HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial (HORAC)

December 1, 2023 updated by: Miha Ambrožič, University Medical Centre Ljubljana

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

Comparing different treatement strategies in augmenting clavicle stabilisation

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: non-absorbable tape fixation around AC joint
fixation around AC joint with tape in different configurations
Procedure: coracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
Sham Comparator: 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.
Procedure: coracoclavicular (CC) fixation
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
Procedure: no fixation around AC joint
there will be no additional fixation around AC joint in this group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MAmbrozic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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