Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis

ISRCTN ISRCTN75566721
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

Fowler Kennedy Sport Medicine Clinic
3M Centre
University of Western Ontario
London
N6A 3K7
Canada

Phone +1 519 661 4156
Email rlitchf@uwo.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis: a randomised controlled trial
Study objectivesOur 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) studiedPrimary osteoarthritis of the shoulder
InterventionGroup 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 typeOther
Primary outcome measureThe 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 measuresThe 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 date01/04/2002
Completion date30/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Key inclusion criteria1. 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 criteriaPatients who have failed standard conservative management of their shoulder osteoarthritis
Date of first enrolment01/04/2002
Date of final enrolment30/04/2009

Locations

Countries of recruitment

  • Canada

Study participating centre

Fowler Kennedy Sport Medicine Clinic
London
N6A 3K7
Canada

Sponsor information

The University of Western Ontario (Canada)
University/education

Research Accounting, SLB, UWO
1151 Richmond Street North
London
N6A 5B8
Canada

Website http://www.uwo.ca/
ROR logo "ROR" 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)
Alternative name(s)
Zimmer, Inc., Zimmer Biomet
Location
United States of America
Zimmer (USA)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan