No registrations found.
ID
Source
Brief title
Health condition
Patients requiring total shoulder replacement
Sponsors and support
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
Intervention
Outcome measures
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)
Background 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.
Study objective
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).
Intervention
Total shoulder replacement
Laboratory for Movement Analysis
P.O. Box 9600
F. Steenbrink
Leiden 2300 RC
The Netherlands
+31(0)71 5262581
f.steenbrink@lumc.nl
Laboratory for Movement Analysis
P.O. Box 9600
F. Steenbrink
Leiden 2300 RC
The Netherlands
+31(0)71 5262581
f.steenbrink@lumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL803 |
| NTR-old | NTR816 |
| Other | : p06.017 |
| ISRCTN | ISRCTN42881741 |