Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000493044
Ethics application status
Approved
Date submitted
9/06/2010
Date registered
16/06/2010
Date last updated
6/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Knee Functional Flexion Axis (FFA) data acquisition during Total Knee Arthroplasty with Stryker Knee Navigation
Scientific title
A prospective series of Total Knee Arthroplasty patients, undergoing surgery with the use of Stryker Knee Navigation for the aquisition of Functional Flexion Axis (FFA) data.
Secondary ID [1] 251985 0
N/A
Universal Trial Number (UTN)
U1111-1115-4793
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 257550 0
Condition category
Condition code
Musculoskeletal 257711 257711 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the Total Knee Arthroplasty surgical procedure (approximately 90-120 minutes) an extra software window in the navigation computer will be opened to take extra measurements to determine the Functional Flexion Axis.
Intervention code [1] 256639 0
Other interventions
Intervention code [2] 256642 0
Treatment: Devices
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258609 0
Determination of the relationships between the clinical epicondylar axis, posterior condylar axis and functional flexion axis of the knee. This will be assessed via comparison of measurements taken with the navigation computer and the pre-operative Computed Tomography (CT) scan.
Timepoint [1] 258609 0
Pre-Operative CT scan (once only)
Intra-Operative (once only)
Secondary outcome [1] 264518 0
Nil
Timepoint [1] 264518 0
Nil

Eligibility
Key inclusion criteria
Patients requiring unilateral or bilateral computer assisted knee arthroplasty.

Non-pregnant females.

Over 18 years of age at time of surgery.

Patients who understand the conditions of the study and are willing to participate.

Patients who are capable of, and have given, written informed consent to their participation in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable or unwilling to undergo a computerised
tomography scan.

Patients that suffer claustrophobia.

Patients less than 18 years of age at the time of 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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/12/2009
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)

Funding & Sponsors
Funding source category [1] 257119 0
Commercial sector/Industry
Name [1] 257119 0
Stryker Australia Pty Ltd
Country [1] 257119 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd
Address
8 Herbert St
St. Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 256380 0
None
Name [1] 256380 0
Address [1] 256380 0
Country [1] 256380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259160 0
North Sydney Central Coast Health (Harbour) Human Research Ethics Committee (HREC)
Ethics committee address [1] 259160 0
Research Business Unit
Level 2, Building 51
Royal North Shore Hospital
St. Leonards NSW 2065
Ethics committee country [1] 259160 0
Australia
Date submitted for ethics approval [1] 259160 0
06/04/2009
Approval date [1] 259160 0
19/11/2009
Ethics approval number [1] 259160 0
HREC/09/HARBR/39

Summary
Brief summary
Computer assisted surgery has been developed to assist in obtaining ideal alignment of knee replacement prosthesis in patients with advanced knee osteoarthritis. Obtaining the precise positioning during sugery can be difficult. Using intraoperative dynamic movement of the knee a computer can take into account three dimensions and obtain a true "functional flexion axis" (FFA) of the knee which may more closely represent the true anatomical axis
of the knee.
This study will assess whether measurement of the "functional flexion axis" of the knee during surgery using
specialised computer software is closely related to the Trans-Epicondylar Axis (TEA) obtained from an Computed tomography (CT) scan.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31278 0
Address 31278 0
Country 31278 0
Phone 31278 0
Fax 31278 0
Email 31278 0
Contact person for public queries
Name 14525 0
Dr Tim Barker
Address 14525 0
Stryker Australia
8 Herbert St
St. Leonards
NSW 2065
Country 14525 0
Australia
Phone 14525 0
+61 2 6467 1000
Fax 14525 0
Email 14525 0
tim.barker@stryker.com
Contact person for scientific queries
Name 5453 0
Dr Tim Barker
Address 5453 0
Stryker Australia
8 Herbert St
St. Leonards
NSW 2065
Country 5453 0
Australia
Phone 5453 0
+61 2 9467 1000
Fax 5453 0
Email 5453 0
tim.barker@stryker.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.