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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR816
Date of registration: 21/09/2006
Primary sponsor: Leiden University Medical Center (LUMC), Department of Orthopaedics, Laboratory for Movement Analysis
Public title: Conform and non conform glenoid components in total shoulder replacements.
Scientific title: Conform and non conform glenoid components in total shoulder replacements. - N/A
Date of first enrolment: 1/11/2006
Target sample size: 20
Recruitment status: recruiting
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=816
Study type:  intervention
Study design:  Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: -  
Countries of recruitment
The Netherlands
Contacts
Name: F.  Steenbrink
Address:  Leiden University Medical Center (LUMC), Departement of Orthopaedics Laboratory for Movement Analysis P.O. Box 9600 2300 RC Leiden The Netherlands
Telephone: +31(0)71 5262581
Email: f.steenbrink@lumc.nl
Affiliation: 
Name: J.H.  Groot, de
Address:  Leiden University Medical Center (LUMC), Department of Rehabilitation Medicine, P.O Box 9600 2300 RC Leiden The Netherlands
Telephone: +31 (0)71 5261355
Email: J.H.de_Groot@lumc.nl
Affiliation: 
Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Shoulder disorders

Intervention(s)
Total shoulder replacement
Primary Outcome(s)
1. Component fixation (Rontgen Stereophotographic Analysis (RSA))

2. Shoulderfunctioning (Range of Motion (RoM), Questionnaires for shoulder functioning)
Secondary Outcome(s)
1. Glenohumeral translation (Fluoroscopy)

2. Pain (VAS)

3. Maximum arm force

4. Shoulder coordination (Principal action)

5. Proprosepsis (mirroring)
Secondary ID(s)
ISRCTN42881741
p06.017
Source(s) of Monetary Support
Reumafonds
Secondary Sponsor(s)
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