Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001022954
Ethics application status
Approved
Date submitted
2/09/2011
Date registered
26/09/2011
Date last updated
11/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inflammation and pain post total knee joint replacement surgery in osteoarthritis.
Scientific title
Synovitis and pain post total knee arthroplasty in osteoarthritis.
Secondary ID [1] 262979 0
Nil
Universal Trial Number (UTN)
U1111-1124-2581
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 270701 0
Condition category
Condition code
Musculoskeletal 270877 270877 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ultrasound - an ultrasound of the knee that has undergone replacement surgery will be done during the clinic visit date. Presence of synovitis defined as synovial hypertrophy, synovial fluid and presence of power doppler signal. A single measurement of suprapatellar pouch thickness will also be performed.
Questionnaire - symptoms in osteoarthritis assessing domains of pain, physical function and patient global assessment using the following instruments - WOMAC pain and functional impairment subscale, patient global assesment.
Recruitment will take place from 2nd September 2011 to 31st October 2011.
Only 1 visit is required for the study.
Patients will be recruited from the Joint Assessment Clinic at the Shenton Park Campus of Royal Perth Hospital. Patient's records from the database will be accessed and 25 consecutive patients who report at least moderate pain (using the knee society score) at 2 years post TKA and agree to the study will be recruited
Intervention code [1] 269321 0
Not applicable
Comparator / control treatment
25 consecutive patients - who have undergone knee joint replacement surgery, without pain at 2 years post total knee arthroplasty and agree to the study
Control group
Active

Outcomes
Primary outcome [1] 279557 0
1. Presence of synovitis on ultrasound in patients who report pain
Methods - ultrasound of the knee that has undergone knee replacement surgery
- pain using the WOMAC questionnaire
Timepoint [1] 279557 0
2nd September 2011 to 31st Oct 2011 - one visit only
Secondary outcome [1] 287899 0
Nil
Timepoint [1] 287899 0
Nil

Eligibility
Key inclusion criteria
1. Patients who have undergone knee arthroplasty a minimum of 2 years from the initiation of the study period
2. Patients fulfilling the American College of Rheumatology Classification Criteria for primary knee OA prior to the TKA
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. any known cause for secondary OA (rheumatoid arthritis, seronegative spondyloarthritis, major trauma, congenital disorders, cystral arthropathy and Paget's disease)
2. any history of deep infection in the replaced joint as diagnosed from positive gram stain and/or positive culture result from joint fluid aspirate with overt sepsis
3. any known pain disorder (eg fibromyalgia/pain amplification syndrome)
4. revision surgery (arthrotomy)
5. patients known to the rheumatologists who will be performing the ultrasound

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4436 0
6152
Recruitment postcode(s) [2] 4437 0
6151
Recruitment postcode(s) [3] 4438 0
6062
Recruitment postcode(s) [4] 4439 0
6061
Recruitment postcode(s) [5] 4440 0
6059
Recruitment postcode(s) [6] 4441 0
6107
Recruitment postcode(s) [7] 4442 0
6011
Recruitment postcode(s) [8] 4443 0
6053
Recruitment postcode(s) [9] 4444 0
6004
Recruitment postcode(s) [10] 4445 0
6017
Recruitment postcode(s) [11] 4446 0
6105

Funding & Sponsors
Funding source category [1] 269784 0
Self funded/Unfunded
Name [1] 269784 0
Country [1] 269784 0
Primary sponsor type
Individual
Name
Shereen Ch'ng
Address
Rheumatology Department
Royal Perth Hospital
Shenton Park Campus
6 Selby Street
Shenton Park WA 6008
Country
Australia
Secondary sponsor category [1] 268824 0
Hospital
Name [1] 268824 0
Royal Perth Hospital
Address [1] 268824 0
Clinical Trials Business Unit
Level 5, Colonial House
Wellington Street
Perth WA 6000
Country [1] 268824 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271745 0
Prof Frank van Bockxmeer
Ethics committee address [1] 271745 0
Ethics Office
Room 5105
Level 5, Colonial House
Royal Perth Hospital
WA 6000
Ethics committee country [1] 271745 0
Australia
Date submitted for ethics approval [1] 271745 0
28/03/2011
Approval date [1] 271745 0
14/06/2011
Ethics approval number [1] 271745 0
EC2011/056

Summary
Brief summary
This study is to assess the presence of inflammation in the knee joint that has undergone replacement surgery for osteoarthritis and to correlate the presence of inflammation with pain.
Pain is the most common indication for knee joint replacement surgery yet there are patients who continue to report persistent pain after surgery.
There is evidence that inflammation is common in osteoarthritis and may be associated with pain. To date, we are unaware of evidence of inflammation post knee joint replacement surgery for osteoarthritis of the knee. However, there are reports of joint fluid, which may occur due to inflammation, in the prosthetic knee. We would like to study whether the presence of inflammation correlates with the presence of persistent or unexplained pain post joint replacement surgery.
The information routinely collected for the Joint Replacement Registry will be obtained and in addition, an ultrasound assessment of the knee joint that has undergone replacement surgery will be done. Ultrasound has been used for the investigation and management of patients with musculoskeletal disease for at least 30 years. As there is no radiation risk with ultrasound and no medical intervention used in this study, there are no foreseeable risks involved.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33107 0
Address 33107 0
Country 33107 0
Phone 33107 0
Fax 33107 0
Email 33107 0
Contact person for public queries
Name 16354 0
Shereen Ch'ng
Address 16354 0
Rheumatology Department
Royal Perth Hospital
Shenton Park Campus
6 Selby Street
Shenton Park WA 6008
Country 16354 0
Australia
Phone 16354 0
+6108 93827244
Fax 16354 0
+610893827439
Email 16354 0
shereen.ch'[email protected]
Contact person for scientific queries
Name 7282 0
Shereen Ch'ng
Address 7282 0
Rheumatology Department
Royal Perth Hospital
Shenton Park Campus
6 Selby Street
Shenton Park WA 6008
Country 7282 0
Australia
Phone 7282 0
+610893827244
Fax 7282 0
+610893827439
Email 7282 0
shereen.ch'[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.