HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial (HORAC)

University Medical Centre Ljubljana

Status: Active, not recruiting

Conditions: Acromioclavicular Separation

Treatments: Procedure: non-absorbable tape fixation around AC joint; Procedure: no fixation around AC joint; Procedure: coracoclavicular (CC) fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05143853

MAmbrozic

Details and patient eligibility

About

Comparing different treatement strategies in augmenting clavicle stabilisation

Enrollment: 70 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

group with tape augmentation of acromioclavicular (AC) joint

Active Comparator group

Description:

patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.

Treatment:

Procedure: non-absorbable tape fixation around AC joint

Procedure: coracoclavicular (CC) fixation

group without tape augmentation of AC joint

Sham Comparator group

Description:

patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.

Treatment:

Procedure: coracoclavicular (CC) fixation

Procedure: no fixation around AC joint