Condition category
Musculoskeletal Diseases
Date applied
02/06/2015
Date assigned
15/06/2015
Last edited
15/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.calvarycare.org.au

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes