Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02677441
Status:
UNKNOWN
Last Update Posted:
2019-04-12
First Post:
2016-02-02
Brief Title:
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations
Sponsor:
La Tour Hospital
Organization:
La Tour Hospital
Study Overview
Official Title:
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations A Non-inferiority Randomized Study
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AC Cons Chir
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 ie comparison of ipsilateral and contralateral coracoclavicular distance on anterior view and dynamic posterior shaft of the cross-body adduction BasamaniaAlexander 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
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 ie comparison of ipsilateral and contralateral coracoclavicular distance on anterior view and dynamic posterior shaft of the cross-body adduction BasamaniaAlexander 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 conservativelyIt 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 11 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 -1645 with a non-inferiority margin of 64 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 64 ASES standard deviation after surgical management of ACJD has been estimated to 97 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 -64 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 8050110 176 patients
ACJD can be either managed conservatively or surgically Concerning functional outcomes it usually accepted that ACJD Rockwood state I and II should be treated conservativelyIt 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 11 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 -1645 with a non-inferiority margin of 64 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 64 ASES standard deviation after surgical management of ACJD has been estimated to 97 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 -64 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 8050110 176 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None