Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001007224
Ethics application status
Approved
Date submitted
19/11/2009
Date registered
20/11/2009
Date last updated
23/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of proteins involved in the inflammation and pain associated with osteoarthritis of the knee
Scientific title
A study of kinins involved in the inflammation and pain associated with osteoarthritis of the knee
Secondary ID [1] 998 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis(OA) of the knee 243672 0
Condition category
Condition code
Musculoskeletal 239941 239941 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients from Royal Perth hospital with osteoarthritis of the knee will be asked to have some blood tests, an ultrasound examination of their knee and fluid withdrawn from the knee to look for evidence of kallikren kinin proteins involved in inflammation. Consenting participants will undergo a single examination incorporating these tests over a duration of approximately 1 hour.
Intervention code [1] 241221 0
Not applicable
Comparator / control treatment
Non controlled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253305 0
To determine by light and confocal immunocytochemistry, the expression of kallikreins, kininogens, and kinin receptors on neutrophils harvested from the circulation and synovial fluid of patients with OA
Timepoint [1] 253305 0
cross sectional (N/A)
Secondary outcome [1] 262347 0
To determine whether expression of kallikreins, kininogens, and kinin receptors on neutrophils harvested from synovial fluid correlates with joint disease in patients with OA, as determined by Ultrasound and clinical symptoms
Timepoint [1] 262347 0
cross sectional (N/A)
Secondary outcome [2] 262348 0
To determine if expression and localization of kallikreins, kininogens, and kinin receptors in patients with OA correlates with joint disease in patients with OA, as determined by Ultrasound and clinical symptoms
Timepoint [2] 262348 0
cross sectional (N/A)

Eligibility
Key inclusion criteria
*primary knee osteoarthritis (OA), which has been diagnosed based on clinical and radiographic criteria, according to the American College of Rheumatology(knee pain,either age > 50 or morning stiffness < 30 mins or crepitus, osteophytes)
*With radiographic evidence of OA for the studied knee based on retrospective bilateral radiography (within last 12 months): Anterior-posterior view in extension and weight bearing position and “sky-line view”; radiographic changes defined by Kellgren-Lawrence score (I to V)
*Moderately severe symptoms (> or =40/100 on pain Visual Analogue Scale)
*Aged more than 18 years
*Able to provide written informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Contraindication or unwillingness to undergo an Ultrasound scan
*Contraindication or unwillingness to undergo arthrocentesis(including an International normalised ratio greater than 2.0 in subjects on warfarin, or patients on therapeutic dose heparin/ Low Molecular Weight heparin)
*Diagnosis of septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondrosis
*With secondary OA, as defined by The Group for the Respect of Ethics and Excellence in Science: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondrosis
*With injury to the study knee within 6 months of the study start
*With a knee joint replacement (partial or total); osteotomy of the studied joint; with arthroscopy of the studied joint made within 1 year of the study start
*With an intra articular injection of steroids made within 4 weeks and/or intra articular injection of radionuclide made with 3 months prior to study entry

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244053 0
University
Name [1] 244053 0
University of Western Australia
Country [1] 244053 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Postal Address:
GPO Box X2213
Perth, Western Australia, 6001
Country
Australia
Secondary sponsor category [1] 251400 0
None
Name [1] 251400 0
Address [1] 251400 0
Country [1] 251400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258149 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 258149 0
Ethics committee country [1] 258149 0
Australia
Date submitted for ethics approval [1] 258149 0
05/10/2010
Approval date [1] 258149 0
Ethics approval number [1] 258149 0
EC 2009/112

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30150 0
Address 30150 0
Country 30150 0
Phone 30150 0
Fax 30150 0
Email 30150 0
Contact person for public queries
Name 13397 0
Helen Keen
Address 13397 0
Level 3 Medical Research Foundation Building
Royal Perth Hospital
Rear 50 Murray St Perth
Western Australia
6000
Country 13397 0
Australia
Phone 13397 0
+61 8 9224 2244
Fax 13397 0
Email 13397 0
[email protected]
Contact person for scientific queries
Name 4325 0
Helen Keen
Address 4325 0
Level 3 Medical Research Foundation Building
Royal Perth Hospital
Rear 50 Murray St Perth
Western Australia
6000
Country 4325 0
Australia
Phone 4325 0
+61 8 9224 2244
Fax 4325 0
Email 4325 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.