Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis
| ISRCTN | ISRCTN75566721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75566721 |
| Protocol serial number | UCT-48088 |
| Sponsor | The University of Western Ontario (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-48088), Zimmer (Canada), Zimmer (USA) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Fowler Kennedy Sport Medicine Clinic
3M Centre
University of Western Ontario
London
N6A 3K7
Canada
| Phone | +1 519 661 4156 |
|---|---|
| rlitchf@uwo.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
N6A 3K7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
