Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000963224
Ethics application status
Not yet submitted
Date submitted
5/11/2009
Date registered
9/11/2009
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Analysis of partial knee replacements for kneecap (Patella) Osteoarthritis
Scientific title
Medium term survivorship and Functional Analysis of Patellofemoral Resurfacing Arthroplasty for Patellofemoral Osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Osteoarthritis 252135 0
Condition category
Condition code
Musculoskeletal 252341 252341 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patellofemoral resurfacing arthroplasty - This is a type of partial knee replacement surgery that treats the patellofemoral articulation only. It is a permanent surgical intervention used to treat arthritis - THE anticipated lifespan of the Prosthesis is 10- 25 years. The approximate duration of the arthroplasty procedure is 1 hour.
Intervention code [1] 241512 0
Treatment: Devices
Intervention code [2] 241518 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253213 0
Oxford Knee scores - a validated scoring system used to assess pain and function in the knee.
Timepoint [1] 253213 0
pre-operatively, 3 month, 6 month, 1 year , 3 years postoperatively
Secondary outcome [1] 262145 0
Cybex dynamometry- muscle strength testing
Timepoint [1] 262145 0
pre-operative, 3 months, 1 year postoperatively

Eligibility
Key inclusion criteria
Patellofemoral Osteoarthritis - isolated
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Generalized osteoarthritis
Inflammatory arthritis
Body Mass Index > 40 (BMI)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
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] 243984 0
Commercial sector/Industry
Name [1] 243984 0
Smith & Nephew Australia
Country [1] 243984 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew Australia
Address
19 Khartoum Road
North Ryde
NSW 2113
Country
Australia
Secondary sponsor category [1] 251336 0
Hospital
Name [1] 251336 0
Calvary Wakefield Hospital
Address [1] 251336 0
300 Wakefield Street
Adelaide, South Australia
5000
Country [1] 251336 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244091 0
Calvary Wakefield Hospital
Ethics committee address [1] 244091 0
Ethics committee country [1] 244091 0
Date submitted for ethics approval [1] 244091 0
24/11/2009
Approval date [1] 244091 0
Ethics approval number [1] 244091 0

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

Contacts
Principal investigator
Name 30472 0
Address 30472 0
Country 30472 0
Phone 30472 0
Fax 30472 0
Email 30472 0
Contact person for public queries
Name 13719 0
Dr Andrew Comley
Address 13719 0
270 Wakefield Street
Adelaide
SA 5000
Country 13719 0
Australia
Phone 13719 0
+61 8 82364193
Fax 13719 0
Email 13719 0
[email protected]
Contact person for scientific queries
Name 4647 0
Dr Andrew Comley
Address 4647 0
270 Wakefield Street
Adelaide
SA 5000
Country 4647 0
Australia
Phone 4647 0
+61 8 82364193
Fax 4647 0
Email 4647 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.