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Trial registered on ANZCTR


Registration number
ACTRN12609000958280
Ethics application status
Approved
Date submitted
7/10/2009
Date registered
6/11/2009
Date last updated
6/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cluster Hole Versus Solid Cup Fixation in Total Hip Arthroplasty:
A Randomised Clinical Trial
Scientific title
A study to compare cluster hole and solid acetabular cups for lysis at five years following total hip arthroplasty in patients with osteoarthritis or rheumatoid arthritis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 251977 0
Rheumatoid arthritis 251978 0
Condition category
Condition code
Surgery 252167 252167 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient will undergo total hip arthroplasty. The acetabular component will be a cluster hole cup. The operation will take 1-2 hours.
Intervention code [1] 241387 0
Treatment: Surgery
Comparator / control treatment
Patient will undergo total hip arthroplasty. The acetabular component will be a solid cup. The operation will take 1-2 hours. .
Control group
Active

Outcomes
Primary outcome [1] 253042 0
Osteolysis. This will be measured with a computed tomography (CT) scan.
Timepoint [1] 253042 0
5 years post-surgery
Secondary outcome [1] 257854 0
Cup Migration. This will be measured with a computed tomography (CT) scan.
Timepoint [1] 257854 0
5 years post-surgery
Secondary outcome [2] 257855 0
Complications. These will include failure of prosthesis, infection, bleeding. This will be assessed at patient follow-up.
Timepoint [2] 257855 0
5 years post-surgery

Eligibility
Key inclusion criteria
Any patient requiring total hip arthroplasty for osteoarthritis or rheumatoid arthritis.
Minimum age
50 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Post-traumatic, dysplastic hip, shallow acetabulum.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent.
Randomisation concealed prior to enrollment with sealed opaque envelopes. Randomly assigned according to computer-generated list. Equal chance of being assigned to each arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 243852 0
Self funded/Unfunded
Name [1] 243852 0
Address [1] 243852 0
Country [1] 243852 0
Primary sponsor type
Individual
Name
Riaz Khan
Address
Sir Charles Gairdner Hospital
Orthopaedic Dept
Hospital Ave
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 237201 0
None
Name [1] 237201 0
Address [1] 237201 0
Country [1] 237201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243975 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 243975 0
Hospital Ave
Nedlands
WA 6009
Ethics committee country [1] 243975 0
Australia
Date submitted for ethics approval [1] 243975 0
Approval date [1] 243975 0
21/05/2009
Ethics approval number [1] 243975 0
2008-155

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30366 0
Address 30366 0
Country 30366 0
Phone 30366 0
Fax 30366 0
Email 30366 0
Contact person for public queries
Name 13613 0
Riaz Khan
Address 13613 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
WA 6009
Country 13613 0
Australia
Phone 13613 0
+618 93461499
Fax 13613 0
Email 13613 0
tibialalignment@gmail.com
Contact person for scientific queries
Name 4541 0
Riaz Khan
Address 4541 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
WA 6009
Country 4541 0
Australia
Phone 4541 0
+618 93461499
Fax 4541 0
Email 4541 0
tibialalignment@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results