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Biomechanical Reposition techniques in Anterior Shoulder Dislocation.

Biomechanische repositie technieken van een schouder ontwrichting



- candidate number24178
- NTR NumberNTR5839
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2016
- Secondary IDsNL54173.094.15 M015-028 METC
- Public TitleBiomechanical Reposition techniques in Anterior Shoulder Dislocation.

Biomechanische repositie technieken van een schouder ontwrichting
- Scientific TitleBiomechanical Reposition techniques in Anterior Shoulder Dislocation. A randomised controlled multicenter clinical trial.

Biomechanische repositietechnieken in anterior schouderontwrichting. Een gerandomiseerd, multicenter klinische onderzoek
- ACRONYMBRASD-trial
- hypothesisTo establish which BRT or combination of BRTs is the fastest, least painful and has the lowest complication rate for adult patients with an anterior shoulder dislocation presenting in the emergency department (ED).
- Healt Condition(s) or Problem(s) studiedShoulder dislocation
- Inclusion criteriaAll adult patients (> 18 years) with an isolated anterior shoulder dislocation
- Exclusion criteria subcapital humeral fractures
multi trauma
subclavicul-, thoracic- , inferior or posterior dislocation
dislocations presented after 24 hours
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-mei-2018
- Target number of participants222
- InterventionsDepending on ability to adduct patients will be randomized for biomechanical repositioning (BRT) according to Cunningham, Modified Milch or Scapular manipulation technique and Modified Milch or Scapula manipulation technique.
- Primary outcomePrimary outcome length of ED stay will be described in minutes and will be analysed using ANOVA analyse in case of normality can be assumed, or Kruskall-Wallis test in case of normality cannot be assumed. Median/average pain on the NRS scale during and after reposition will be also be analysed using ANOVA analyse in case of normality can be assumed, or Kruskall-Wallis test in case of normality cannot be assumed.
- Secondary outcomeSecondary outcome will be procedure time in minutes, percentage of successful reduction, complications, patients satisfaction and analgesia/sedation used, These secondary outcomes will be reported individually and clustered.
- TimepointsNone
- Trial web siteNone
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Roetman
- CONTACT for SCIENTIFIC QUERIESMD D.N. Baden
- Sponsor/Initiator Flevo Hospital
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-apr-2016 - 22-jun-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl