Acromioclavicular Joint DislocationNCT03261778
Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations
A study testing Acromion 2.0 Brace in people with Acromioclavicular Joint Dislocation, run by Bürgerspital Solothurn at 2 sites in Switzerland.
Trial summary
In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromioclavicular Joint Dislocation
- What is being tested?
- Acromion 2.0 Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2017to 12 Jan 2021
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First acute acromioclavicular dislocation Rockwood Type III
Who cannot join
- Previous injury to acromioclavicular Joint
- Previous surgery of acromioclavicular Joint
- Known hypersensitivity or allergy to fabric of investigational product
- Pregnancy
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Orthopädische Universitätsklinik Basel
Basel, 4031
Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
Solothurn, 4500
About this study
Official title: Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial
In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.
The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.
- Conditions
- Acromioclavicular Joint Dislocation
- Being tested
- Acromion 2.0 Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acromion 2.0 BraceDevice
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
| Study group | Role | What they receive |
|---|---|---|
| Acromion 2.0 Brace | Experimental | Not described Receives: Device: Acromion 2.0 Brace |
| Mitella Sling | Active comparator | Not described Receives: Device: Acromion 2.0 Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function
Constant-Score
Measured: at 6 weeks
Shoulder function
Constant-Score
Measured: at 12 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Measured: at 1 week
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Measured: at 6 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Measured: at 12 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Measured: at 1 week
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Measured: at 6 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Measured: at 12 weeks
Secondary outcomes (3)
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Measured: at initial presentation
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Measured: at 6 weeks
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bürgerspital Solothurn
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Principal investigator, Michael Finsterwald, Bürgerspital Solothurn
- Investigators
- Näder Helmy, PD, MD, Study chair, Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261778
- Sponsor's protocol ID
- 2017-00670
- Other IDs
- 2017
- Status last verified
- Jan 2021
- First submitted
- 18 Aug 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.
PubMed 9728155Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31.
PubMed 24178060Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.
PubMed 21344264Duffett RW, Duralde XA, Marcus RE. CORR Synthesis: What Is the Most Effective Treatment for Rockwood Type III Acromioclavicular Joint Dislocations? Clin Orthop Relat Res. 2023 May 1;481(5):1008-1013. doi: 10.1097/CORR.0000000000002545. Epub 2023 Jan 13. No abstract available.
PubMed 36728233
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03261778
- Acronym / sponsor ID
- 2017-00670
- Conditions
- Acromioclavicular Joint Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bürgerspital SolothurnUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 25 Aug 2017 (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.
In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.
The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromion 2.0 Brace | Experimental | Device: Acromion 2.0 Brace |
| Mitella Sling | Active comparator | Device: Acromion 2.0 Brace |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First acute acromioclavicular dislocation Rockwood Type III
Key exclusion criteria (6 listed)
- Previous injury to acromioclavicular Joint
- Previous surgery of acromioclavicular Joint
- Known hypersensitivity or allergy to fabric of investigational product
- Pregnancy
- Known or suspected non-compliance, drug or alcohol abuse
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 |
|---|---|---|
| Acromion 2.0 BraceAcromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling | Device | Acromion 2.0 Brace, Mitella Sling |
Primary outcome
Shoulder function
Time frame: at 6 weeks
Constant-Score
Shoulder function
Time frame: at 12 weeks
Constant-Score
Shoulder function
Time frame: at 1 week
ASES-Score (American Shoulder and Elbow Score)
Shoulder function
Time frame: at 6 weeks
ASES-Score (American Shoulder and Elbow Score)
Shoulder function
Time frame: at 12 weeks
ASES-Score (American Shoulder and Elbow Score)
Shoulder function
Time frame: at 1 week
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Shoulder function
Time frame: at 6 weeks
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Shoulder function
Time frame: at 12 weeks
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
3 secondary outcomes
Degree of lateral clavicle dislocation
Time frame: at initial presentation
Degree of lateral clavicle dislocation
Time frame: at 6 weeks
Degree of lateral clavicle dislocation
Time frame: at 12 weeks
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 13 Jan 2021.
- Background: PubMed 9728155Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.
- Background: PubMed 24178060Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31.
- Background: PubMed 21344264Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.
- Derived from this study: PubMed 36728233Duffett RW, Duralde XA, Marcus RE. CORR Synthesis: What Is the Most Effective Treatment for Rockwood Type III Acromioclavicular Joint Dislocations? Clin Orthop Relat Res. 2023 May 1;481(5):1008-1013. doi: 10.1097/CORR.0000000000002545. Epub 2023 Jan 13. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Näder Helmy, PD, MD study chair
Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acromion 2.0 Brace in people with Acromioclavicular Joint Dislocation, run by Bürgerspital Solothurn at 2 sites in Switzerland.
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 1 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: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Shoulder function (time frame: at 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261778, which also lists 4 linked publications.
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 13 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.