| - candidate number | 2250 |
| - NTR Number | NTR816 |
| - ISRCTN | ISRCTN42881741 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 21-sep-2006 |
| - Secondary IDs | p06.017 |
| - Public Title | Conform and non conform glenoid components in total shoulder replacements. |
| - Scientific Title | Conform and non conform glenoid components in total shoulder replacements. |
| - ACRONYM | N/A |
| - hypothesis | 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). |
| - Healt Condition(s) or Problem(s) studied | Shoulder disorders |
| - Inclusion criteria | Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis. |
| - Exclusion criteria | 1. 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 received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-nov-2006 |
| - planned closingdate | 1-nov-2010 |
| - Target number of participants | 20 |
| - Interventions | Total shoulder replacement |
| - Primary outcome | 1. Component fixation (Rontgen Stereophotographic Analysis (RSA)) 2. Shoulderfunctioning (Range of Motion (RoM), Questionnaires for shoulder functioning) |
| - Secondary outcome | 1. Glenohumeral translation (Fluoroscopy) 2. Pain (VAS) 3. Maximum arm force 4. Shoulder coordination (Principal action) 5. Proprosepsis (mirroring) |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | F. Steenbrink |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 |
| - Publications | N/A |
| - Brief summary | In 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) | |
| - RECORD | 21-sep-2006 - 29-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl