Acromioclavicular Joint DislocationNCT01725997
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation
A study testing hook plate and Physiotherapy in people with Acromioclavicular Joint Dislocation, run by St Goran's Hospital at 1 site in Sweden.
Trial summary
The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- What is being tested?
- hook plate and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSweden
- Study dates
- 14 Nov 2012to 5 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
- men and women 18-65 years and able to work
- understand spoken and/or written Swedish or English language
- be able to start treatment within 3 weeks from trauma
- consent form signed
Who cannot join
- earlier injury to, or surgery of either of the shoulders
- simultaneous fracture of the clavicle or acromion
- associates neurovascular injury
- severe osteoporosis
- open dislocation
- open growth plate of the acromion
- local skin damage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study
The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.
- Conditions
- Acromioclavicular Joint Dislocation
- Being tested
- hook plate, Physiotherapy
- Keywords
- acromioclavicular joint dislocation, ac joint dislocation, acromioclavicular joint separation, hook plate, Rockwood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hook plateProcedure or surgery
Also called hook plate by Synthes
Surgery with hook plate followed by physiotherapy
PhysiotherapyOther
Patients will be following a program specific for AC joint dislocations
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Active comparator | Operative treatment with hook plate. Receives: Procedure: hook plate |
| Conservative treatment | Active comparator | Physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Score
Measured: change from Baseline in Constant Score at 24 months
Secondary outcomes (1)
Disabilities of Arm, Shoulder and Hand function (QuickDASH)
Measured: change from Baseline in QuickDASH at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study start14 Nov 2012
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Goran's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Boström Windhamre, St Goran's Hospital
- Investigators
- Helena Boström Windhamre, Principal investigator, St Goran's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725997
- Sponsor's protocol ID
- AC-lux
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2012
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01725997
- Acronym / sponsor ID
- AC-lux
- Conditions
- Acromioclavicular Joint Dislocation
- Keywords
- acromioclavicular joint dislocation, ac joint dislocation, acromioclavicular joint separation, hook plate, Rockwood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- St Goran's HospitalUniversity, hospital or other
- Study start
- 14 Nov 2012 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 14 Nov 2012 (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 study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Active comparator | Procedure: hook plateOperative treatment with hook plate. |
| Conservative treatment | Active comparator | Other: PhysiotherapyPhysiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
- men and women 18-65 years and able to work
- understand spoken and/or written Swedish or English language
- be able to start treatment within 3 weeks from trauma
- consent form signed
Key exclusion criteria (7 listed)
- earlier injury to, or surgery of either of the shoulders
- simultaneous fracture of the clavicle or acromion
- associates neurovascular injury
- severe osteoporosis
- open dislocation
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 |
|---|---|---|
| hook plateAlso: hook plate by SynthesSurgery with hook plate followed by physiotherapy | Procedure or surgery | Operative treatment |
| PhysiotherapyPatients will be following a program specific for AC joint dislocations | Other | Conservative treatment |
Primary outcome
Constant Score
Time frame: change from Baseline in Constant Score at 24 months
1 secondary outcome
Disabilities of Arm, Shoulder and Hand function (QuickDASH)
Time frame: change from Baseline in QuickDASH at 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
Related trials for Acromioclavicular Joint Dislocation
Recruiting
Contralateral Resistance Training During Immobilization in Patients With Acromioclavicular Joint Injury
Acromioclavicular Joint Injury, Acromioclavicular Joint Dislocation
Enrolling by invitation
Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries
AC Joint Dislocation
RecruitingObservational study
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
Acromioclavicular; Dislocation
Active, not recruitingObservational study
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.
Helena Boström Windhamre principal investigator
St Goran's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hook plate and Physiotherapy in people with Acromioclavicular Joint Dislocation, run by St Goran's Hospital at 1 site in Sweden.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jan 2020. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Score (time frame: change from Baseline in Constant Score at 24 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 28 Jan 2020.