NCT03727178

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

Completed Last updated 21 December 2022

What this trial tests

trial in Acromioclavicular Joint Dislocation in 100 participants. Completed in 1 October 2021.

Timeline

15 December 2018

Primary endpoint
25 January 2021

1 October 2021

Quick facts

Lead sponsor	Hvidovre University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	15 December 2018
Primary completion	25 January 2021
Estimated completion	1 October 2021
Sites	1 location across Denmark

Conditions studied

• Acromioclavicular Joint Dislocation — all drugs for Acromioclavicular Joint Dislocation →

Sponsor

Hvidovre University Hospital

Who can join

Adults 18 to 60, any sex, with Acromioclavicular Joint Dislocation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.