Does Additional Horizontal Fixation After Arthroscopically Assisted Coracoclavicular Stabilisation Matter in Final Outcome Measures: a Prospective Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
Study Overview
Brief Summary
Comparing different treatement strategies in augmenting clavicle stabilisation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: non-absorbable tape fixation around AC joint (Procedure)
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.
Intervention: coracoclavicular (CC) fixation (Procedure)
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.
Intervention: no fixation around AC joint (Procedure)
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.
Intervention: coracoclavicular (CC) fixation (Procedure)
Outcomes
Primary Outcomes
Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
Time Frame: 1 year
patient-reported outcome measure (PROM)
Secondary Outcomes
- Horizontal RTG measurements, measured in mm(1 year)
- Horizontal RTG measurements, measured in mm2(1 year)
- SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)(1 year)
Investigators
Miha Ambrožič
Principal Investigator
University Medical Centre Ljubljana