HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Acromioclavicular Separation

• Registration Number: NCT05143853
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Comparing different treatement strategies in augmenting clavicle stabilisation

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-23
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-11-20
• Study First Posted: 2021-12-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-05-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• consensus indication for surgical treatment of AC syndesmolysis
• OP in 3 weeks after injury
• patient age between 16 and 65 years
• normal shoulder function before injury

Exclusion Criteria

• open injury
• ipsilateral arm/shoulder girdle/hand injuries
• very low patient's physical demands
• previous injuries of the affected area
• Rockwood classification 1, 2, or 6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Constant-Murley score, minimum score 1, maximum score 100 (higher = better)	1 year	patient-reported outcome measure (PROM)

Secondary Outcome Measures

Name	Time	Method
Horizontal RTG measurements, measured in mm2	1 year	Overlap area (OA)
SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)	1 year	PROM
Horizontal RTG measurements, measured in mm	1 year	Overlap length (OL)

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia