Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000064808
Ethics application status
Not yet submitted
Date submitted
11/01/2012
Date registered
12/01/2012
Date last updated
12/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the rotational stability of a tapered stem component of a total hip replacement
Scientific title
Radiostereometric assessment of the rotational stability of Collarless Polished Tapered (CPT) stems inserted for primary hip arthroplasty
Secondary ID [1] 279714 0
Nil
Universal Trial Number (UTN)
U1111-1127-0753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip arthritis 285547 0
Condition category
Condition code
Musculoskeletal 285740 285740 0 0
Osteoarthritis
Surgery 285748 285748 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total hip arthroplasty utilising CPT stem (as is investigators routine practice for hip arthritis) The collarless polished tapered (CPT) stem is the 3rd most commonly inserted femoral component in Australia for total hip arthroplasty. It is a cemented stem. Total hip arthroplasty with a CPT component usually takes between 1 hour and 90 mins,
Rotational stability of the stem will be assessed by RSA.
Intervention code [1] 284012 0
Treatment: Devices
Intervention code [2] 284016 0
Treatment: Surgery
Comparator / control treatment
Historical data on the Exeter stem and Charnley elite stem (Glyn-Jones et al, JBJS 2005), and the C-stem (Sundberg et al JBJS 2005)
Control group
Historical

Outcomes
Primary outcome [1] 286266 0
Rotational movement of CPT stem within cement mantle. This will be assessed by Radiostereometric assessment (RSA).
Timepoint [1] 286266 0
Post-operatively, 6 weeks, 3 months, 12 months, 24 months
Secondary outcome [1] 295470 0
Change in stem alignment into varus/valgus. This will be assessed by Radiostereometric assessment (RSA).
Timepoint [1] 295470 0
Post-operatively, 6 weeks, 3 months, 12 months, 24 months

Eligibility
Key inclusion criteria
Patients with primary hip arthritis
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous proximal femoral surgery
AVN
Proximal femoral deformity
Previous fracture

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Anyone elligible for total hip arthroplasty will be eligible to participate. The surgical treatment (CPT total hip replacement) is not being altered by participation in the trial.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284496 0
Hospital
Name [1] 284496 0
Fremantle Hospital
Country [1] 284496 0
Australia
Primary sponsor type
Individual
Name
Professor Piers Yates
Address
Orthopaedic Department
Fremantle Hospital
PO Box 480
Fremantle
Perth
WA 6959
Country
Australia
Secondary sponsor category [1] 283425 0
None
Name [1] 283425 0
Address [1] 283425 0
Country [1] 283425 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286475 0
Ethics committee address [1] 286475 0
Ethics committee country [1] 286475 0
Date submitted for ethics approval [1] 286475 0
17/01/2012
Approval date [1] 286475 0
Ethics approval number [1] 286475 0

Summary
Brief summary
To see if the broader lateral shoulder of the CPT stem affords more rotational stability than that recorded for other polished tapered stems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33621 0
Address 33621 0
Country 33621 0
Phone 33621 0
Fax 33621 0
Email 33621 0
Contact person for public queries
Name 16868 0
Professor Piers Yates
Address 16868 0
Orthopaedic Department
Fremantle Hospital
PO Box 480
Fremantle
Perth
WA 6959
Country 16868 0
Australia
Phone 16868 0
+61 08 9312 1135
Fax 16868 0
Email 16868 0
[email protected]
Contact person for scientific queries
Name 7796 0
Professor Piers Yates
Address 7796 0
Orthopaedic Department
Fremantle Hospital
PO Box 480
Fremantle
Perth
WA 6959
Country 7796 0
Australia
Phone 7796 0
+61 08 9312 1135
Fax 7796 0
Email 7796 0
[email protected]

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.