HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

N/AUnknownNCT05143853

University Medical Centre Ljubljana70 enrolled

Overview

Comparing different treatement strategies in augmenting clavicle stabilisation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acromioclavicular Separation

Interventions

non-absorbable tape fixation around AC jointPROCEDURE

fixation around AC joint with tape in different configurations

no fixation around AC jointPROCEDURE

there will be no additional fixation around AC joint in this group

coracoclavicular (CC) fixationPROCEDURE

mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Constant-Murley score, minimum score 1, maximum score 100 (higher = better)

patient-reported outcome measure (PROM)

Time frame: 1 year

Secondary Outcomes

SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)

PROM

Time frame: 1 year

Horizontal RTG measurements, measured in mm

Overlap length (OL)

Time frame: 1 year

Horizontal RTG measurements, measured in mm2

Overlap area (OA)

Time frame: 1 year

Data from ClinicalTrials.gov

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