Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001030268
Ethics application status
Approved
Date submitted
23/11/2009
Date registered
27/11/2009
Date last updated
29/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, observational case series to assess the clinical utility of improved methods of functional hip navigation for total hip replacement
Scientific title
In patients undergoing computer-assisted total hip replacement surgery, can a graphical user interface be used to display the functional hip range of motion for assessment of impingement.
Secondary ID [1] 1154 0
None
Universal Trial Number (UTN)
U1111-1112-5985
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 252256 0
Rheumatoid arthritis 252300 0
Avascular necrosis 252301 0
Condition category
Condition code
Musculoskeletal 252445 252445 0 0
Osteoarthritis
Musculoskeletal 252483 252483 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Candidates in the study will be selected from a pool of patients undergoing total hip replacement using computer assisted surgery as standard of care. Additional observations will be made during the procedure resulting in the standard operating time (typically 1-2 hours) being extended by approximately 10 minutes. Patients will only be observed during the joint replacement surgery with no post-operative follow-ups included. The total duration of this observation study will be 12 months including patient recruitment.
Intervention code [1] 241587 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253317 0
Intra-operative functional hip range of motion will be measured by the computer-assisted surgery system before hip dislocation and after total hip replacement.
Timepoint [1] 253317 0
Intra-operative
Secondary outcome [1] 262390 0
None
Timepoint [1] 262390 0
Not applicable

Eligibility
Key inclusion criteria
1. Patient is a candidate for primary total hip replacement using computer navigation.
2. Patient has a primary diagnosis of osteoarthritis, rheumatoid arthritis or avascular necrosis.
3. Patient is a male or non-pregnant female patient age 18 to 90.
4. Patient has signed a Human Research Ethics Committee (HREC)-approved, study specific Information Patient Consent Form.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has abnormal pelvic anatomy (previous fracture, osteotomy or development dysplasia).
2. Patient is morbidly obese (Body Mass Index, BMI >= 40).
3. Patient has an existing condition where increasing surgical time may be detrimental to the patient.
4. Patient has a cognitive impairment, an intellectual disability or a mental illness.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2260 0
2131
Recruitment postcode(s) [2] 2259 0
3084
Recruitment postcode(s) [3] 2258 0
4032

Funding & Sponsors
Funding source category [1] 244069 0
Commercial sector/Industry
Name [1] 244069 0
Stryker Australia
Country [1] 244069 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia
Address
8 Herbert Street
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 251415 0
None
Name [1] 251415 0
Address [1] 251415 0
Country [1] 251415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258168 0
The Prince Charles Hospital HREC
Ethics committee address [1] 258168 0
Building 12,
The Prince Charles Hospital,
Rode Road
CHERMSIDE QLD 4122
Ethics committee country [1] 258168 0
Australia
Date submitted for ethics approval [1] 258168 0
26/11/2009
Approval date [1] 258168 0
14/12/2009
Ethics approval number [1] 258168 0
HREC/09/QPCH/194
Ethics committee name [2] 260104 0
St Vincent's and Holy Spirit Health HREC
Ethics committee address [2] 260104 0
Group Services & Support Office, 48 Montpelier Road, BOWEN HILLS QLD 4006
Ethics committee country [2] 260104 0
Australia
Date submitted for ethics approval [2] 260104 0
24/08/2010
Approval date [2] 260104 0
03/09/2010
Ethics approval number [2] 260104 0
HREC #10/09
Ethics committee name [3] 272087 0
Sydney South West Area Health Service HREC - CRGH
Ethics committee address [3] 272087 0
Concord Repatriation General Hospital
CONCORD NSW 2139
Ethics committee country [3] 272087 0
Australia
Date submitted for ethics approval [3] 272087 0
14/08/2010
Approval date [3] 272087 0
06/12/2010
Ethics approval number [3] 272087 0
CH62/6/2010-104

Summary
Brief summary
This is an observational study to assess the clinical utility of new methods of displaying information collected during computer-assisted primary total hip replacement surgery used to treat patients with osteoarthritis. The position of the leg will be displayed, measured and recorded at various stages in the procedure. This information will be used to decide upon future improvements in software with the aim of providing surgeons with better guidance on the optimal position of hip replacement components.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30539 0
Address 30539 0
Country 30539 0
Phone 30539 0
Fax 30539 0
Email 30539 0
Contact person for public queries
Name 13786 0
Dr Timothy Barker
Address 13786 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
St Leonards NSW 2065
Country 13786 0
Australia
Phone 13786 0
+61 7 3840 5200
Fax 13786 0
Email 13786 0
tim.barker@stryker.com
Contact person for scientific queries
Name 4714 0
Dr Timothy Barker
Address 4714 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
St Leonards NSW 2065
Country 4714 0
Australia
Phone 4714 0
+61 7 3840 5200
Fax 4714 0
Email 4714 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
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