Comparison of Coracoclavicular Fixation With Versus Without Acromioclavicular Stabilization for Repair of Acute Acromioclavicular Joint Dislocations: A Randomized Controlled Clinical Trial, Double-blind Test
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Sponsor: Universidad de La Frontera

 
 
 
 
 
 
 
 
 
 
 
COMPARISON OF CORACOCLAVICULAR FIXATION WITH VERSUS WITHOUT 
ACROMIOCLAVICULAR STABILIZATION FOR REPAIR OF ACUTE ACROMIOCLAVICULAR 
JOINT DISLOCATIONS: A RANDOMIZED CONTROLLED CLINICAL TRIAL, DOUBLE-BLIND 
TEST. 
11/08/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

COMPARISON OF CORACOCLAVICULAR FIXATION WITH VERSUS WITHOUT 
ACROMIOCLAVICULAR STABILIZATION FOR REPAIR OF ACUTE ACROMIOCLAVICULAR 
JOINT DISLOCATIONS: A RANDOMIZED CONTROLLED CLINICAL TRIAL, DOUBLE-BLIND 
TEST. 
 
Author: Martin Zecher Magni (1). 
 
Coauthors: Enrique Pávez (2); Andrés Sánchez (2); Felipe Gómez (3). 
(1) Traumatologist, Fellow in Shoulder Surgery, Hospital Hernán Henríquez Aravena de 
Temuco.  
(2 Traumatologist, Shoulder Team, Hospital Hernán Henríquez Aravena of Temuco 
(3) Resident Traumatology and Orthopedics (T&O), Universidad de la Frontera. 
 
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?” 
 
OBJECTIVES 
 
General objectives 
 
• To observe the clinical impact of the fixed coracoclavicular with acromioclavicular 
stabilization and compare it with the isolated coracoclavicular stabilization in the 
management of the unstable acromioclavicular luxation. 
 
Specific objectives 
 
• 
Evaluate the functionality levels and postoperative pain of the surgically 
managed acromioclavicular luxation. 
• 
Evaluate the variation of the post-operational radiological parameters 
(coracoclavicular distance) in the surgical management of the luxation of 
acromioclavicular ligaments. 

• 
Evaluate the incidence of postoperative complications in surgical management 
of luxated acromioclavicular joints. 
 
METHOD 
 
The unstable acromioclavicular luxation evaluated and diagnosed patients will be admitted 
by on duty Traumatologists at the urgency services of Hospital Dr. Hernán Henríquez 
Aravena de Temuco. The unstable acromioclavicular luxation that are surgically managed 
according to the instability criteria found in international literature (Rockwood IIIb, IV, V 
and VI). 
 
The length of the study will be of at least 1 year with the option of continuing it for 2 years. 
The coracoclavicular fixation with and without acromioclavicular stabilization will be 
compared making up two investigation groups. 
 
The patients that fulfill the requirements and criteria for inclusion will be invited to form 
part of the study where they will need to evaluate and sign an informed consent form. 
 
It will be randomized by block using a computer system. The documents will be printed and 
into sealed envelopes. Before the surgery one of the envelopes will be chosen, this envelope 
will contain one of the 2 techniques from which the surgeon will use in the procedure. 
Postoperative evaluations will be done, the patients will be controlled by a surgeon from a 
different team, which will not know the surgical protocol. The first control will be done at 3 
weeks postoperative, then on the 3, 6, 12, and 24 months. During the controls the clinical 
functionality will be evaluated with 3 scores (ASES, Nottingham and Constant) and the 
eventual clinical or radiological complications using an x-ray with Bilateral Zanca view. 
Lastly, the need of analgesia will be consulted, and the presence of complications will be 
evaluated.  
 
Statistically there will be 0.05 alpha used and there will be protocol analysis, as well as, by 
intent to treat for calculation of RR, RRR, RAR, NNT, NNH. Finally, there will be analysis  done 
by subgroups of ages 15-40 and 40-65 years, sex, and acromioclavicular luxation grade 
according to Rockwood, affected side and preoperative evolution time. Lastly, the need of 
analgesia will be consulted, and the presence of complications will be evaluated.  
 
ELECTION OF DESIGN 
 
Our question is about therapy, from which is the best kind that will give us an estimate to 
the truth is through a randomized clinical trial so that we decrease biases. The 2 surgical 
techniques are currently valid alternatives, and they are done in the Hospital Dr. Hernán 
Henríquez Aravena on a routinary basis, so there are no ethical dilemmas in regard to added 
adverse events. 
 
 

 
 
INCLUSION CRITERIA 
 
• 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 
 
EXCLUSION CRITERIA 
 
• 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.) 
 
PRIMARY OUTCOME 
 
• The clinical impact of the daily strength, proprioception, range of movement and 
decrease of pain (functional Score) 
• Complication rates (fail of the implant, loss of the reduction, clavicular or coracoid 
fracture, pain associated with the implant, infections, etc.) 
 
SECONDARY OUTCOME 
 
• Evolution of adduction force according to the postoperative period. 
• Evolution of mobility rate according to the postoperative period. 
• Results of the radiological variable according to the postoperative evolution time. 
• Need of postoperative analgesic.  
• Revision surgery rate according to the postoperative evolution. 
• Presence of side effects. 
 
