Contact information
Type
Scientific
Primary contact
Dr Robert Bruce Litchfield
ORCID ID
Contact details
Fowler Kennedy Sport Medicine Clinic
3M Centre
University of Western Ontario
London
N6A 3K7
Canada
+1 519 661 4156
rlitchf@uwo.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UCT-48088
Study information
Scientific title
Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis: a randomised controlled trial
Acronym
Study hypothesis
Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.
Ethics approval
Review Board for Health Sciences Research Involving Human Subjects in the University of Western Ontario gave approval on the 25th April 2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary osteoarthritis of the shoulder
Intervention
Group 1: Cemented fixation of the humeral component in total shoulder arthroplasty
Group 2: Uncemented fixation of the humeral component in total shoulder arthroplasty
Trial details received: 12 Sept 2005
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The main evaluation of patient outcome is disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Constant Score and American Shoulder and Elbow Surgeons (ASES) Standardised Shoulder Assessment form. Overall global health status will be measured and compared at 2 years using the Short Form-12 which has previously been shown to be the most appropriate instrument for evaluating global health status in orthopaedic clinical research.
Secondary outcome measures
The evaluation of radiolucent lines indicative of implant loosening and the incidence of revision surgery complications will be monitored during the 2 year post-operative course.
Overall trial start date
01/04/2002
Overall trial end date
30/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder)
2. Aged 18 years and older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
Patients who have failed standard conservative management of their shoulder osteoarthritis
Recruitment start date
01/04/2002
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Fowler Kennedy Sport Medicine Clinic
London
N6A 3K7
Canada
Sponsor information
Organisation
The University of Western Ontario (Canada)
Sponsor details
Research Accounting
SLB
UWO
1151 Richmond Street North
London
N6A 5B8
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-48088)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Zimmer (Canada)
Alternative name(s)
Zimmer, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Alternative name(s)
Zimmer, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Zimmer (USA)
Alternative name(s)
Zimmer, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Alternative name(s)
Zimmer, Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
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
Basic results (scientific)
Publication list