Acromioclavicular SeparationHORACNCT05143853
HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial
A study testing non-absorbable tape fixation around AC joint, no fixation around AC joint and coracoclavicular (CC) fixation in people with Acromioclavicular Separation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Comparing different treatement strategies in augmenting clavicle stabilisation Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromioclavicular Separation
- What is being tested?
- non-absorbable tape fixation around AC joint, no fixation around AC joint and coracoclavicular (CC) fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSlovenia
- Study dates
- 23 Apr 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Acromioclavicular Separation
- Being tested
- non-absorbable tape fixation around AC joint, no fixation around AC joint, coracoclavicular (CC) fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-absorbable tape fixation around AC jointProcedure or surgery
fixation around AC joint with tape in different configurations
no fixation around AC jointProcedure or surgery
there will be no additional fixation around AC joint in this group
coracoclavicular (CC) fixationProcedure or surgery
mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons
| Study group | Role | What they receive |
|---|---|---|
| group with tape augmentation of acromioclavicular (AC) joint | Active comparator | patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area. Receives: Procedure: non-absorbable tape fixation around AC joint; Procedure: coracoclavicular (CC) fixation |
| group without tape augmentation of AC joint | Sham comparator | patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area. Receives: Procedure: no fixation around AC joint; Procedure: coracoclavicular (CC) fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
patient-reported outcome measure (PROM)
Measured: 1 year
Secondary outcomes (3)
SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)
PROM
Measured: 1 year
Horizontal RTG measurements, measured in mm
Overlap length (OL)
Measured: 1 year
Horizontal RTG measurements, measured in mm2
Overlap area (OA)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start23 Apr 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular SeparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miha Ambrožič, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143853
- Sponsor's protocol ID
- MAmbrozic
- Acronym
- HORAC
- Status last verified
- Dec 2023
- First submitted
- 29 Apr 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Additional Horizontal Fixation After Arthroscopically Assisted Coracoclavicular Stabilisation Matter in Final Outcome Measures: a Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05143853
- Acronym / sponsor ID
- HORAC / MAmbrozic
- Conditions
- Acromioclavicular Separation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing different treatement strategies in augmenting clavicle stabilisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with tape augmentation of acromioclavicular (AC) joint | Active comparator | Procedure: non-absorbable tape fixation around AC joint, Procedure: coracoclavicular (CC) fixationpatients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area. |
| group without tape augmentation of AC joint | Sham comparator | Procedure: no fixation around AC joint, Procedure: coracoclavicular (CC) fixationpatients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-absorbable tape fixation around AC jointfixation around AC joint with tape in different configurations | Procedure or surgery | group with tape augmentation of acromioclavicular (AC) joint |
| no fixation around AC jointthere will be no additional fixation around AC joint in this group | Procedure or surgery | group without tape augmentation of AC joint |
| coracoclavicular (CC) fixationmandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons | Procedure or surgery | group with tape augmentation of acromioclavicular (AC) joint, group without tape augmentation of AC joint |
Primary outcome
Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
Time frame: 1 year
patient-reported outcome measure (PROM)
3 secondary outcomes
SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)
Time frame: 1 year
Horizontal RTG measurements, measured in mm
Time frame: 1 year
Horizontal RTG measurements, measured in mm2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-absorbable tape fixation around AC joint, no fixation around AC joint and coracoclavicular (CC) fixation in people with Acromioclavicular Separation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley score, minimum score 1, maximum score 100 (higher = better) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.