HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

Study Overview
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Brief Summary
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Comparing different treatement strategies in augmenting clavicle stabilisation

Official Title
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Does Additional Horizontal Fixation After Arthroscopically Assisted Coracoclavicular Stabilisation Matter in Final Outcome Measures: a Prospective Randomised Clinical Trial

Conditions
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Acromioclavicular Separation

Intervention / Treatment
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* Procedure: non-absorbable tape fixation around AC joint
* Procedure: no fixation around AC joint
* Procedure: coracoclavicular (CC) fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group with tape augmentation of acromioclavicular (AC) joint<br>patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area. | Procedure: non-absorbable tape fixation around AC joint<br>* fixation around AC joint with tape in different configurations<br>Procedure: coracoclavicular (CC) fixation<br>* mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons<br>|
| Sham Comparator: group without tape augmentation of AC joint<br>patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area. | Procedure: no fixation around AC joint<br>* there will be no additional fixation around AC joint in this group<br>Procedure: coracoclavicular (CC) fixation<br>* mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley score, minimum score 1, maximum score 100 (higher = better) | patient-reported outcome measure (PROM) | 1 year | 

Secondary Outcome Measures

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