Contact information
Type
Scientific
Primary contact
Dr F Steenbrink
ORCID ID
Contact details
Leiden University Medical Center
Departement of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31(0)71 526 2581
f.steenbrink@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
p06.017
Study information
Scientific title
Acronym
Study 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).
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Shoulder disorders
Intervention
Total shoulder replacement
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Component fixation (Rontgen Stereophotographic Analysis [RSA])
2. Shoulder functioning (Range of Motion [RoM], Questionnaires for shoulder functioning)
Secondary outcome measures
1. Glenohumeral translation (Fluoroscopy)
2. Pain (Visual Analogue Scale [VAS])
3. Maximum arm force
4. Shoulder coordination (Principal action)
5. Proprosepsis (mirroring)
Overall trial start date
01/11/2006
Overall trial end date
01/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Individuals requiring primary arthroplasty as a result of osteoarthritis or rheumatoid arthritis.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Rotator cuff tear, pre-operatively diagnosed by means of Magnetic Resonance Imaging (MRI)
2. Humeral component with a radius of 20 mm
3. Prior history of shoulder surgery
Recruitment start date
01/11/2006
Recruitment end date
01/11/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (LUMC) (The Netherlands)
Sponsor details
Department of Orthopaedics
Laboratory for Movement Analysis
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html
Funders
Funder type
Industry
Funder name
Reumafonds (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary