Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Christine Schutz
ORCID ID
http://orcid.org/0000-0001-5829-4513
Contact details
270 Wakefield St
Adelaide
5000
Australia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ECE006
Study information
Scientific title
Research into sclerostin serum and synovial levels and other factors in osteoarthritis of the knee. An observational study.
Acronym
Study hypothesis
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
Calvary Ethics committee. , 29/05/2013, ref: 13 CHTECR006
Study design
Observational single centre study.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available on this website.
Condition
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
Phase
Drug names
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 trial start date
29/05/2013
Overall trial end date
30/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of OA KL Grade 4
2. Primary knee arthroplasty scheduled.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Rheumatoid arthritis
2. Previous joint surgery for OA
Recruitment start date
24/07/2013
Recruitment end date
23/07/2015
Locations
Countries of recruitment
Australia
Trial participating centre
Calvary Wakefield Hospital
Adelaide
5000
Australia
Sponsor information
Organisation
Calvary Wakefield Hospital
Sponsor details
300 Wakefield Street
Adelaide
5000
Australia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Adelaide University (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Australian Orthopaedic Association
Alternative name(s)
AOA
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
Australia
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
01/02/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list