Comparison of Coracoclavicular Fixation With Versus Without Acromioclavicular Stabilization for Repair of Acute Acromioclavicular Joint Dislocations: A Randomized Controlled Clinical Trial, Double-blind Test
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- User satisfaction rate
研究概览
简要总结
The entire upper extremity is attached to the axial skeleton, specifically through the clavicle and the acromioclavicular articulation (AC). The stability of the AC articulation is provided by coracoclavicular ligaments in the vertical plane and acromioclavicular ligaments in the horizontal plane. The AC luxation is a frequent pathology in youth and athletes that practice contact sports, it has incidence 9,2 per 1000 inhabitants per year, which represents between 30% to 50% of shoulder injuries in young athletes, which is more frequent in men than in women with a ratio of 8:1. Its main injury mechanism is direct trauma while the shoulder is adducted and its less frequent secondary indirect mechanism following is of a fall of the extended arm. In 1984 the Rockwood team published the most used and accepted classification system till this day, which is divided into 6 types according to the grade of instability types. The treatment is usually conservative in patients with Rockwood type I and II lesions and surgical in types IV, V and VI. There is controversy in the surgical indication of type III lesions, highlighting the importance of medial stability associated with the characteristics and expectations of each patient. Although there are more than 160 described surgical techniques, the percentage of complications is considerable, with a 14% of intra-operative complications, 21% reduction loss and a 10% end up in a revision surgery .
To minimize the complications and obtain better functional results, the idea of this randomized controlled clinical trial was born.
详细描述
THEORETICAL FRAME The upper extremity is completely attached by the axial skeleton, especially through the clavicle and the acromioclavicular articulation (AC)(1). The previously mentioned articulation is a diarthrodial joint. The stability of this articulation is caused by coracoclavicular ligaments in the vertical plane and the acromioclavicular ligaments in the horizontal plane(2). The AC luxation is a common pathology in youth and athletes who participate in contact sports which has a 9,2 per 1000 incidence between inhabitants every year represented between 30% to 50% from shoulder injuries in young athlete, it is most common in men than women with a ratio of 8:1(3). It's main injury mechanism is direct trauma while the shoulder is adducted and less frequently is the indirect mechanism of dropping the arm in an extended motion(4). In the year 1963, Tossy et al(5) for the first time described and classified some of the patterns of luxation AC, which was then extended to 6 AC luxation degrees and published by Rockwood in the year 1984 becoming the first most accepted and used till this day(6). There have many techniques of conservative treatment and surgery management as a treatment for all time of laxation AC (Rockwood grades I-VI) written as time passed by, although literature suggests and supports the conservative treatment for grades I and II and the surgical management for grades IV-V-VI, the optimal treatment for grade III injuries is still controversial(7). In regards to these type of injuries, taking into account the importance of medial stability an agreement was taken by the committee of the upper extremity of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS), which suggests that a subdivision of the III grade of Rockwood in IIIA when the AC articulation is stable and the IIIB when the AC articulation is unstable(8), helping to differentiate and identify the patients with grade III Rockwood in a better manner who will be benefited from a surgical treatment.
To evaluate the correct AC luxation ligaments, the radiological evaluation must include a projection of bilateral, axillary Zanca and Alexander (also known as Basmania). This last projection has increased its relevance in the past couple of years since it can help us to differentiate whether there's a presence or an absence of medial instability in the case of Rockwood III AC luxation(9). Till this day there are no actual standardized measurements that guide the correct manner of treating it with a good variability, Zumstein et al(10) proposed 2 new quantitative parameters to evaluate the vertical and horizontal instability and based on the Alexander view. To evaluate the vertical stability the use of the vertical distance between the center of the acromion and the midpoint of the lateral clavicle (AC-DC) and to evaluate the horizontal stability he used the distance of the center of the glenoid and lateral clavicle (GC-PC). Both parameters were shown to be trusted sources with excellent validity, which helped guide the treatment for some AC luxation, especially for Rockwood grade II and III injuries.
Despite the numerous described surgical techniques, currently more than 160, do not show evidence of superiority of one in specific and there is no agreement whether it is necessary to stabilize only the AC articulation in the vertical, horizontal or both planes(11). In this case more attention is focused on the complex AC ligament standing out the superior AC band as its main horizontal stabilizer(12), which does have an injury and in the process of insufficiently healing and repairing it can contribute up to 50% of horizontal instability in the AC articulation(13). Many studies demonstrate that the horizontal instability can have an important clinical relevance associated with the worst functional postsurgical results(14-16) which during the past couple of years has increased the interest of conducting many surgical techniques to better the horizontal stability and so the functional results after surgery(17). Al though there have been many advances in surgical techniques during the time, the percentage of complications are still considerable, with up to 14% of inoperable complications, 21% reduction loss and 10% remains in revision surgery(4). With the result of minimizing complications and obtaining better functional results arises the idea of conducting the randomized clinical trial.
INVESTIGATION QUESTIONING
"In patients with an acute and unstable acromioclavicular luxation, the coracoclavicular fixation with stabilized acromioclavicular has a clinical impact to decrease of complications and better its functionality?"
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)
入排标准
- 年龄范围
- 15 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rockwood IIIB, V, and VI acromioclavicular luxation
- •Less than 14 días of progression time since the lesion
- •Patient over the age of 15
- •Possibility of clinical monitoring
- •Informed and validated consent by the ethics committee
排除标准
- •Surgery previously done on the clavicle and/or ipsilateral acromioclavicular, contralateral and/or bilateral articulation.
- •Neuropathy of motor or mixed upper extremities.
- •Exposure of an acromioclavicular injury.
- •Fractures associated with clavicles, scapula and/or ipsilateral humerus.
- •Function alterations concerning the previously mentioned extremity.
- •Functional alterations of the contralateral extremity.
- •Disease that can evolve with neuropathy during the study period (Multiple Sclerosis, Vasculitis, badly controlled Diabetes with progressed damage, etc.)
结局指标
主要结局
User satisfaction rate
时间窗: Up to 12 month
The clinical impact of the daily strength, proprioception, range of movement and decrease of pain (functional Score: ASES Score, CONSTANT Score, Nottingham clavicle score)
Complication rates
时间窗: Up to 12 month
Number of participants with fail of the implant, loss of the reduction, clavicular or coracoid fracture, pain associated with the implant and infections
次要结局
- Rate of coracoclavicular reduction(Up to 12 month)
- Number of participants who ned of postoperative analgesic(Up to 12 month)
- Number of participants who returned to normal adduction force after surgery(Up to 12 month)
- Rate of revision surgery(Up to 12 month)
研究者
Martin Zecher Magni
Orthopedic surgeon
Universidad de La Frontera
