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Trial registered on ANZCTR


Registration number
ACTRN12610000360011
Ethics application status
Not yet submitted
Date submitted
29/04/2010
Date registered
6/05/2010
Date last updated
6/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
All-Polyethylene versus Metal-Backed Total Knee Joint Replacements in patients with osteoarthritis
Scientific title
What are post-operative functional and clinical outcome differences between all-polyethylene and metal-backed tibial implants for knee joint replacements in patients with osteoarthritis?
Secondary ID [1] 251683 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee joint replacement - all-polyethylene vs. metal-backed tibial implants 257267 0
Condition category
Condition code
Musculoskeletal 257415 257415 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised insertion of All-polyethylene tibial implant or metal-backed implant. The control (metal-backed implant) would involve a metal tibial implant which would require an all-polyethylene insert. The all-polyethylene implant incorporates the usual polyethylene insert to the tibial implant, becoming an 'all-poly' tibial implant. The procedure (total knee joint replacement) takes approximately 90 minutes, regardless of the implant used. Total knee joint replacements can last up to and beyond 10 years, or until any component fails.
Intervention code [1] 256386 0
Treatment: Surgery
Intervention code [2] 256425 0
Treatment: Devices
Comparator / control treatment
Metal-backed implant group. The metal-backed implant is a colbalt-chromium tibial implant that requires a polyethylene insert to fit on top, for contact with the femoral component. The procedure (total knee joint replacement) takes approximately 90 minutes, regardless of the implant used. Total knee joint replacements can last up to and beyond 10 years, or until any component fails.
Control group
Active

Outcomes
Primary outcome [1] 258331 0
Functional outcome as determined by clinical scores: Western Ontario and McMaster Universities Arthritis Index (WOMAC), Short Form 36 (SF 36), Knee Society Score (KSS)
Timepoint [1] 258331 0
6 weeks, 6 months, 1 year, post-operatively, and then yearly thereafter. The end point shall be for the rest of the patients' life. (This is the usual standard of care for the primary investigators protocol of following up total joint replacements)
Secondary outcome [1] 264050 0
Range of Motion of the operated knee using a goniometer, by the clinic nurse.
Timepoint [1] 264050 0
6 weeks, 6 months, 1 year, post-operatively, and then yearly thereafter. The end point shall be for the rest of the patients' life. (This is the usual standard of care for the primary investigators protocol of following up total joint replacements)yearly thereafter

Eligibility
Key inclusion criteria
All patients offered total knee joint replacement at participating hospital
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring complex surgery (e.g. involving grafting, augments). Patients with previous infection in the knee joint to be replaced. Patients not consenting to participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled from outpatient clinics when they are offered total knee joint replacement surgery. The surgeon will have decided which brand of implant to use, but not whether it will be an all-polyethylene or a metal-backed tibial implant. Randomisation will occur in theatre, using calculator-generated random numbers. Neither the surgeons nor the patients can be blinded. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A calculator generating random numbers will be used. The first number of the sequence will determine whether the implant to be used is an all polyethylene or a metal-backed. Even numbers shall represent all polyethylene and odd numbers, metal backed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2606 0
New Zealand
State/province [1] 2606 0
South Canterbury

Funding & Sponsors
Funding source category [1] 256888 0
Self funded/Unfunded
Name [1] 256888 0
Country [1] 256888 0
Primary sponsor type
Individual
Name
Georgina Chan
Address
c/o Waikato Public Hospital
Pembroke Street
Hamilton East
Hamilton 3210
Country
New Zealand
Secondary sponsor category [1] 256162 0
Individual
Name [1] 256162 0
Dave Templeton
Address [1] 256162 0
c/o Timaru Public Hospital
Queen Street
Timaru 7910
Country [1] 256162 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258901 0
Ethics committee address [1] 258901 0
Ethics committee country [1] 258901 0
Date submitted for ethics approval [1] 258901 0
30/05/2010
Approval date [1] 258901 0
Ethics approval number [1] 258901 0

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

Contacts
Principal investigator
Name 31108 0
Address 31108 0
Country 31108 0
Phone 31108 0
Fax 31108 0
Email 31108 0
Contact person for public queries
Name 14355 0
Georgina Chan
Address 14355 0
c/o Waikato Public Hospital
Pembroke Street
Hamilton East
Hamilton 3210
Country 14355 0
New Zealand
Phone 14355 0
+6478398799
Fax 14355 0
Email 14355 0
[email protected]
Contact person for scientific queries
Name 5283 0
Georgina Chan
Address 5283 0
c/o Waikato Public Hospital
Pembroke Street
Hamilton East
Hamilton 3210
Country 5283 0
New Zealand
Phone 5283 0
+6478398799
Fax 5283 0
Email 5283 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.