Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations (AC Cons Chir)

April 11, 2019 updated by: Adrien Schwitzguebel, La Tour Hospital

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

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

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adrien Schwitzguébel, MD, La Tour Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • GE 15-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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