Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000961246
Ethics application status
Approved
Date submitted
5/11/2009
Date registered
6/11/2009
Date last updated
6/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) assessment of the short external rotators post total hip replacement – a randomized trial
Scientific title
A randomized trial comparing capsulotendinous repair post-surgery in piriformis-sacrificing approach with piriformis-sparing approach in patients undergoing total hip arthroplasty.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 252133 0
Rheumatoid arthritis 252134 0
Condition category
Condition code
Inflammatory and Immune System 252340 252340 0 0
Rheumatoid arthritis
Musculoskeletal 252343 252343 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo total hip arthroplasty without the piriformis muscle being incised. This will take 1-2 hours.
Intervention code [1] 241511 0
Treatment: Surgery
Comparator / control treatment
Patients will undergo total hip arthroplasty with the piriformis muscle being incised and then repaired at the end. This will take 1-2 hours.
Control group
Active

Outcomes
Primary outcome [1] 253212 0
Muscle quality will be graded according to the degree of fatty atrophy using a Magnetic Resonance Imaging (MRI) Scan.
Timepoint [1] 253212 0
12 weeks post-surgery
Secondary outcome [1] 262143 0
Muscle bulk will be measured using commercial 3-dimensional image analysis software. The bulk of each muscle of interest will be analysed by tracing around its border in each axial slice of the Magnetic Resonance Imaging (MRI). This 2-dimensional data will then be converted into a volume calculation by the software program.
Timepoint [1] 262143 0
12 weeks post-surgery

Eligibility
Key inclusion criteria
Patients undergoing total hip arthroplasty
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are claustrophobia and fixed external rotation contractures.

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
Recruiting
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243983 0
Self funded/Unfunded
Name [1] 243983 0
Country [1] 243983 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 251335 0
None
Name [1] 251335 0
Address [1] 251335 0
Country [1] 251335 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244090 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 244090 0
Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 244090 0
Australia
Date submitted for ethics approval [1] 244090 0
Approval date [1] 244090 0
Ethics approval number [1] 244090 0

Summary
Brief summary
The purpose of this study is to compare two surgical approaches to see which has the best muscle healing post-operatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30471 0
Address 30471 0
Country 30471 0
Phone 30471 0
Fax 30471 0
Email 30471 0
Contact person for public queries
Name 13718 0
Riaz Khan
Address 13718 0
Hospital Avenue
Nedlands
WA 6009
Country 13718 0
Australia
Phone 13718 0
+618 93461499
Fax 13718 0
Email 13718 0
tibialalignment@gmail.com
Contact person for scientific queries
Name 4646 0
Riaz Khan
Address 4646 0
Hospital Avenue
Nedlands
WA 6009
Country 4646 0
Australia
Phone 4646 0
+618 93461499
Fax 4646 0
Email 4646 0
tibialalignment@gmail.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.