Trial Review

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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
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.
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
Secondary ID [1] 280005 0
IONS-CIP-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip joint replacement. 285914 0
Condition category
Condition code
Musculoskeletal 286104 286104 0 0
Osteoarthritis
Surgery 286133 286133 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284330 0
Treatment: Devices
Intervention code [2] 284355 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 286582 0
Acetabular cup position. Cup positioning will be evaluated by post operative CT scan examination by one blinded radiographer (blinded to treatment).
Timepoint [1] 286582 0
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.
Secondary outcome [1] 296214 0
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).
Timepoint [1] 296214 0
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.
Secondary outcome [2] 296215 0
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.
Timepoint [2] 296215 0
Between surgery and 6 months post surgery.
Secondary outcome [3] 296216 0
Surgical feedback regarding ease of use of the system. The surgeon will be asked to complete a tailored questionnaire to assess this outcome.
Timepoint [3] 296216 0
Day of surgery.

Eligibility
Key inclusion criteria
Participant requires hip replacement, no prior hip replacement surgery, willing and able to provide informed consent, not pregnant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot comply with follow-up CT scan.

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)
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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
22/02/2012
Actual
14/03/2013
Date of last participant enrolment
Anticipated
Actual
25/08/2014
Date of last data collection
Anticipated
Actual
24/02/2015
Sample size
Target
60
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15615 0
St Luke's Hospital - Potts Point
Recruitment hospital [2] 15616 0
Norwest Private Hospital - Bella Vista
Recruitment postcode(s) [1] 29015 0
2011 - Potts Point
Recruitment postcode(s) [2] 29016 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 284765 0
Commercial sector/Industry
Name [1] 284765 0
Inertial Orthopaedic Navigation Solutions
Country [1] 284765 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Inertial Orthopaedic Navigation Solutions
Address
c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 283655 0
None
Name [1] 283655 0
Address [1] 283655 0
Country [1] 283655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305101 0
Bellberry
Ethics committee address [1] 305101 0
123 Glen Osmond Rd,
Eastwood SA 5063
Ethics committee country [1] 305101 0
Australia
Date submitted for ethics approval [1] 305101 0
09/03/2011
Approval date [1] 305101 0
11/04/2011
Ethics approval number [1] 305101 0
2011-02-073

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33821 0
Prof Lawrence Kohan
Address 33821 0
Joint Orthopaedic Centre, Suite 301C, 9-13 Bronte Road, Bondi Junction, 2022, NSW
Country 33821 0
Australia
Phone 33821 0
+61 2 9387 2877
Fax 33821 0
Email 33821 0
[email protected]
Contact person for public queries
Name 17068 0
Bob Lye
Address 17068 0
c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
Country 17068 0
Australia
Phone 17068 0
+61 2 9939 0900
Fax 17068 0
Email 17068 0
[email protected]
Contact person for scientific queries
Name 7996 0
Bob Lye
Address 7996 0
c/o William Buck NSW Pty Ltd
Level 29, 66 Goulburn Street
Sydney, NSW, 2000
Country 7996 0
Australia
Phone 7996 0
+61 2 9939 0900
Fax 7996 0
Email 7996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial abandoned


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.