Acromioclavicular Joint DislocationNCT02195219
Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations
A study testing open reduction internal fixation and sling rest and early functional recovery in people with Acromioclavicular Joint Dislocation, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- What is being tested?
- open reduction internal fixation and sling rest and early functional recovery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Dec 2017
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years.
- Grade III acromioclavicular dislocation.
- Signed informed consent.
Who cannot join
- Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease…).
- Previous acromioclavicular osteoarthritis.
- Previous acromioclavicular lesions.
- Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.
- Polytraumatized patients.
- Any disease or condition the investigator finds decisive for exclusion.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon
Madrid, 28007
About this study
Official title: Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations
The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment.
For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.
Read the detailed description
Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries.
There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6.
For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them.
During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient.
The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.
- Conditions
- Acromioclavicular Joint Dislocation
- Being tested
- open reduction internal fixation, sling rest and early functional recovery
- Keywords
- conservative, treatment, surgical, Acromioclavicular, Joint, dislocation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction internal fixationProcedure or surgery
MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.
sling rest and early functional recoveryOther
Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.
| Study group | Role | What they receive |
|---|---|---|
| open reduction internal fixation | Experimental | open reduction internal fixation Receives: Procedure: open reduction internal fixation |
| non operative treatment | Active comparator | 'sling rest and early functional recovery Receives: Other: sling rest and early functional recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.
Measured: 12 months
Secondary outcomes (1)
X-ray evaluation
X-ray evaluation of the patients who underwent open reduction and internal fixation treatment, comparing the results with the contralateral shoulder and with the preoperative images:
- Width of the acromioclavicular joint in millimetres, before and after surgery.
- Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery.
- Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Unable reach recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular Joint DislocationStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Alvarez, Hospital General Universitario Gregorio Marañon
- Investigators
- Mikel Aburto, MD, Principal investigator, Hospital Heneral Universitario Gregorio Maranon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195219
- Sponsor's protocol ID
- ACLUX-3
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2014
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations
- ClinicalTrials.gov ID
- NCT02195219
- Acronym / sponsor ID
- ACLUX-3
- Conditions
- Acromioclavicular Joint Dislocation
- Keywords
- conservative, treatment, surgical, Acromioclavicular, Joint, dislocation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable reach recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Jul 2014 (estimated)
- 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.
The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment.
For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.
Detailed description
Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries.
There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6.
For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them.
During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient.
The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open reduction internal fixation | Experimental | Procedure: open reduction internal fixationopen reduction internal fixation |
| non operative treatment | Active comparator | Other: sling rest and early functional recovery'sling rest and early functional recovery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 50 years.
- Grade III acromioclavicular dislocation.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease…).
- Previous acromioclavicular osteoarthritis.
- Previous acromioclavicular lesions.
- Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.
- Polytraumatized patients.
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 |
|---|---|---|
| open reduction internal fixationMINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out. | Procedure or surgery | open reduction internal fixation |
| sling rest and early functional recoveryImmobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed. | Other | non operative treatment |
Primary outcome
Efficacy
Time frame: 12 months
Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.
1 secondary outcome
X-ray evaluation
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
Related trials for Acromioclavicular Joint Dislocation
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Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries
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Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
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Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction
Acromioclavicular; Dislocation, Ligament Repair or Reconstruction
Not yet recruiting
Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconstruction With AC Ligament Reconstruction vs. CC Ligaments Reconstruction With AC Temporary k Wire Fixation
Acromioclavicular Joint, Acromioclavicular Joint Dislocation
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.
Mikel Aburto, MD principal investigator
Hospital Heneral Universitario Gregorio Maranon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction internal fixation and sling rest and early functional recovery in people with Acromioclavicular Joint Dislocation, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Mar 2018. 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 Spain. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy (time frame: 12 months). 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 16 Mar 2018.