Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727178
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2018-10-30
Brief Title:
Acute Acromioclavicular Dislocation Epidemiology Natural History and Analysis of Prognostic Factors
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Acute Acromioclavicular Dislocation Epidemiology Natural History and Analysis of Prognostic Factors
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
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:
None
Brief Summary:
Aim
To evaluate non-operative treatment of acute acromioclavicular AC joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm
Objectives
1 To investigate whether a sub classification of Rockwoods type III in a stable type IIIA and an unstable type IIIB as suggested by ISAKOS International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine is clinically relevant Clinically relevant is defined as a difference in the WOSI score of 14
2 To evaluate clinical functional and radiological results along with patient-reported health 6 weeks 3 months 6 months and 1 year after acute AC dislocation
3 To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
4 To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury
Type of study Prospective cohort study 100 patients will be included
Time schedule
Recruitment of patients is planned to begin November 2018 It is expected that the inclusion will span 1 year provided an average of 2 patients included per week With a 1-year follow-up for each patient the total study period is expected to be 2 years
Set-up
In the Capital Region of Denmark the majority of patients with acute AC joint dislocation are treated non-operatively A collarn cuff is applied in the emergency room and the patient is instructed to begin non-weight bearing exercises after 1-3 weeks
100 patients with acute AC-joint dislocation will be included in the cohort and evaluated at controls 6 weeks 3 months 6 months and 1 year after the injury The patients will be identified from X-rays obtained in the Emergency Departments at three Danish Hospitals
At each control the patient will reply to 2 questionnaires regarding their shoulder-related function and quality of life be evaluated through 5 clinical tests and 2 different X-rays of the AC-joint will be obtained
To evaluate non-operative treatment of acute acromioclavicular AC joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm
Objectives
1 To investigate whether a sub classification of Rockwoods type III in a stable type IIIA and an unstable type IIIB as suggested by ISAKOS International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine is clinically relevant Clinically relevant is defined as a difference in the WOSI score of 14
2 To evaluate clinical functional and radiological results along with patient-reported health 6 weeks 3 months 6 months and 1 year after acute AC dislocation
3 To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
4 To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury
Type of study Prospective cohort study 100 patients will be included
Time schedule
Recruitment of patients is planned to begin November 2018 It is expected that the inclusion will span 1 year provided an average of 2 patients included per week With a 1-year follow-up for each patient the total study period is expected to be 2 years
Set-up
In the Capital Region of Denmark the majority of patients with acute AC joint dislocation are treated non-operatively A collarn cuff is applied in the emergency room and the patient is instructed to begin non-weight bearing exercises after 1-3 weeks
100 patients with acute AC-joint dislocation will be included in the cohort and evaluated at controls 6 weeks 3 months 6 months and 1 year after the injury The patients will be identified from X-rays obtained in the Emergency Departments at three Danish Hospitals
At each control the patient will reply to 2 questionnaires regarding their shoulder-related function and quality of life be evaluated through 5 clinical tests and 2 different X-rays of the AC-joint will be obtained
Detailed Description:
Introduction
Acromioclavicular AC joint dislocations are common injuries accounting for 9-12 of all injuries to the shoulder girdle The injuries are graded according to Rockwoods classification type I-VI There is consensus on the treatment of Rockwood type I and II which rehabilitates well with conservative treatment and for high-grade injuries of types IV V and VI which usually requires surgery However the treatment of the most common type type III has remained controversial for the last 30 years To assess this problem ISAKOS International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine Upper Extremity Committee in 2014 provided a modified Rockwood classification suggesting a sub-classification of the debated type III in a stable type IIIA and an unstable type IIIB
The purpose of this sub-classification is to identify and differentiate patients who are expected to rehabilitate well with conservative treatment from those who would benefit from early surgical intervention ie type IIIA and IIIB Type IIIA is considered stable and is characterized by absence of scapula dyskinesia and no overriding of the clavicle to acromion Type IIIB is characterized by presence of scapula dyskinesia and no overriding of the clavicle to acromion
Aim
To evaluate non-operative treatment of acute acromioclavicular AC joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm
Objectives
1 To investigate whether a sub classification of Rockwoods type III in a stable type IIIA and an unstable type IIIB as suggested by ISAKOS is clinically relevant Clinically relevant is defined as a difference in the WOSI score of 14
2 To evaluate clinical functional and radiological results along with patient-reported health 6 weeks 3 months 6 months and 1 year after acute AC dislocation
3 To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
4 To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury
Study design The study is carried out as a prospective cohort study 100 patients will be included
Time schedule
Recruitment of patients for the study is planned to begin in November 2018 It is expected that the inclusion will span 1 year provided an average of 2 patients included per week With a 1-year follow-up for each patient the total study period is expected to be 2 years
Methods
Recruitment
100 patients with acute AC-joint dislocation from the Emergency Departments at three different hospitals in the Capital Region of Denmark Hvidovre Glostrup and Amager hospitals will be included in the cohort Patients with superior displacement of the clavicle to the acromion are of interest to the study
At the Emergency Departments the patients will receive the standard conservative treatment of collarn cuff for 1-3 weeks
To identify patients all X-rays of the AC-joint and the clavicle obtained at the three hospitals will be evaluated weekly identifying the presence and degree of potential AC dislocations If the patient meet the inclusion criterias he or she will be invited to participate in the cohort
Follow-up
Participants will be offered an appointment in the ambulatory for baseline evaluation Follow-up measurements will be performed at 6 weeks 3 months 6 months and 1 year after the injury The studys primary endpoint is at the 3 month mark
At the follow-ups participants will be evaluated clinically functionally and radiologically Primary outcome measure is the patients self-reported shoulder-related quality of life evaluated using WOSI Western Ontario Shoulder Instability Index As secondary outcomes patients will evaluate their functional limitations and pain with SPADI Shoulder Pain and Disability Index the cosmetic results with NRS Numeric Rating Scale and attend a clinical evaluation regarding range of motion ROM the presence of scapular dyskinesia antero-posteriorsuperior-inferior instability of the clavicle and OBriens test Two radiographs of the AC-joint will be obtained to determine the coraco-clavicular distance as well as the degree of overriding of the clavicle to acromion
It is expected that a number of patients in the cohort due to sustainable pain and non-acceptable disability will be offered surgical treatment This group will be followed exactly like the group of conservatively treated patients The two groups will be compared both according to their demographical data and their outcome
Discontinuation
Each patient can choose to withdraw from the trial at any time A patient may also be withdrawn from the trial at any time based on the investigators discretion
Data Registration
All relevant data is recorded and stored in a specially designed database RedCap The data registration has been approved by the Danish Data Protection Agency and The Ethical committee of the Capital Region of Denmark
Statistics
The cohort will be described descriptively regarding demographic parameters as well as primary and secondary outcomes The change of the outcomes over time will be described using relevant statistics according to the characteristics of the variables and if necessary the normal distribution A regression analysis will be used to evaluate the association between prognostic factors and recovery
Sample size
The sample size is calculated to detect if a clinical relevant difference in WOSI-score exists between a group with stable type IIIA and unstable type IIIB AC dislocations The calculation is based on a clinical relevant difference in WOSI-score of 14 a standard deviation SD of 20 a significance level of 005 and a power of 90 According to this calculation the study demands 88 patients but because of the risk of drop-out 100 patients will be included
Ethical considerations
The project is approved by the National Committee on Health Research Ethics The purpose of the study is to follow the natural history of a common injury where guidelines for the treatment already exist There is no intervention in the study - patients enrolled will receive the standard treatment in the Emergency Departments They will be offered standardized physiotherapy and extra controls which is considered an advantage for the patients as they receive a thorough follow-up and examination of the healing process The disadvantages for the patients are 1 Participation in the study is time-consuming Patients need to attend 4 extra controls each lasting approximately 1h 2 Exposure to radiation At each control 2 x-rays of the shoulder will be obtained However the radiation exposure is very small only 01-03 mSv x-ray equivalent to a few weeks of background radiation It is believed that the potential benefits for both patients in the study and future patients with AC dislocations thorough follow-up and individualized treatment exceed the the potential inconveniences additional follow-up audits and light exposure to radiation
Acromioclavicular AC joint dislocations are common injuries accounting for 9-12 of all injuries to the shoulder girdle The injuries are graded according to Rockwoods classification type I-VI There is consensus on the treatment of Rockwood type I and II which rehabilitates well with conservative treatment and for high-grade injuries of types IV V and VI which usually requires surgery However the treatment of the most common type type III has remained controversial for the last 30 years To assess this problem ISAKOS International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine Upper Extremity Committee in 2014 provided a modified Rockwood classification suggesting a sub-classification of the debated type III in a stable type IIIA and an unstable type IIIB
