Surgical vs. Conservative Treatment: Comparative Analysis of Clinical Outcome for Rockwood Type V AC-Joint Dislocation – a multi-center prospective randomized trial

Not Applicable

Conditions: S43.1
Dislocation of acromioclavicular joint

Registration Number: DRKS00032343

Lead Sponsor: Herz-Jesu-Krankenhaus Münster GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 70

Inclusion Criteria

All men and women aged 18 to 65 who are diagnosed with a type 5 Rockwood AC joint dislocation during the study period will be included in the study. Sufficient compliance to participate in this study as well as the existence of the signed study consent form after oral and written explanation is a prerequisite.

Exclusion Criteria

Exclusion criteria are pre-existing diseases that affect mobility or strength in the affected shoulder joint, previous operations on the affected shoulder, the implementation of immunosuppressive therapy, a lack of patient consent, insufficient compliance, or legal incompetence.
A change from one group to another due to the patient's will does not result in exclusion from the study. The same applies if the patients do not agree to the randomization. The patients will still be clinically monitored and listed as a separate group in the study design (the drop-out group).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ACJI-Score (Acromioclavicular Joint Instability Score)<br><br>Timetable:<br>Measured at fixed intervals: (2 weeks (conservative group only), 6 weeks, 6 months, and 12 months post-surgery/trauma)

Secondary Outcome Measures

Name	Time	Method
Clinical Endpoints:<br>• Range of Motion (ROM) of the shoulder joint<br>• Patient satisfaction (scale from 0 to 10 (0 = very dissatisfied, 10 = maximum<br>satisfaction)),<br>• Pain level (scale from 0 to 10 (0 = no pain, 10 = worst pain))<br>• Need for analgesics<br>• Return-to-sports<br>• Return-to-work<br><br>Objective Scores:<br>• Constant Score<br>• Taft Score<br>• ASES Score (American Shoulder and Elbow Surgeons score)<br>• SACS (Specific AC Score)<br>• SSV (Subjective Shoulder Value)<br>• SICK Scapula Score (Scapular Dyskinesia)<br><br>Radiological Difference:<br>• Difference between the affected side in AC + CC distance compared to the opposite side in % (X-ray/Sonography)<br><br><br>Timetable:<br>Measured at fixed intervals: (2 weeks (conservative group only), 6 weeks, 6 months, and 12 months post-surgery/trauma)