Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000960257
Ethics application status
Approved
Date submitted
5/11/2009
Date registered
6/11/2009
Date last updated
6/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cruciate Retaining vs Posterior Stabilised Total Knee Replacement: A Randomised Clinical Trial
Scientific title
A randomised trial to compare a cruciate retaining prosthesis with a posterior stabilised prosthesis for functional outcomes in total knee arthroplasty
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 252131 0
Rheumatoid arthritis 252132 0
Condition category
Condition code
Inflammatory and Immune System 252339 252339 0 0
Rheumatoid arthritis
Musculoskeletal 252342 252342 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient will undergo total knee arthroplasty. The prosthesis used will be a posterior stabilised device. The operation will take 2 hours.
Intervention code [1] 241510 0
Treatment: Surgery
Comparator / control treatment
Patient will undergo total knee arthoplasty. The prosthesis used will be a cruciate retaining device. The operation will take 2 hours.
Control group
Active

Outcomes
Primary outcome [1] 253210 0
Oxford Knee Score (OKS). This assesses knee function.
Timepoint [1] 253210 0
2 weeks, 6 weeks, 3 months, 12 months, 2 years, 5 years and 10 years post-operatively
Primary outcome [2] 253211 0
Active Range of Motion in degrees measured with a goniometer
Timepoint [2] 253211 0
2 weeks, 6 weeks, 3 months, 12 months, 2 years, 5 years and 10 years post-operatively
Secondary outcome [1] 262142 0
6 minute walk test. This tests the distance a patient can walk in 6 minutes
Timepoint [1] 262142 0
2 weeks, 6 weeks, 3 months, 12 months, 2 years, 5 years and 10 years post-operatively

Eligibility
Key inclusion criteria
Primary total knee replacement
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the trial for tibial deformity (including past fracture or high tibial osteotomy) or valgus deformity.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243982 0
Self funded/Unfunded
Name [1] 243982 0
Country [1] 243982 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 251334 0
None
Name [1] 251334 0
Address [1] 251334 0
Country [1] 251334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244089 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 244089 0
Ethics committee country [1] 244089 0
Australia
Date submitted for ethics approval [1] 244089 0
Approval date [1] 244089 0
07/10/2009
Ethics approval number [1] 244089 0

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

Contacts
Principal investigator
Name 30470 0
Address 30470 0
Country 30470 0
Phone 30470 0
Fax 30470 0
Email 30470 0
Contact person for public queries
Name 13717 0
Riaz Khan
Address 13717 0
Department of Orthopaedics
Hospital Avenue
Nedlands
WA 6009
Country 13717 0
Australia
Phone 13717 0
+618 93461499
Fax 13717 0
Email 13717 0
tibialalignment@gmail.com
Contact person for scientific queries
Name 4645 0
Riaz Khan
Address 4645 0
Department of Orthopaedics
Hospital Avenue
Nedlands
WA 6009
Country 4645 0
Australia
Phone 4645 0
+618 93461499
Fax 4645 0
Email 4645 0
tibialalignment@gmail.com

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.