An interventional study of Acromion 2.0 Brace in Acromioclavicular Joint Dislocation, sponsored by Bürgerspital Solothurn. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Bürgerspital Solothurn · Not applicable, Interventional, and Treatment
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.
98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 60 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Bürgerspital Solothurn is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Acromion 2.0 Brace
Device: Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Shoulder function
Constant-Score
Time frame: at 6 weeks
Shoulder function
Constant-Score
Time frame: at 12 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 1 week
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 6 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 12 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 1 week
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 6 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 12 weeks
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at initial presentation
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at 6 weeks
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at 12 weeks
Plan to share: Undecided
Ran from Sep 2017 to primary completion in Dec 2020, 39 months.
Of 24 interventional studies with no phase under Joint Dislocations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Bürgerspital Solothurn