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).
ID
Bron
Verkorte titel
Aandoening
Patients requiring total shoulder replacement
Ondersteuning
Leiden University Medical Center
Department of Orthopaedics, head of department prof. R.G.H.H. Nelissen
Project leader: prof. P.M. Rozing
PO Box 9600
2300 RC Leiden
The Netherlands
tel.: +31-(0)71-5262581
fax: +31-(0)71-5266743
e-mail: f.steenbrink@lumc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Component fixation (Rontgen Stereophotographic Analysis (RSA)) <br>
2. Shoulderfunctioning (Range of Motion (RoM), Questionnaires for shoulder functioning)<br>
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksproduct en/of interventie
Total shoulder replacement
Publiek
Laboratory for Movement Analysis
P.O. Box 9600
F. Steenbrink
Leiden 2300 RC
The Netherlands
+31(0)71 5262581
f.steenbrink@lumc.nl
Wetenschappelijk
Laboratory for Movement Analysis
P.O. Box 9600
F. Steenbrink
Leiden 2300 RC
The Netherlands
+31(0)71 5262581
f.steenbrink@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL803 |
NTR-old | NTR816 |
Ander register | : p06.017 |
ISRCTN | ISRCTN42881741 |