- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677441
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations (AC Cons Chir)
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations: A Non-inferiority Randomized Study
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandre Lädermann, PD
- Phone Number: +41227197555
- Email: secretariat.laedermann@latour.ch
Study Locations
-
-
Geneva
-
Meyrin, Geneva, Switzerland, 1217
- Recruiting
- La Tour Hospital
-
Contact:
- Alexandre Lädermann, MD
- Phone Number: +41227197555
- Email: alexandre.laedermann@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Specific standardized rehabilitation protocol under Cote et al (2010)
|
Active Comparator: 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.
|
Coracoclavicular and acromioclavicular fixation as described ly Lädermann et al (2011), followed by specific standardized rehabilitation protocol under Cote et al (2010).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding ASES score.
Time Frame: one year
|
one year
|
|
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
Time Frame: one year
|
Will be considered as a secondary outcome if Outcome # 1 is not reached
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coracoclavicular distance
Time Frame: one year
|
Will be measured by comparing ipsilateral and controlateral X-ray
|
one year
|
Dynamic posterior shaft of the clavicle
Time Frame: one year
|
Will be measured on the cross-body adduction Basamania/Alexander view
|
one year
|
Coracoclaviclular ligament integrity
Time Frame: one year
|
Will be assessed on MRI, and scaled with grade 1 (tendinopathy), grade 2 (partial tear), and grade 3 (full tear) injury scale
|
one year
|
Acromioclavicular ligament integrity
Time Frame: one year
|
Will be assessed on MRI, and scaled with grade 1 (tendinopathy), grade 2 (partial tear), and grade 3 (full tear) injury scale
|
one year
|
Return to sports
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
Work absenteeism
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
Complication rate
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
cosmetic result
Time Frame: one year
|
will be scaled on a visual analogue scale, from 0 to 10
|
one year
|
patients satisfaction
Time Frame: one year
|
will be scaled on a visual analogue scale, from 0 to 10
|
one year
|
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD without PICCAT, regarding Constant score.
Time Frame: 3, 6, and 12 months
|
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 Constant score.
Time Frame: 3, 6, and 12 months
|
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.
Time Frame: 3, and 6 months
|
3, and 6 months
|
|
The non-inferiority of the conservative management over surgical management of Rockwood III-V ACJD with and without PICCAT, regarding ASES score.
Time Frame: 3, and 6 months
|
3, and 6 months
|
|
SANE score
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
ACJI score
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
pain VAS score
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
Range of motion: elevation of the involved shoulder
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
Ranges of motion: lateral rotation of the involved shoulder
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
Ranges of motion: medial rotation of the involved shoulder
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
Impact of predictors of interest on ASES score
Time Frame: one year
|
Will be performed my multivariable regression analysis
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adrien Schwitzguébel, MD, La Tour Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE 15-235
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