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Trial registered on ANZCTR


Registration number
ACTRN12611000698976
Ethics application status
Approved
Date submitted
28/06/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Alignment in Total Knee Replacement: A Randomised Controlled Study Comparing Intramedullary Alignment Systems with Patient Specific Instrumentation
Scientific title
Alignment in Total Knee Replacement: A Randomised Controlled Study Comparing Intramedullary Alignment Systems with Patient Specific Instrumentation
Secondary ID [1] 262508 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee and Total Knee Replacement Surgery 268191 0
Condition category
Condition code
Surgery 268317 268317 0 0
Surgical techniques
Musculoskeletal 268403 268403 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient Matched Instrumentation - ie custom made cutting blocks in preparation for total knee replacement.
Patients undergoing a TKR using the Visionaire technology will have an MRI scan of their knee from which specific cutting blocks will be manufactured to match precisely the architecture of their knee. These cutitng blocks are made from nylon material and are single use for that patient and disposed off after the procedure. The aim of this study is to determine whether the surgical time is reduced along with confirming the accuracy of the technique in terms of overall alignment of the prosthesis. we would expect surgical time to be similar if anything slightly shorter.
Intervention code [1] 266856 0
Treatment: Devices
Intervention code [2] 266925 0
Treatment: Surgery
Comparator / control treatment
Total Knee Replacement using standard intramedullary alignment systems
Control group
Active

Outcomes
Primary outcome [1] 269074 0
We aim to assess the overall alignment of the prosthesis between the group using standard intramedullary alignment systems and the second group using the patient specific instruments (Visionaire). Post-op the patients will undergo a CT scan (Perth Protocol) in order to establish the position of the prosthesis in relation to the femur and tibia.
Timepoint [1] 269074 0
CT scan will be carried out as an inpatient post-op but timing of this is not relevant as we are assessing a static component position within the bone.
Secondary outcome [1] 276897 0
Expense
Timepoint [1] 276897 0
Assessing the expense will involve looking at cost of sterilisation of instruments compared to patient specific instruments and also length of stay for patient in terms of bed days. This process will be priced as operative costs and post-op care estimated after patient discharged.
Secondary outcome [2] 279047 0
Operating Time
Timepoint [2] 279047 0
Completion of closure of the wound and tourniquet release.

Eligibility
Key inclusion criteria
Osteoarthritis of the Knee
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to have MRI

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)
Surgeon assesses patients in outpatient setting as to whether appropriate candidate for TKR. If so then patient and surgeon discuss whether they are happy to enter the trial. Patient is then randomised using a random number schedule to receive either standard preparation technique or Visionaire technology. This randomisation process will be carried out by a registrar off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
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
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267334 0
Commercial sector/Industry
Name [1] 267334 0
Smith and Nephew
Country [1] 267334 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith and Nephew
Address
Smith & Nephew Pty Limited
Suite 7, 567 Newcastle Street
West Perth
Western Australia 6005
Australia
Country
Australia
Secondary sponsor category [1] 266399 0
None
Name [1] 266399 0
Address [1] 266399 0
Country [1] 266399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269317 0
St John Of God Hospital
Ethics committee address [1] 269317 0
St John of God House
Level 3, 177-179 Cambridge Street Wembley WA 6014
Ethics committee country [1] 269317 0
Australia
Date submitted for ethics approval [1] 269317 0
Approval date [1] 269317 0
08/06/2011
Ethics approval number [1] 269317 0

Summary
Brief summary
Alignment of total knee replacement is of importance with regards to the length of survivorship. Currently a rod is passed down the centre of both the tibia and the femur so as that the correct bone cuts are made in order the prosthesis fits the bone in the correct alignment. New technology now exists that enables custom cutting blocks to be manufactured specifically for that individuals patients knee so as the bone cuts made are as accurate as possible. This involves undergoing an MRI scan of the knee and from this the cutting blocks specific for the patients knee are made.
This new technology is used to aid in establishing the correct bone cuts in the tibia and femur and hence ultimately the overall alignment of the knee replacement. The knee replacement used will be the same type in each group and the method of insertion will be the same.
Post-operatively both groups will undergo a CT scan of the knee in order to establish the precise alignment of the knee replacement in relation to bony landmarks. From this we can establish whether or not there is any difference between the two different methods of bone preparation in the overall alignment of the knee replacement.
Trial website
Nil
Trial related presentations / publications
Nil as Yet
Public notes

Contacts
Principal investigator
Name 32808 0
Address 32808 0
Country 32808 0
Phone 32808 0
Fax 32808 0
Email 32808 0
Contact person for public queries
Name 16055 0
Mr Riaz Khan
Address 16055 0
The Joint Studio
Suite 1 Hollywood Medical Centre
85 Monash Avenue
Nedlands
6009
Western Australia
Country 16055 0
Australia
Phone 16055 0
+61 8 93863933
Fax 16055 0
+61 8 93863015
Email 16055 0
[email protected]
Contact person for scientific queries
Name 6983 0
Mr Riaz Khan
Address 6983 0
The Joint Studio
Suite 1 Hollywood Medical Centre
85 Monash Avenue
Nedlands
6009
Western Australia
Country 6983 0
Australia
Phone 6983 0
+61 8 93863933
Fax 6983 0
Email 6983 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.