Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000537055
Ethics application status
Approved
Date submitted
30/06/2010
Date registered
2/07/2010
Date last updated
2/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Alignment Following Total Knee Replacement:
A Randomised Control Trial Comparing Computer Assisted Surgery with Patient Matched Instrumentation
Scientific title
A Randomised Trial Comparing Computer Assisted Surgery with Patient Matched Instrumentation on Alignment following Total Knee Arthroplasty
Secondary ID [1] 252138 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 257670 0
Rheumatoid Arthritis 257682 0
Condition category
Condition code
Inflammatory and Immune System 257850 257850 0 0
Rheumatoid arthritis
Surgery 257863 257863 0 0
Surgical techniques
Musculoskeletal 257864 257864 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient Matched Instrumentation uses pre-operative imaging of the patient’s knee to create patient- specific cutting blocks modelled to the patient’s bone. These are used at the time of surgery.
Intervention code [1] 256740 0
Treatment: Surgery
Comparator / control treatment
Computer Assisted Surgery uses computer guidance to align cutting blocks at the time of surgery.
Control group
Active

Outcomes
Primary outcome [1] 258714 0
Knee alignment using Computed Tomography Scan
Timepoint [1] 258714 0
6 weeks post surgery
Secondary outcome [1] 264744 0
Time of surgery from first incision to application of dressings timed using a clock.
Timepoint [1] 264744 0
Time of surgery from first incision to application of dressings.

Eligibility
Key inclusion criteria
Requiring primary total knee arthroplasty
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deformity of tibia or femur.

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)
Information about trial will be given to patients in the Orthopaedic Outpatients Clinic and then, informed consent will be obtained. Once patients are recruited and enrolled, randomisation will occur in the Outpatient clinic- with the surgeon choosing the next sequentially-numbered sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated, random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
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] 3021 0
6009

Funding & Sponsors
Funding source category [1] 257226 0
Hospital
Name [1] 257226 0
Sir Charles Gairdner Hospital
Country [1] 257226 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 256474 0
None
Name [1] 256474 0
Address [1] 256474 0
Country [1] 256474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259247 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 259247 0
Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 259247 0
Australia
Date submitted for ethics approval [1] 259247 0
01/08/2009
Approval date [1] 259247 0
09/11/2009
Ethics approval number [1] 259247 0

Summary
Brief summary
A randomised controlled trial is required to compare Computer assisted surgery with Patient Matched Instrumentation to see which provides best alignment with minimal operating time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31354 0
Address 31354 0
Country 31354 0
Phone 31354 0
Fax 31354 0
Email 31354 0
Contact person for public queries
Name 14601 0
Will Blakeney
Address 14601 0
Sir Charles Gairdner Hospital
Dept Orthopaedic Surgery
Hospital Avenue
Nedlands
WA 6009
Country 14601 0
Australia
Phone 14601 0
+61893461499
Fax 14601 0
Email 14601 0
tibialalignment@gmail.com
Contact person for scientific queries
Name 5529 0
Will Blakeney
Address 5529 0
Sir Charles Gairdner Hospital
Dept Orthopaedic Surgery
Hospital Avenue
Nedlands
WA 6009
Country 5529 0
Australia
Phone 5529 0
+61893461499
Fax 5529 0
Email 5529 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.