Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000115932
Ethics application status
Approved
Date submitted
15/09/2010
Date registered
1/02/2011
Date last updated
1/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the accuracy of bone cuts in total knee arthroplasty using custom patient specific cutting blocks
Scientific title
Assessing the accuracy of bone cuts in total knee arthroplasty using Smith & Nephew Visionaire custom patient specific cutting blocks
Secondary ID [1] 252691 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis of the knee 258181 0
Condition category
Condition code
Musculoskeletal 258362 258362 0 0
Osteoarthritis
Surgery 258365 258365 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient Matched Instrumentation(PMI) in Total Knee Arthroplasty (TKA).
All patients will undergo routine pre-operative assessment as well as an Magnetic Resonance Image (MRI) scan & long leg x-rays which are used to make “Visionaire” patient matched disposable cutting blocks (instruments). The cutting blocks are made from pure ‘nylon 12’ material, and are made as a single use disposable item designed to match perfectly the patients anatomy.
At the time of surgery, patients will undergo routine preparation for navigation with computer assisted surgery (CAS) surgery.
Instead of manual placement of a standard cutting blocks under navigation, the Visionaire cutting blocks will then be applied and fixed with standard pins. The position of the blocks will then be referenced to the patients anatomy registered on the CAS, and the data recorded. If the position is inadequate, the blocks will be replaced with standard CAS instruments and the surgery proceed as normal. The surgery will take approximately 90 minutes.
All patients will be assessed post-operatively with standard radiographs including long leg films to assess alignment and verify component position. These will be done by 12 weeks post-op.
Intervention code [1] 257201 0
Treatment: Surgery
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259210 0
intra-operative alignment of cutting blocks as assessed with computer navigation
Timepoint [1] 259210 0
intra-operative
Secondary outcome [1] 265599 0
alignment measured on post-operative radiopraphs
Timepoint [1] 265599 0
12 weeks post-operative

Eligibility
Key inclusion criteria
all patients presenting for total knee arthroplasty who are able to have an Magnetic Resonance Image (MRI) scan
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients unable to have an Magnetic Resonance Image(MRI) scan
previous major surgery about the knee
patients unable to undergo elective surgery

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
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] 257659 0
Commercial sector/Industry
Name [1] 257659 0
Smith & Nephew
Country [1] 257659 0
Australia
Primary sponsor type
Individual
Name
Dr Price Gallie
Address
123 Nerang St
Southport 4215
QLD
Country
Australia
Secondary sponsor category [1] 256875 0
Commercial sector/Industry
Name [1] 256875 0
Smith & Nephew
Address [1] 256875 0
19-25 Khertoum Rd
North Ryde
NSW 2113
Country [1] 256875 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259671 0
Gold Coast Hospital Regional Ethics Comittee
Ethics committee address [1] 259671 0
108 Nerang St Southport 4215 QLD
Ethics committee country [1] 259671 0
Australia
Date submitted for ethics approval [1] 259671 0
Approval date [1] 259671 0
09/12/2009
Ethics approval number [1] 259671 0

Summary
Brief summary
Patient matched instruments use pre-operative MRI and radiographs to produced custom instruments for total knee replacement surgery. We aim to verify the accuracy of these blocks using standard intra-operative navigation with computer assisted surgery, and post-operatively with xray assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31645 0
Address 31645 0
Country 31645 0
Phone 31645 0
Fax 31645 0
Email 31645 0
Contact person for public queries
Name 14892 0
Dr Price Gallie
Address 14892 0
123 Nerang St
Southport
4215 QLD
Country 14892 0
Australia
Phone 14892 0
+617 55913454
Fax 14892 0
Email 14892 0
[email protected]
Contact person for scientific queries
Name 5820 0
Dr Price Gallie
Address 5820 0
123 Nerang St
Southport
4215 QLD
Country 5820 0
Australia
Phone 5820 0
+617 55913454
Fax 5820 0
Email 5820 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.