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Trial registered on ANZCTR


Registration number
ACTRN12613000936729
Ethics application status
Not yet submitted
Date submitted
21/08/2013
Date registered
26/08/2013
Date last updated
26/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the accuracy of Total Knee Replacement's (TKR's) performed using patient matched technology by computed tomography
Scientific title
The effect of patient-matched instrumentation on degree of alignment achieved postoperatively in patients undergoing total knee replacement for osteoarthritis
Secondary ID [1] 283052 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 289891 0
Condition category
Condition code
Musculoskeletal 290256 290256 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient matched total knee replacement involves a preoperative CT scan which is then processed by the manufacturer to produce a preliminary preoperative report outlining proposed resection levels. This is then reviewed by the surgical team and, if approved, is then sent back to the manufacturer where the custom made cutting block is manufactured.

During surgery, the cutting block is attached directly to the patients bony anatomy during and promotes accurate resection of the both the femoral and tibial bones. The procedure takes approximately 60 minutes.

The system used in this study will include but is not limited to Medacta Orthopaedic patient matched knee system-MyKnee Registered Trademark. Proposed benefits of this system include improved accuracy, reduced cost and decreased operating times.
Intervention code [1] 287773 0
Treatment: Surgery
Intervention code [2] 287790 0
Treatment: Devices
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290276 0
1. Identify the mechanical axis of the limb in the coronal anteroposterior and sagittal lateral planes measured by a CT scan.
Timepoint [1] 290276 0
Measured preoperatively and within 7 days following total knee replacement surgery
Primary outcome [2] 290308 0
2.Calculate the varus/valgus positioning of the femoral component and tibial components using a CT scan .
Timepoint [2] 290308 0
Measured preoperatively and within 7 days following total knee replacement surgery
Primary outcome [3] 290309 0
3. Determine the flexion/extension of the posterior flange of the femoral component using a CT scan.
Timepoint [3] 290309 0
Measured preoperatively and within 7 days following total knee replacement surgery
Secondary outcome [1] 304238 0
Nil
Timepoint [1] 304238 0
Nil

Eligibility
Key inclusion criteria
1. The individual has read and understood the patient information statement (PIS) and signed a consent form specific to this study.
2. The individual is over 18 years of age.
3. The individual has been given a primary diagnosis of osteoarthritis.
4. The individual clinically qualifies for total knee arthroplasty surgery based on physical examination and medical history.
5. The individual is physically and mentally willing and able to comply with scheduled clinical and radiographic evaluations (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse).
6. The individual does not have a systemic disease that would affect their welfare or the overall outcome of the study, is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
7. The individual is skeletally mature.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The individual is unable or unwilling to read the patient information statement (PIS) and sign the consent form specific to this study.
2. The individual has had a previous fracture of the femoral condyles, tibia plateau, or femora/tibial shaft.
3. The individual has had a previous osteotomy around the knee.
4. The individual is physically or mentally compromised (i.e., is currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse), and is unable to comply with scheduled clinical and radiographic evaluations.
5. The individual has a neuromuscular or neurosensory deficiency which limits their ability to evaluate the safety and effectiveness of the device.
6. The individual has an active infection within the affected joint.
7. The individual has had a previous total knee replacement.
8. The individual is pregnant.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be collected in paper case report forms (CRFs). The data will then be entered on Microsoft excel software. The percentage of patients who have reached the level of accuracy outlined in the preoperative planning report will be calculated.

There will be no formal sample size analysis for this study. A sample population of 50 patients should provide an appropriate number to allow a robust analysis of the accuracy of patient matched cutting blocks, and is in excess to patient numbers used in similar studies performed previously.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1450 0
Campbelltown Private Hospital - Campbelltown
Recruitment postcode(s) [1] 7282 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 287816 0
Self funded/Unfunded
Name [1] 287816 0
Dr Arash Nabavi
Address [1] 287816 0
105-119 Longstaff Avenue, Chipping Norton NSW, 2170.
Country [1] 287816 0
Australia
Primary sponsor type
Individual
Name
Dr. Arash Nabavi
Address
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue,
Chipping Norton NSW, 2170.
Country
Australia
Secondary sponsor category [1] 286545 0
None
Name [1] 286545 0
Address [1] 286545 0
Country [1] 286545 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289764 0
University of New South Wales
Ethics committee address [1] 289764 0
Human Research Ethics Committee
Grants Management Office
Level 3, Rupert Myers Building South Wing
University of New South Wales
Kensington Campus NSW 2052
Ethics committee country [1] 289764 0
Australia
Date submitted for ethics approval [1] 289764 0
03/09/2013
Approval date [1] 289764 0
Ethics approval number [1] 289764 0

Summary
Brief summary
Malalignment in total knee replacement is a major cause of failure. Traditionally, alignment is facilitated through the use of mechanical jigs to position cutting blocks. There is however debate as to the accuracy of such jig systems. This study will employ a relatively new alternative method in which patient matched instrumentation as opposed to conventional jig-assisted techniques are used.

This study will look at the accuracy of TKR’s performed using instrumentation which is specific to the patient. A CT scan will be performed on the patients’ knee after the operation to assess how accurate this patient specific instrumentation is.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42302 0
Dr Arash Nabavi
Address 42302 0
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue
Chipping Norton
NSW 2170
Country 42302 0
Australia
Phone 42302 0
+61 (02) 9821 2599
Fax 42302 0
Email 42302 0
nabaviarash@optusnet.com.au
Contact person for public queries
Name 42303 0
Ms Caroline Olwill
Address 42303 0
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue
Chipping Norton
NSW 2170
Country 42303 0
Australia
Phone 42303 0
+61 (02) 9821 2599
Fax 42303 0
Email 42303 0
caroline.olwill@sbjc.com.au
Contact person for scientific queries
Name 42304 0
Dr Arash Nabavi
Address 42304 0
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue
Chipping Norton
NSW 2170
Country 42304 0
Australia
Phone 42304 0
+61 (02) 9821 2599
Fax 42304 0
Email 42304 0
nabaviarash@optusnet.com.au

No information has been provided regarding IPD availability
Summary results
No Results