SURGICAL TECHNIQUE  
 
The procedure will be done with combined anesthesia, using general and locoregional 
anesthesia  with an interscalene block. The patient will be placed in supine position on top 
of an orthopedic bed and an interscapular cushion. Using the gel pads, all of the bone 

prominences are protected. The head needs to be reassured that it is in a secure and correct 
position. The arm that will not be intervened must remain in a neutral position while the 
other is prepared to be sterile manner and positioned along with the adducted body. Finally, 
it is covered with standard sterile drapes. 
Once the patient is in the correct position, the relevant bone prominences of the shoulder 
are palpated and identified (clavicle, acromion, and the coracoid process) and the initial 
incision is marked using a surgical pen, starting on the Langer lines to create a more 
aesthetic scar. With a number 15 scalpel we create an incision in the bretel “continue the 
line of the strap of the brassiere” and we continue to dissect the subcutaneous tissue in the 
same direction until exposing the deltotrapezial fascia, which is opened using Metzenbaum 
scissors parallel to the clavicle, achieving a flap that when it’s raised towards the inside we 
are able to see the upper and lower clavicle and coracoid process. As we palpitate we can 
identify the subcoracoid space and using a subcoracoid suture passer we pass a guiding 
suture maintaining it with mosquito forceps. With a surgical ruler over the top face of the 
clavicle we mark a 1 cm of the most lateral part of the clavicle to do the first tunnel with a 
2,5mm drill from the top to the bottom, then we stabilize a 3-hole third plate with 3 holes 
and a screw in the previously done hole. Continuing with the subcoracoid of 1 Fiberwire 
double number 2 and a thread of Fibertape using a guide suture. Both of the remaining 
holes of the 3-hole third plate are drilled in the direction of the coracoclavicular ligaments 
so that the double Fiberwire and the thread of Fibertape with Nitinol can pass through in a 
retrograde manner. Using the Fiberwire we do a knot  over the 3-hole third plate, then using 
fluoroscopy we visualize the adequate coracoclavicular reduction continuing to tie the 
Fibertape with a knot. It’s important not to cut the remaining suture so that it is set aside 
for the next step. Guided by fluoroscopy, we made an 8mm incision in the lateral edge of 
the acromion, to perform an anterior and posterior clavicular tunnel using an anterior 
cruciate ligament guidewire. Using the first tunnel that goes through the Polyglactin stitch, 
fetching back the thread from the previous one, we go back in the same retrograde manner 
using the Fiberwire threads and the Fibertape that were previously mentioned. Finally, both 
the remaining Fiberwire and Fibertape are tied using a surgical knot achieving AC fixation. 
 
 
POSTOPERATION 
 
After the surgical stabilization on the AC articulation, we indicate that the immobilization of 
the shoulder with a sling for 2 weeks, which is the moment where the patients will be able 
to begin to move passively under shoulder level with the assistance by physical therapist. 
Strengthening is allowed once the patient can fully complete the movement, which is 
generally around the 6th to 8th week. Generally, we allow the patient to retake sports 4 to 6 
months after surgery. 
 
 
RISK OF ADVERSE EVENTS 
There are no additional adverse risks in any surgery of this kind. As mentioned previously, 
the 2 accepted techniques are accepted and utilized by our service currently, therefore, 

there will be no action that will increase the risk of the surgery in comparison to a common 
surgical procedure.  
 
There are no studies that show variations in regard to the pain response of the treatment 
between the two procedures, but there should not be any differences in that aspect. Either 
way, every case will be monitored regarding the response of the analgesia, and it will be 
adjusted according to the patients’ necessities.  
The irradiation from the x-ray taken of the extremities is equivalent to 0.001 mSv of 
effective radiation (19). Since the x-ray control used in this procedure will be normal, there 
will only be 4 x-rays taken, without exceptions, which results in an insignificant additional 
increase in the risk of patient developing cancer due to the test. 
 
In any case, the complications will be detected in an early manner during the evaluations 
done by the investigation team, where these will be handled and monitored, and additional 
controls will be done if necessary.  
 
CONSCENT PROCESS 
 
The responsible investigator and their collaborators are in charge of receiving the consent 
form given by the patient. This will be solicited in a private premises where the patient and 
their family members will be informed about the nature of the investigation, taking the  
necessary time to answer all questions. 
 
The patient will be able to take the document of consent and after its signature, later a copy 
of the document will be provided. If the patient needs to further analyze the document with 
more detail or in case that they do not want to participate they are free to take a copy to 
inspect and analyze.  
 
The patient may withdraw from the study whenever they wish.  
 
RESPONSIBLE OF RECEPTION OF CONSCENT FORM 
(Hospital Hernán Henríquez Aravena) 
• 
Dr. Felipe Gómez Lagos 
• 
Dr. Martin Zecher Magni 
• 
Dr. Andrés Sánchez Garcia  
• 
Dr. Enrique Pávez Uribe 
 
 
FINANCING SOURCING 
 
The study does not count with any sponsors, the financing is run by the investigation team. 
 
CONFLICTS OF INTERESTS 
 

The authors declare that there are no conflicts related to any type of economic interests.  
 
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