Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000845538
Ethics application status
Approved
Date submitted
21/07/2015
Date registered
14/08/2015
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised control trial of less Invasive Piriformis sparing Hip Approach: 10 year Follow-up
Scientific title
Randomised control trial of less Invasive Piriformis sparing Hip Approach: 10 year Follow-up
Secondary ID [1] 287088 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty 295597 0
Condition category
Condition code
Surgery 295875 295875 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
10 year follow-up of patient that underwent piriformis sparing approach compared to standard posterior approach as described in A comparison of a less invasive piriformis-sparing approach versus the standard posterior approach to the hip, A randomised Control Trial. Khan, Maor, Hofmann and Haebich, The Journal of Bone & Joint Surgery. 94 B (1) jan 2012.
Intervention code [1] 292329 0
Not applicable
Comparator / control treatment
standard posterior approach for total hip arthroplasty
Control group
Active

Outcomes
Primary outcome [1] 295630 0
Functional disability assessed using the Oxford Hip Score
Timepoint [1] 295630 0
10 year
Primary outcome [2] 295631 0
Short Form 12
Timepoint [2] 295631 0
10 year
Primary outcome [3] 295633 0
ability and endurance to mobilise is assessed 6 minute walk test
Timepoint [3] 295633 0
10 year
Secondary outcome [1] 316046 0
Subjective personal health concerns and complications will be assessed using a general health questionnaire
Timepoint [1] 316046 0
10 year

Eligibility
Key inclusion criteria
Patients previously recruited for A comparison of a less invasive piriformis-sparing approach versus the standard posterior approach to the hip, A randomised Control Trial. Khan, Maor, Hofmann and Haebich, The Journal of Bone & Joint Surgery. 94 B (1) jan 2012.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
revision surgery on the included hip

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Population is based on previous trial: A comparison of a less invasive piriformis-sparing approach versus the standard posterior approach to the hip, A randomised Control Trial. Khan, Maor, Hofmann and Haebich, The Journal of Bone & Joint Surgery. 94 B (1) jan 2012.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
1/06/2017
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
80
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4076 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 291690 0
Self funded/Unfunded
Name [1] 291690 0
Country [1] 291690 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 290365 0
None
Name [1] 290365 0
Address [1] 290365 0
Country [1] 290365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293217 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 293217 0
Hospital Ave, Nedlands WA 6009
Ethics committee country [1] 293217 0
Australia
Date submitted for ethics approval [1] 293217 0
26/07/2015
Approval date [1] 293217 0
20/11/2015
Ethics approval number [1] 293217 0
HREC No: 2015-125

Summary
Brief summary
To assess the long term quality of the tendon, it’s isometric strength and the clinical outcomes of a piriformis sparing approach to total hip arthroplasty as compared to a standard posterior approach. A randomised, controlled cohort of 100 patients previously followed to the 5 year period will be assessed at 10 year follow-up with clinical scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58786 0
Dr Craig Brownlie
Address 58786 0
Sir Charles Gairdner Hospital,
Hospital Ave, Nedlands
WA 6009
Country 58786 0
Australia
Phone 58786 0
+61417793837
Fax 58786 0
Email 58786 0
brownliecraig@hotmail.com
Contact person for public queries
Name 58787 0
Ms Sam Haebich
Address 58787 0
The Joint Studio
Suite 1, 85 Monash Avenue
Hollywood Medical Centre
Nedlands, Western Australia 6009
Country 58787 0
Australia
Phone 58787 0
+61417793837
Fax 58787 0
Email 58787 0
brownliecraig@hotmail.com
Contact person for scientific queries
Name 58788 0
Dr Craig Brownlie
Address 58788 0
Sir Charles Gairdner Hospital,
Hospital Ave, Nedlands
WA 6009
Country 58788 0
Australia
Phone 58788 0
+61417793837
Fax 58788 0
Email 58788 0
brownliecraig@hotmail.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.