Condition category
Musculoskeletal Diseases
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
04/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.uwo.ca/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes