results, patients satisfaction, Constant score, Single Assesment Numeric Evaluation (SANE) score, Acromioclavicular Joint Instability (ACJI) score, ASES score at others timepoints, and range of motion of the implicated shoulder. Finally, multivariable regression analysis will be performed in order to evaluate the impact of predictors of interest on ASES score at one year.
详细描述
Background and rationale:
ACJD can be either managed conservatively or surgically. Concerning functional outcomes, it usually accepted that ACJD Rockwood state I and II should be treated conservatively.It is still debated whether grade III should be treated surgically or not, and only experts opinion suggest that grade IV and V has better surgical outcome than conservative. The main literature failed to demonstrate the superiority of the surgical management for functional outcomes. Despite this, operative management results in a better cosmetic outcome, but conservative management is associated with a lower duration of sick leave and lesser costs. It has been purposed by a worldwide expert consensus (ISAKOS consensus) that dynamic posterior clavicle impaction into the trapezius muscle (PICCAT) could be a predictive factor of poor functional outcome in case of conservative management.
Hypothesis:
H0: ASES score at one year of follow-up is better with surgical management than with conservative management.
H1: one year ASES score after conservative management is not inferior as after surgical management. H1 will be first tested without PICCAT. If H1 is validated, it will then be tested again including all patients, PICCAT or not.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute (less than 10 days) ACJD , with possibility to perform surgery within 10 days after the trauma
排除标准
- •Rockwood grade I, II, or IV ACJD
- •Significant other trauma of the involved upper member requiring surgery
- •Associated scapula or clavicle fracture
- •Polytrauma inducing significant limitation of rehabilitation process
- •Inability to follow properly conservative management or post-surgery recommendations
- •Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency
- •Known or suspected non-compliance, drug or alcohol abuse
- •Patients incapable of judgement or under tutelage
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Conservative management
Conservative management includes a sling for 10 days, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement.
干预措施: Conservative management (Procedure)
Surgery
Surgical fixation of ACJD with coracoclavicular and acromioclavicular fixation, followed by specific standardized validated rehabilitation that includes range of motion recovery and progressive reinforcement.
干预措施: Surgery (Procedure)
结局指标
主要结局
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
时间窗: one year
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
时间窗: one year
Will be considered as a secondary outcome if Outcome # 1 is not reached
次要结局
- Acromioclavicular ligament integrity(one year)
- The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding Constant score.(3, 6, and 12 months)
- The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.(3, and 6 months)
- Coracoclaviclular ligament integrity(one year)
- Work absenteeism(through study completion, an average of 1 year)
- Complication rate(through study completion, an average of 1 year)
- ACJI score(3, 6, and 12 months)
- pain VAS score(3, 6, and 12 months)
- Coracoclavicular distance(one year)
- cosmetic result(one year)
- Range of motion: elevation of the involved shoulder(3, 6, and 12 months)
- Impact of predictors of interest on ASES score(one year)
- Dynamic posterior shaft of the clavicle(one year)
- Return to sports(through study completion, an average of 1 year)
- patients satisfaction(one year)
- The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding Constant score.(3, 6, and 12 months)
- The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.(3, and 6 months)
- SANE score(3, 6, and 12 months)
- Ranges of motion: lateral rotation of the involved shoulder(3, 6, and 12 months)
- Ranges of motion: medial rotation of the involved shoulder(3, 6, and 12 months)
研究者
Adrien Schwitzguebel
MD
La Tour Hospital