Clinical trial NCT02677441: Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations
Official title: Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations: A Non-inferiority Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Conservative Versus Surgical Management
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
Collaborators: name: Swiss Shoulder and Elbow Surgeons Expert Group
First posted: 2016-02-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Study design:

This multicentric case-control study is randomized 1:1 between conservative and surgical treatment of ACJD. It is a non-inferiority trial that includes 176 patients that suffers from acute ACJD Rockwood grade III-V. Conservative management will consist of a sling for 10 days followed by a standardized physical therapy program, (Cote et al. 2010) and surgical management will consist of coracoclavicular and acromioclavicular fixation and specific rehabilitation. Clinical follow-up will last one year.

Statistical analysis

Non-inferiority statistical analysis will be performed upon appropriate unilateral 95% confidence interval margin (Z = -1.645), with a non-inferiority margin of 6.4, corresponding to ASES minimal clinically important difference. Analysis is planned in case of "intention to treat" method, but, if patients of the conservative management group undergo surgery because they are unsatisfied, ASES score will be measured prior surgery instead of at one year of follow-up. No statistical adjustments on potential confounders are planned.

Sample size calculation:

ASES score minimal clinically important difference has been estimated to 6.4. ASES standard deviation after surgical management of ACJD has been estimated to 9.7. If there is truly no difference between the surgical and conservative treatments, then 80 patients are required to be 90% sure that the lower limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will be above the non-inferiority limit of -6.4. Mazzoca, one of the main authors of ISAKOS consensus (ISAKOS), has reported operating 50% of Rockwood type III-V ACJD. From this, we can strongly suppose that 50% of Rockwood type III-V ACJD presents PICCAT. Considering a 10% of drop-outs, we therefore need 80/(50%)\*110% = 176 patients.

Eligibility criteria: Inclusion Criteria:

* acute (less than 10 days) ACJD , with possibility to perform surgery within 10 days after the trauma

Exclusion Criteria:

* 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

Primary outcomes:
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
timeFrame: one year
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
timeFrame: one year
Secondary outcomes:
measure: Coracoclavicular distance
timeFrame: one year
measure: Dynamic posterior shaft of the clavicle
timeFrame: one year
measure: Coracoclaviclular ligament integrity
timeFrame: one year
measure: Acromioclavicular ligament integrity
timeFrame: one year
measure: Return to sports
timeFrame: through study completion, an average of 1 year
measure: Work absenteeism
timeFrame: through study completion, an average of 1 year
measure: Complication rate
timeFrame: through study completion, an average of 1 year
measure: cosmetic result
timeFrame: one year
measure: patients satisfaction
timeFrame: one year
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding Constant score.
timeFrame: 3, 6, and 12 months
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding Constant score.
timeFrame: 3, 6, and 12 months
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
timeFrame: 3, and 6 months
measure: The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
timeFrame: 3, and 6 months
measure: SANE score
timeFrame: 3, 6, and 12 months
measure: ACJI score
timeFrame: 3, 6, and 12 months
measure: pain VAS score
timeFrame: 3, 6, and 12 months
measure: Range of motion: elevation of the involved shoulder
timeFrame: 3, 6, and 12 months
measure: Ranges of motion: lateral rotation of the involved shoulder
timeFrame: 3, 6, and 12 months
measure: Ranges of motion: medial rotation of the involved shoulder
timeFrame: 3, 6, and 12 months
measure: Impact of predictors of interest on ASES score
timeFrame: one year
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour Hospital
state: Geneva
Study officials:
affiliation: La Tour Hospital
name: Adrien Schwitzguébel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.
citation: Tamaoki MJ, Belloti JC, Lenza M, Matsumoto MH, Gomes Dos Santos JB, Faloppa F. Surgical versus conservative interventions for treating acromioclavicular dislocation of the shoulder in adults. Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD007429. doi: 10.1002/14651858.CD007429.pub2.
citation: Beitzel K, Mazzocca AD, Bak K, Itoi E, Kibler WB, Mirzayan R, Imhoff AB, Calvo E, Arce G, Shea K; Upper Extremity Committee of ISAKOS. ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries. Arthroscopy. 2014 Feb;30(2):271-8. doi: 10.1016/j.arthro.2013.11.005.
citation: Cote MP, Wojcik KE, Gomlinski G, Mazzocca AD. Rehabilitation of acromioclavicular joint separations: operative and nonoperative considerations. Clin Sports Med. 2010 Apr;29(2):213-28, vii. doi: 10.1016/j.csm.2009.12.002.
citation: Ladermann A, Grosclaude M, Lubbeke A, Christofilopoulos P, Stern R, Rod T, Hoffmeyer P. Acromioclavicular and coracoclavicular cerclage reconstruction for acute acromioclavicular joint dislocations. J Shoulder Elbow Surg. 2011 Apr;20(3):401-8. doi: 10.1016/j.jse.2010.08.007.