HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Acromioclavicular Separation
• Interventions: Procedure: non-absorbable tape fixation around AC joint; Procedure: no fixation around AC joint; Procedure: coracoclavicular (CC) fixation

• 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

Arm && Interventions

Group	Intervention	Description
group with tape augmentation of acromioclavicular (AC) joint	non-absorbable tape fixation around AC joint	patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
group without tape augmentation of AC joint	no fixation around AC joint	patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
group with tape augmentation of acromioclavicular (AC) joint	coracoclavicular (CC) fixation	patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
group without tape augmentation of AC joint	coracoclavicular (CC) fixation	patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.

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