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 design	Randomised controlled trial
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
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

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"	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 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