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Biomechanics Clavicle Study.


- candidate number10600
- NTR NumberNTR3167
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-nov-2011
- Secondary IDsP11.101 METC LUMC
- Public TitleBiomechanics Clavicle Study.
- Scientific TitleA biomechanical study on functional outcome after a midshaft clavicular fracture with a 3D-Electromagnetic Motion Tracking Device.
- ACRONYMBMCS
- hypothesisFrom the literature it i likely that shortening of the clavicule >15mm leads to impairment of the shoulder function (especially regarding abduction). This association has not been scientifically proven, howeer, partially due to the fact that methods for a precise measurement of functional impairment of the shoulder are lacking. In this pilot study we want to study whether a new technique, 3D-Electromagnetic Motion Tracking Device (Flock of Birds), can provide more insight into this association. We assume that at most 10% of the patients with clavicular shortening <15 mm experience impairment in abduction. On anatomical grounds we expect that this percentage is at least 50% in the patients with a clavicular shortening> 15 mm.
- Healt Condition(s) or Problem(s) studiedClavicula, Functional outcome, 3D-Electromagnetic Motion Tracking Device, Shortening
- Inclusion criteria1. A (dislocated) midshaft clavicular fracture 1 or 5 years ago;
2. Age when fracture occured above 18 and below 60 years;
3. Clavicular shortening of respectively, <10mm, 10-20mm and >20 mm.
- Exclusion criteria1. Current or previous fracture in the proximal or distal third of the clavicule, or acromio-clavicular injury;
2. Prior surgery to the shoulder or prior shoulder complaints before fracture;
3. Neurovascular injury with objective neurological findings after fracture or developed due to other illnesses;
4. Pathologic fracture;
5. New fractures of ipsilateral or contralateral shoulders/arm that could influence the active Range of Motion.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 14-nov-2011
- planned closingdate1-aug-2012
- Target number of participants32
- InterventionsN/A
- Primary outcomeTo assess the influence of clavicular shortening after fracture consolidatin of a midshaft clavicular fracture, on the Active Range of Motion of the shoulder, with help of a 3D-Electromagnetic Motion Tracking Device (Flock of Birds) after one and five years post-fracture.
- Secondary outcomeThe secondary objective will be to compare the clavicular length as measured on a conventional X-ray as usual care and estimated with the 3D-Electromagnetic Motion Tracking Device on the basis of the bony landmarks. Furthermore,force measurements of both arms will be accomplished with use of MicroFETs, a handheld dynamometer. Each participants is asked to fill out a questionnaire related to the function of arm, shoulder and Hand (Disabilities of Arm, Shoulder and Hand-Outcome Measure (DASH)).
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.A. Stegeman
- CONTACT for SCIENTIFIC QUERIES S.A. Stegeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-nov-2011 - 12-dec-2011


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