Acromioclavicular Joint DislocationNCT01274884
Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series
A study testing Tightrope fixation in people with Acromioclavicular Joint Dislocation, run by Sykehuset Asker og Baerum at 1 site in Norway.
Trial summary
Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- What is being tested?
- Tightrope fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute acromioclavicular joint dislocation
- 18 years or older
Who cannot join
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).
Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.
Read the detailed description
The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.
- Conditions
- Acromioclavicular Joint Dislocation
- Being tested
- Tightrope fixation
- Keywords
- Acromioclavicular, Injury, Dislocation, Surgery
- Medical subject headings
- Wounds and Injuries, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tightrope fixationProcedure or surgery
Also called Tightrope (R) (Arthrex, Naples, Florida)
Arthroscopic repair
| Study group | Role | What they receive |
|---|---|---|
| Acromioclavicular joint dislocation | Active comparator | Surgery: Arthroscopic repair using the Tightrope fixation device Receives: Procedure: Tightrope fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
Shoulder outcome score
Measured: 1 Year
Secondary outcomes (3)
Plain radiographs
Measured: 1 Year
VAS Pain
Visual analogue acale 1-10
Measured: 1 Year
VAS Satisfaction
Visual analogue acale 1-10
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 posted12 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2013
- Study completionJul 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Asker og Baerum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wender Figved, Sykehuset Asker og Baerum
- Investigators
- Wender Figved, MD, PhD, Study director, Baerum Hospital, Vestre Viken, NorwayOdd A Lien, MD, Principal investigator, Baerum Hospital, Vestre Viken, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274884
- Sponsor's protocol ID
- ACLUX2010
- Status last verified
- Nov 2014
- First submitted
- 11 Jan 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).
- ClinicalTrials.gov ID
- NCT01274884
- Acronym / sponsor ID
- ACLUX2010
- Conditions
- Acromioclavicular Joint Dislocation
- Keywords
- Acromioclavicular, Injury, Dislocation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sykehuset Asker og BaerumUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jan 2011 (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.
Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.
Detailed description
The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromioclavicular joint dislocation | Active comparator | Procedure: Tightrope fixationSurgery: Arthroscopic repair using the Tightrope fixation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute acromioclavicular joint dislocation
- 18 years or older
Key exclusion criteria (1 listed)
- Unable to sign informed consent
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 |
|---|---|---|
| Tightrope fixationAlso: Tightrope (R) (Arthrex, Naples, Florida)Arthroscopic repair | Procedure or surgery | Acromioclavicular joint dislocation |
Primary outcome
Constant score
Time frame: 1 Year
Shoulder outcome score
3 secondary outcomes
Plain radiographs
Time frame: 1 Year
VAS Pain
Time frame: 1 Year
VAS Satisfaction
Time frame: 1 Year
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 19 Nov 2014.
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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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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.
Wender Figved, MD, PhD study director
Baerum Hospital, Vestre Viken, Norway
Odd A Lien, MD principal investigator
Baerum Hospital, Vestre Viken, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tightrope fixation in people with Acromioclavicular Joint Dislocation, run by Sykehuset Asker og Baerum at 1 site in Norway.
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 2 inclusion and 1 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 19 Nov 2014. 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 Norway. 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: 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 19 Nov 2014.