Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis
ISRCTN | ISRCTN75566721 |
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DOI | https://doi.org/10.1186/ISRCTN75566721 |
Secondary identifying numbers | UCT-48088 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 04/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Bruce Litchfield
Scientific
Scientific
Fowler Kennedy Sport Medicine Clinic
3M Centre
University of Western Ontario
London
N6A 3K7
Canada
Phone | +1 519 661 4156 |
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rlitchf@uwo.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis: a randomised controlled trial |
Study objectives | 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(s) | Review Board for Health Sciences Research Involving Human Subjects in the University of Western Ontario gave approval on the 25th April 2001 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/04/2002 |
Completion date | 30/04/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 160 |
Key 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 |
Key exclusion criteria | Patients who have failed standard conservative management of their shoulder osteoarthritis |
Date of first enrolment | 01/04/2002 |
Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Fowler Kennedy Sport Medicine Clinic
London
N6A 3K7
Canada
N6A 3K7
Canada
Sponsor information
The University of Western Ontario (Canada)
University/education
University/education
Research Accounting, SLB, UWO
1151 Richmond Street North
London
N6A 5B8
Canada
Website | http://www.uwo.ca/ |
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https://ror.org/02grkyz14 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-48088)
No information available
Zimmer (Canada)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Zimmer, Inc., Zimmer Biomet
- Location
- United States of America
Zimmer (USA)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Zimmer, Inc., Zimmer Biomet
- Location
- United States of America
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |