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

NCT03727178 | Completed

• 1 other identifier: AC_lux_cohort
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To investigate whether specific factors are of prognostic value to the result after non-operative management of acute AC dislocation
4. 4.To investigate if Rockwoods classification of AC dislocations is of prognostic value for the rehabilitation after the injury.

Conditions

Acromioclavicular Joint Dislocation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability score (WOSI) in percentage

  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 months

Secondary Outcomes (7)

• Shoulder Pain and Disability Index (SPADI)

  Baseline, 6 weeks, 3 months, 6 months, 1 year

• Western Ontario Shoulder Instability score (WOSI) in percentage

  Baseline, 6 weeks, 6 months, 1 year

• The patient's satisfaction with the cosmetic result

  Baseline, 6 weeks, 3 months, 6 months, 1 year

• Return to work: Number of days passed from the day of the injury to the day where the patient resume his work.

  Baseline, 6 weeks, 3 months, 6 months, 1 year

• Return to sports: Number of days passed from the day of the injury to the day where the patient resume his sports.

  Baseline, 6 weeks, 3 months, 6 months, 1 year

Other Outcomes (6)

• Scapula dyskinesis

  6 weeks, 3 months, 6 months, 1 year

• Antero-posterior instability

  6 weeks, 3 months, 6 months, 1 year

• Superior-inferior instability

  6 weeks, 3 months, 6 months, 1 year

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• History of previous AC joint dislocation or shoulder trauma (ipsi/contralateral)
• Fracture to the upper extremity at time of injury.
• Associated injuries to the upper extremity causing limitation of function, including fracture or dislocation of the shoulder
• \) Terminal illness or severe medical illness. ASA (American Society of Anesthesiologists) group ≥ 3

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Copenhagen, Denmark

Location

Study Officials

• Kristine B Andersen, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: December 15, 2018
• Primary Completion: January 25, 2021
• Study Completion: October 1, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

DK (1)