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Acute Acromioclavicular Dislocation: Epidemiology, Natural History and Analysis of Prognostic Factors

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ClinicalTrials.gov Identifier: NCT03727178
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kristine Bramsen Andersen, Hvidovre University Hospital

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 collar'n 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.


Condition or disease
Acromioclavicular Joint Dislocation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Acromioclavicular Dislocation: Epidemiology, Natural History and Analysis of Prognostic Factors
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations




Primary Outcome Measures :
  1. Western Ontario Shoulder Instability score (WOSI) in percentage [ Time Frame: 3 months ]
    The WOSI score is a Patient Reported Outcome Measure (PROM) evaluating disease-specific quality of life patients with shoulder instability, but can also be used for evaluation of other injuries to the shoulder girdle. In the questionnaire the patients answer 21 questions according to 4 different domains: physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored 1-100 points by marking on a visual analog scale (VAS), and the summation of all the questions results in a final WOSI score, ranging from 0-2100, where 0 is the best score with no influence on quality of life and 2100 is the worst score with the patient experiencing extreme distress in shoulder-related quality of life. The score is often transferred into a %-score, where 100% is best and 0% is worst. The minimal clinically important difference is reported to be 14%. The score will be used as a measurement to determine how well the patients are doing throughout the follow-up period.


Secondary Outcome Measures :
  1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    SPADI is a measurement (a PROM) designed to evaluate patient-reported pain and shoulder disability. For each question, the patient marks his answer on a 0-10 numerical rating scale, where 0 is "no pain" or "no disability" and 10 is "worst pain" or "maximal disability". The total score is expressed as percentage, 0-100%, where a lower score equals a better result. The minimal clinically important difference is 8%.

  2. Western Ontario Shoulder Instability score (WOSI) in percentage [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ]
    The WOSI score is a Patient Reported Outcome Measure (PROM) evaluating disease-specific quality of life patients with shoulder instability, but can also be used for evaluation of other injuries to the shoulder girdle. In the questionnaire the patients answer 21 questions according to 4 different domains: physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored 1-100 points by marking on a visual analog scale (VAS), and the summation of all the questions results in a final WOSI score, ranging from 0-2100, where 0 is the best score with no influence on quality of life and 2100 is the worst score with the patient experiencing extreme distress in shoulder-related quality of life. The score is often transferred into a %-score, where 100% is best and 0% is worst. The minimal clinically important difference is reported to be 14%. The score will be used as a measurement to determine how well the patients are doing throughout the follow-up period.

  3. The patient's satisfaction with the cosmetic result [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    On a scale from 0 to 10, where 0 is very dissatisfied and 10 is very satisfied

  4. Return to work: Number of days passed from the day of the injury to the day where the patient resume his work. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    Number of days passed from the day of the injury to the day where the patient resume his work.

  5. Return to sports: Number of days passed from the day of the injury to the day where the patient resume his sports. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    Number of days passed from the day of the injury to the day where the patient resume his sports.

  6. Range of motion: Bilateral active flexion, measured in degrees. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    Bilateral active flexion of the shoulders, measured in degrees.

  7. Range of motion: Bilateral active abduction, measured in degrees. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    Bilateral active abduction of the shoulders, measured in degrees.


Other Outcome Measures:
  1. Scapula dyskinesis [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    Scapula dyskinesia is defined as abnormal movement, asymmetry or "winging" of the shoulder blade with the patient performing 5x bilateral shoulder flexion followed by 5x bilateral shoulder abduction. If scapula dyskinesia is present in any of the movements, the test is considered positive.

  2. Antero-posterior instability [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    With one hand, the examiner fixates the acromion, while the stability of the joint is tested in the horizontal plane by moving the distal tip of the clavicle antero-posteriorly. The test is positive if there is more movement on the affected side

  3. Superior-inferior instability [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    The stability of the joint in the vertical plane is tested by pressing the protruding lateral tip of the clavicle up and down. The non-affected side is used as a control

  4. O'Briens test [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ]
    With the patient standing or sitting, the shoulder is placed in a 90° flexed and 10-15° horizontally adducted position. In this position, and with the arm stretched, the patient fully internally rotates the shoulder causing the little finger to point upwards. The examiner then applies a distal stabilizing force as the patient is instructed to apply an upward force, causing stress to the AC-joint. The patient will then be asked to perform the same procedure, but with the thump pointing upwards. The test is considered positive if any part of the test results in pain or clicking in the shoulder.

  5. The coraco-clavicular distance expressed in percentage compared to the non-affected side [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    Bilateral Zanca provides the best possible visualization of the AC-joint. The coraco-clavicular distance will be measured and expressed in percentage compared to the non-affected side.

  6. Positive Basamani: overriding of the distal tip of the clavicle to acromion [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    The Basamani (cross body adduction) view is obtained with the patients' arm in a cross-over position. This will stress the acromioclavicular joint and reveal a potential overriding of the clavicle to acromion - which might be significant for an unstable joint.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 patients with acute acromioclavicular dislocation, admitted to the Emergency departments at Hvidovre, Glostrup and Amager Hospitals (Copenhagen). All patients will be treated according the standard regimen.
Criteria

Inclusion Criteria:

  1. Trauma to the shoulder and pain from the AC joint within the last 7 days.
  2. X-ray from the Emergency Room revealing >50% superior displacement of the lateral tip of the clavicle to acromion.
  3. Age 18-60 years
  4. The patient must be expected to be able to attend rehabilitation and post- examinations.
  5. The patient must be able to speak and understand Danish
  6. Signed informed consent.

Exclusion Criteria:

  1. History of previous AC joint dislocation or shoulder trauma (ipsi/contralateral)
  2. Fracture to the upper extremity at time of injury.
  3. Associated injuries to the upper extremity causing limitation of function, including fracture or dislocation of the shoulder

3) Terminal illness or severe medical illness. ASA (American Society of Anesthesiologists) group ≥ 3


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727178


Contacts
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Contact: Kristine B Andersen, MD +45 24651972 bramsen.kristine@gmail.com

Locations
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Denmark
Copenhagen University Hospital Hvidovre Recruiting
Copenhagen, Denmark
Contact: Kristine B Andersen, MD    +4524651972    kristine.bramsen.andersen@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Kristine B Andersen, MD Copenhagen University Hospital, Hvidovre

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Responsible Party: Kristine Bramsen Andersen, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03727178     History of Changes
Other Study ID Numbers: AC_lux_cohort
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristine Bramsen Andersen, Hvidovre University Hospital:
Acromioclavicular Joint Dislocation
AC joint dislocation
Treatment
Conservative treatment
Type III AC dislocation
Grade III AC dislocation
AC joint
Rockwood
Rockwood type III
Rockwood grade III
Additional relevant MeSH terms:
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Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries