search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Conform and non conform glenoid components in total shoulder replacements.


- candidate number2250
- NTR NumberNTR816
- ISRCTNISRCTN42881741
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR21-sep-2006
- Secondary IDsp06.017 
- Public TitleConform and non conform glenoid components in total shoulder replacements.
- Scientific TitleConform and non conform glenoid components in total shoulder replacements.
- ACRONYMN/A
- hypothesisConform components are beneficial for motion coordination and reducing high rim-loads, while non-conform components are beneficial in reducing high humerus–to–scapula impulses (impact forces).
- Healt Condition(s) or Problem(s) studiedShoulder disorders
- Inclusion criteriaIndividuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis.
- Exclusion criteria1. Rotator cuff tear, pre-operatively diagnosed by means of MRI.
2. Humeral component with a radius of 20 mm.
3. Prior history of shoulder surgery
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-nov-2010
- Target number of participants20
- InterventionsTotal shoulder replacement
- Primary outcome1. Component fixation (Rontgen Stereophotographic Analysis (RSA))
2. Shoulderfunctioning (Range of Motion (RoM), Questionnaires for shoulder functioning)
- Secondary outcome1. Glenohumeral translation (Fluoroscopy)
2. Pain (VAS)
3. Maximum arm force
4. Shoulder coordination (Principal action)
5. Proprosepsis (mirroring)
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES F. Steenbrink
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Groot, de
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Orthopaedics, Laboratory for Movement Analysis
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- PublicationsN/A
- Brief summaryIn this project we will determine the effect of conform and non-conform glenohumeral components in shoulder arthroplasty on glenohumeral fixation and functional outcome. We believe that conform components are beneficial for motion coordination and reducing high rim-loads, while non-conform components are beneficial in reducing high humerus–to–scapula impulses (impact forces). Glenoid fixation will be determined by means of Röntgen Stereophotogrammetry Analysis (RSA). Functional outcome will be determined by means of RoM, VAS, MVC and Constant Scores. Patients’ level of activity will be determined by means of the Shoulder Rating Questionnaire. In order to understand the clinical and functional outcome, fluoroscopy will be applied to determine the humerus-to-scapula contact area (i.e. direction of loading of the glenoid component), EMG will be used to determine the Principal Action of the recorded shoulder muscles (measure for coordination and co-contraction), and a shoulder model will be used to simulate the observed conditions in order to predict the effect on muscle forces and consequently, on the loading of the implant components.
- Main changes (audit trail)
- RECORD21-sep-2006 - 29-dec-2006


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