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Trial registered on ANZCTR
Registration number
ACTRN12612000243819
Ethics application status
Approved
Date submitted
22/02/2012
Date registered
27/02/2012
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Date results information initially provided
14/01/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Acetabular cup placement in participants requiring total hip replacement or hip resurfacing surgery using the MACNAV navigation system.
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Scientific title
A multicentre, randomised, pilot clinical trial to assess the accuracy of acetabular cup positioning using the MACNAV system versus standard positioning techniques in participants requiring hip replacement
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Secondary ID [1]
280005
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IONS-CIP-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip joint replacement.
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Condition category
Condition code
Musculoskeletal
286104
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0
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Osteoarthritis
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Surgery
286133
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will undergo a standard hip replacement procedure. The MACNAV system will be used to align the acetabular cup into the acetabulum using an electronic module which can be programmed to the surgeon’s pre-defined angles of inclination and angulation. The femoral component will be implanted using standard techniques. The device is used during initial implant only and is anticipated to take no more than an additional 5 minutes of operation time.
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Intervention code [1]
284330
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Treatment: Devices
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Intervention code [2]
284355
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Treatment: Surgery
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Comparator / control treatment
Standard operative technique for implanting the acetabular component. Standard operating techniques include impacting the acetabular cup using other navigation systems or no navigation i.e. by hand where the surgeon estimates the correct angles, however, may vary depending on the surgeon.
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Control group
Active
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Outcomes
Primary outcome [1]
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Acetabular cup position. Cup positioning will be evaluated by post operative CT scan examination by one blinded radiographer (blinded to treatment).
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Assessment method [1]
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Timepoint [1]
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Post procedure follow-up visit. Scheduling of this visit may occur anytime between 2 and 6 weeks post procedure and will be a single follow-up visit only.
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Secondary outcome [1]
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Proportion of acetabular cups implanted within 10 degrees of the optimal angle (defined by each surgeon). Cup positioning will be evaluated by post operative CT scan examination by one blinded radiographer (blinded to treatment).
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Assessment method [1]
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Timepoint [1]
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Post procedure follow-up visit. Scheduling of this visit may occur anytime between 2 and 6 weeks post procedure and will be a single follow-up visit only.
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Secondary outcome [2]
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Adverse event rates. Adverse event rate that may occur with this type of surgery include infection and deep vein thrombosis. Adverse event rates will compared between control and active (MACNAV groups) and to those rates commonly seen in hip replacement surgery.
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Assessment method [2]
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Timepoint [2]
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Between surgery and 6 months post surgery.
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Secondary outcome [3]
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Surgical feedback regarding ease of use of the system. The surgeon will be asked to complete a tailored questionnaire to assess this outcome.
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Assessment method [3]
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Timepoint [3]
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Day of surgery.
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Eligibility
Key inclusion criteria
Participant requires hip replacement, no prior hip replacement surgery, willing and able to provide informed consent, not pregnant.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cannot comply with follow-up CT scan.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
22/02/2012
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Actual
14/03/2013
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Date of last participant enrolment
Anticipated
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Actual
25/08/2014
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Date of last data collection
Anticipated
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Actual
24/02/2015
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Sample size
Target
60
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Luke's Hospital - Potts Point
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Recruitment hospital [2]
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Norwest Private Hospital - Bella Vista
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Recruitment postcode(s) [1]
29015
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2011 - Potts Point
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Recruitment postcode(s) [2]
29016
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2153 - Bella Vista
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Inertial Orthopaedic Navigation Solutions
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Address [1]
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c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Inertial Orthopaedic Navigation Solutions
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Address
c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
283655
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry
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Ethics committee address [1]
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123 Glen Osmond Rd,
Eastwood SA 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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09/03/2011
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Approval date [1]
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11/04/2011
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Ethics approval number [1]
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2011-02-073
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Summary
Brief summary
The purpose of the study is to assist surgeons in aligning the acetabular cup in the acetabulum. By having a better alignment there is a potential for a reduction in post operative complications such as hip dislocation, and loosening of the prosthesis. The study hopes to show that by using the navigation device, surgeons are able to align the device with more accuracy than by using standard operative techniques.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Lawrence Kohan
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Address
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Joint Orthopaedic Centre, Suite 301C, 9-13 Bronte Road, Bondi Junction, 2022, NSW
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Country
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Australia
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Phone
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+61 2 9387 2877
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Bob Lye
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Address
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c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
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Country
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Australia
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Phone
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+61 2 9939 0900
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Bob Lye
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Address
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c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
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Country
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Australia
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Phone
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+61 2 9939 0900
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Trial abandoned
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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.
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