Acromioclavicular Separation
Conditions
Brief summary
Comparing different treatement strategies in augmenting clavicle stabilisation
Interventions
PROCEDUREnon-absorbable tape fixation around AC joint
fixation around AC joint with tape in different configurations
PROCEDUREno fixation around AC joint
there will be no additional fixation around AC joint in this group
PROCEDUREcoracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley score, minimum score 1, maximum score 100 (higher = better) | 1 year | patient-reported outcome measure (PROM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Horizontal RTG measurements, measured in mm2 | 1 year | Overlap area (OA) |
Countries
Slovenia
Outcome results
None listed