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

NCT03727178 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Acromioclavicular Joint Dislocation

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Kristine B Andersen, MD · Copenhagen University Hospital, Hvidovre

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2021-01-25
Completion
2021-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727178 on ClinicalTrials.gov