HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

Acromioclavicular Separation Clinical Trial

— HORAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05143853
• Other study ID #: MAmbrozic
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing different treatement strategies in augmenting clavicle stabilisation

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromioclavicular Separation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant-Murley score, minimum score 1, maximum score 100 (higher = better)	patient-reported outcome measure (PROM)	1 year
Secondary	SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)	PROM	1 year
Secondary	Horizontal RTG measurements, measured in mm	Overlap length (OL)	1 year
Secondary	Horizontal RTG measurements, measured in mm2	Overlap area (OA)	1 year