HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial
NCT ID: NCT05143853
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2021-04-23
2024-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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group with tape augmentation of acromioclavicular (AC) joint
patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.
non-absorbable tape fixation around AC joint
fixation around AC joint with tape in different configurations
coracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
group without tape augmentation of 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.
no fixation around AC joint
there will be no additional fixation around AC joint in this group
coracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
Interventions
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non-absorbable tape fixation around AC joint
fixation around AC joint with tape in different configurations
no fixation around AC joint
there will be no additional fixation around AC joint in this group
coracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
Eligibility Criteria
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Inclusion Criteria
* OP in 3 weeks after injury
* patient age between 16 and 65 years
* normal shoulder function before injury
Exclusion Criteria
* ipsilateral arm/shoulder girdle/hand injuries
* very low patient's physical demands
* previous injuries of the affected area
* Rockwood classification 1, 2, or 6
16 Years
65 Years
ALL
Yes
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Miha Ambrožič
Principal Investigator
Locations
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University Medical Center Ljubljana
Ljubljana, , Slovenia
Countries
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Other Identifiers
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MAmbrozic
Identifier Type: -
Identifier Source: org_study_id