The purpose of this sub-classification is to identify and differentiate patients who are expected to rehabilitate well with conservative treatment from those who would benefit from early surgical intervention ie type IIIA and IIIB Type IIIA is considered stable and is characterized by absence of scapula dyskinesia and no overriding of the clavicle to acromion Type IIIB is characterized by presence of scapula dyskinesia and no overriding of the clavicle to acromion
Aim
To evaluate non-operative treatment of acute acromioclavicular AC joint dislocation and define prognostic factors to guide the choice of treatment in order to develop an individualized treatment algorithm
Objectives
1 To investigate whether a sub classification of Rockwoods type III in a stable type IIIA and an unstable type IIIB as suggested by ISAKOS is clinically relevant Clinically relevant is defined as a difference in the WOSI score of 14
2 To evaluate clinical functional and radiological results along with patient-reported health 6 weeks 3 months 6 months and 1 year after acute AC dislocation
3 To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
4 To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury
Study design The study is carried out as a prospective cohort study 100 patients will be included
Time schedule
Recruitment of patients for the study is planned to begin in November 2018 It is expected that the inclusion will span 1 year provided an average of 2 patients included per week With a 1-year follow-up for each patient the total study period is expected to be 2 years
Methods
Recruitment
100 patients with acute AC-joint dislocation from the Emergency Departments at three different hospitals in the Capital Region of Denmark Hvidovre Glostrup and Amager hospitals will be included in the cohort Patients with superior displacement of the clavicle to the acromion are of interest to the study
At the Emergency Departments the patients will receive the standard conservative treatment of collarn cuff for 1-3 weeks
To identify patients all X-rays of the AC-joint and the clavicle obtained at the three hospitals will be evaluated weekly identifying the presence and degree of potential AC dislocations If the patient meet the inclusion criterias he or she will be invited to participate in the cohort
Follow-up
Participants will be offered an appointment in the ambulatory for baseline evaluation Follow-up measurements will be performed at 6 weeks 3 months 6 months and 1 year after the injury The studys primary endpoint is at the 3 month mark
At the follow-ups participants will be evaluated clinically functionally and radiologically Primary outcome measure is the patients self-reported shoulder-related quality of life evaluated using WOSI Western Ontario Shoulder Instability Index As secondary outcomes patients will evaluate their functional limitations and pain with SPADI Shoulder Pain and Disability Index the cosmetic results with NRS Numeric Rating Scale and attend a clinical evaluation regarding range of motion ROM the presence of scapular dyskinesia antero-posteriorsuperior-inferior instability of the clavicle and OBriens test Two radiographs of the AC-joint will be obtained to determine the coraco-clavicular distance as well as the degree of overriding of the clavicle to acromion
It is expected that a number of patients in the cohort due to sustainable pain and non-acceptable disability will be offered surgical treatment This group will be followed exactly like the group of conservatively treated patients The two groups will be compared both according to their demographical data and their outcome
Discontinuation
Each patient can choose to withdraw from the trial at any time A patient may also be withdrawn from the trial at any time based on the investigators discretion
Data Registration
All relevant data is recorded and stored in a specially designed database RedCap The data registration has been approved by the Danish Data Protection Agency and The Ethical committee of the Capital Region of Denmark
Statistics
The cohort will be described descriptively regarding demographic parameters as well as primary and secondary outcomes The change of the outcomes over time will be described using relevant statistics according to the characteristics of the variables and if necessary the normal distribution A regression analysis will be used to evaluate the association between prognostic factors and recovery
Sample size
The sample size is calculated to detect if a clinical relevant difference in WOSI-score exists between a group with stable type IIIA and unstable type IIIB AC dislocations The calculation is based on a clinical relevant difference in WOSI-score of 14 a standard deviation SD of 20 a significance level of 005 and a power of 90 According to this calculation the study demands 88 patients but because of the risk of drop-out 100 patients will be included
Ethical considerations
The project is approved by the National Committee on Health Research Ethics The purpose of the study is to follow the natural history of a common injury where guidelines for the treatment already exist There is no intervention in the study - patients enrolled will receive the standard treatment in the Emergency Departments They will be offered standardized physiotherapy and extra controls which is considered an advantage for the patients as they receive a thorough follow-up and examination of the healing process The disadvantages for the patients are 1 Participation in the study is time-consuming Patients need to attend 4 extra controls each lasting approximately 1h 2 Exposure to radiation At each control 2 x-rays of the shoulder will be obtained However the radiation exposure is very small only 01-03 mSv x-ray equivalent to a few weeks of background radiation It is believed that the potential benefits for both patients in the study and future patients with AC dislocations thorough follow-up and individualized treatment exceed the the potential inconveniences additional follow-up audits and light exposure to radiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None