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Trial registered on ANZCTR


Registration number
ACTRN12609000932268
Ethics application status
Not yet submitted
Date submitted
23/09/2009
Date registered
29/10/2009
Date last updated
17/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of of partially coated or completely coated hip replacement stems for patients with osteoarthritis
Scientific title
A prospective, multicenter, randomized migration study of the Anthology cementless femoral stem in patients with degenerative hip disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip osteoarthritis 251913 0
Condition category
Condition code
Musculoskeletal 252090 252090 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
prospective controlled trial comparing partially coated cementless stem to fully hydroxyapatite (HA) coated cementless stem.

cementless stems utilise a fixation surface to optimise the fixation to bone. In this design the proximal end of the stem has a macro texture with a titanium coating. Hydroxyapatite is applied to the proximal coating or the full length of the stem to enhance initial fixation.

Patients enrolled in this study will have their surgery during a 12 month
recruitment period. The operation takes approximately 1 hour. Patients will be studied for two years following their surgery and will return for routine follow-up thereafter.
Intervention code [1] 241334 0
Treatment: Surgery
Comparator / control treatment
partially HA-coated compared it to fully-HA coated femoral component

cementless stems utilise a fixation surface to optimise the fixation to bone. In this design the proximal end of the stem has a macro texture with a titanium coating. Hydroxyapatite is applied to the proximal coating or the full length of the stem to enhance initial fixation.

Patients enrolled in this study will have their surgery during a 12 month
recruitment period. The operation takes approximately 1 hour. Patients will be studied for two years following their surgery and will return for routine follow-up thereafter.
Control group
Active

Outcomes
Primary outcome [1] 252971 0
femoral component migration.

Initial migrations of femoral component has been shown to be a reliable predictor of long-term performance. Radiostereometric analysis (RSA) is a validated and and precise method to determine implant performance. It is recommended that new implants or design changes be analysed by RSA to predict their long-term outcome.
Timepoint [1] 252971 0
two years from baseline
Secondary outcome [1] 257722 0
clinical outcomes patient assessment scores including Oxford hip scores and the Hip dysfunction and Osteoarthritis Outcome Score (HOOS score). These are validated self-assessment call for the use of hip osteoarthritis. Patients will complete self-assessment before the surgery, at one year and two years following surgery.
Timepoint [1] 257722 0
Patients will have clinical scores collected preoperatively, one year,and two years following surgery. Radigraphs will be taken in the first post-operative week, six weeks, three months, one year and two years following the surgery.

Eligibility
Key inclusion criteria
hip osteoarthritis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non-osteoarthritis hip disease

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)
Patients who are booked for hip replacement surgery and have been selected to have a cementless femoral component by the surgeon will be invited by an independent research nurse to enter the study.

Treatment allocation concealed; research nurse will use random number generation and sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generation by permuted block randomisation.
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
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243781 0
Commercial sector/Industry
Name [1] 243781 0
Smith and nephew
Country [1] 243781 0
Australia
Primary sponsor type
Individual
Name
David Campbell
Address
Wakefield orthopaedic clinic
270Wakefield Street
South Australia
Adelaide 5000
Country
Australia
Secondary sponsor category [1] 237136 0
Individual
Name [1] 237136 0
professor Warwick Bruce
Address [1] 237136 0
47- 49 Burwood Road
Concord NSW 2137
Australia
Country [1] 237136 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243912 0
Calvary Wakefield Hospital
Ethics committee address [1] 243912 0
250 Wakefield St
South Australia
Adelaide 5000
Ethics committee country [1] 243912 0
Australia
Date submitted for ethics approval [1] 243912 0
01/10/2009
Approval date [1] 243912 0
Ethics approval number [1] 243912 0

Summary
Brief summary
The purpose of this clinical study is to determine the predicted long-term safety and effectiveness of the anthology cementless femoral stem using an RSA technique to yield early results in small numbers of patients. The secondary purpose of this study is to assess the efficacy of fully coating this stem with hydroxyapatite (HA) compared to a proximally-HA coated stem.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 30324 0
Address 30324 0
Country 30324 0
Phone 30324 0
Fax 30324 0
Email 30324 0
Contact person for public queries
Name 13571 0
David Campbell
Address 13571 0
Wakefield orthopaedic clinic
270 Wakefield Street
South Australia
Adelaide 5000
Country 13571 0
Australia
Phone 13571 0
+61 8 8236-4196
Fax 13571 0
Email 13571 0
n/a
Contact person for scientific queries
Name 4499 0
David Campbell
Address 4499 0
Wakefield orthopaedic clinic
270 Wakefield Street
South Australia
Adelaide 5000
Country 4499 0
Australia
Phone 4499 0
+61 8 82364196
Fax 4499 0
Email 4499 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.