The study of bone cells specifically in osteoarthritis and factors affecting progression
| ISRCTN | ISRCTN12207865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12207865 |
| Secondary identifying numbers | ECE006 |
- Submission date
- 02/06/2015
- Registration date
- 15/06/2015
- Last edited
- 15/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Sclerostin is a small protein made by osteocytes (bone cells). It is thought that higher levels of sclerostin may indicate a more progressive osteoarthritis. Here, we want to investigate whether there are any differences in the sclerostin levels in blood and joints of patients undergoing knee replacement surgery (knee arthroplasty) and record other clinical parameters such as pain, function and histological grading of the osteoarthritis. The aim of this study is to investigate the role of the osteocytes in bone disease such as osteoarthritis and to understand the mechanisms that can occur that sometimes contribute to bone loosening around a prosthesis.
Who can participate?
Adults scheduled to have a knee replacement due to osteoarthritis.
What does the study involve?
A small sample of bone that would otherwise be removed and discarded is taken from each participant at the time of their knee replacement surgery. A blood sample is taken at the same time. Both samples are then taken for analysis.
What are the possible benefits and risks of participating?
The bone will only be used for research and the results will not have any effect on health or treatment.
Where is the study run from?
Calvary Wakefield Hospital (Australia)
When is the study starting and how long is it expected to run for?
May 2013 to July 2017
Who is funding the study?
The Australian Orthopaedic Association and Adelaide University (Australia)
Who is the main contact?
Dr Christine Schutz
Contact information
Scientific
270 Wakefield St
Adelaide
5000
Australia
 ORCID ID |
0000-0001-5829-4513 |
|---|
Study information
| Study design | Observational single centre study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available on this website. |
| Scientific title | Research into sclerostin serum and synovial levels and other factors in osteoarthritis of the knee. An observational study. |
| Study objectives | Sclerostin is produced almost exclusively by osteocytes that regulate bone mass. It is hypothesized that higher levels of sclerostin may indicate a more progressive osteoarthritis.. This study aims to observe if there are any differences in serum sclerostin and synovial sclerostin in patients undergoing knee arthroplasty and record other clinical parameters such as pain and function and histological grading of osteoarthritis (OA). |
| Ethics approval(s) | Calvary Ethics committee. , 29/05/2013, ref: 13 CHTECR006 |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee and its progression. |
| Intervention | All patients will have diagnosis of Grade 4 OA and consent to bone and blood samples being taken at time of primary knee arthroplasty. The observations are done pre surgery and serum and synovial fluid analysis is at time of surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Whether another joint required replacement due to OA 12 months after surgery. Number of days recorded between surgeries if < 12months 2. Are serum sclerostin or synovial sclerostin levels higher in those with progressive OA defined by additional surgery < 12 months from initial surgery. High sclerostin levels in serum and synovial fluid indicate a progressive form of OA |
| Secondary outcome measures | To identify if any other factors such as Vit D levels and obesity contribute to variable sclerostin levels. Vitamin D levels evaluated pre surgery and 12month postoperatively. |
| Overall study start date | 29/05/2013 |
| Completion date | 30/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Diagnosis of OA KL Grade 4 2. Primary knee arthroplasty scheduled. |
| Key exclusion criteria | 1. Rheumatoid arthritis 2. Previous joint surgery for OA |
| Date of first enrolment | 24/07/2013 |
| Date of final enrolment | 23/07/2015 |
Locations
Countries of recruitment
- Australia
Study participating centre
5000
Australia
Sponsor information
Hospital/treatment centre
300 Wakefield Street
Adelaide
5000
Australia
| Website | www.calvarycare.org.au |
|---|---|
"ROR" |
https://ror.org/02gt91x70 |
Funders
Funder type
Hospital/treatment centre
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- AOA
- Location
- Australia
Results and Publications
| Intention to publish date | 01/02/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
