Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000919011
Ethics application status
Approved
Date submitted
5/10/2010
Date registered
28/10/2010
Date last updated
27/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Radiostereometric Analysis (RSA) study of the Hyperion uncemented stem in patients with degenerative hip disease
Scientific title
A Radiostereometric Analysis (RSA) study of the Hyperion uncemented stem in patients with degenerative hip disease
Secondary ID [1] 252825 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative hip disease 258333 0
Condition category
Condition code
Musculoskeletal 258518 258518 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of the clinical study is to determine the predicted long-term safety and effectiveness of the Hyperion uncemented stem using Radiostereometric Analysis (RSA) to yield early results in small number of patients.
RSA is engaged to provide information to assess implant migration and can be used for early trials of new implant designs, potentially reducing the number of revisions by identifying new prosthesis that fail.
The medical device will be implanted using standard surgical technique, depending on the investigator’s standard procedure. Instrumentation specific for the device will be used. This is the only intervention for the patient and the intervention generally is completed within two hours.
Intervention code [1] 257347 0
Treatment: Devices
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259355 0
The primary objective of this study is to evaluate migration of the Hyperion
uncemented femoral stem in primary total hip replacement using Radiostereometric Analysis (RSA). RSA will be performed at discharge, 6 months, 1 year, 2 years and 5 years following surgery
Timepoint [1] 259355 0
Patients will be seen at the 6 month, 1 year, 2 and 5 year interval post surgery. The Oxford Hip Questionnaire12 and the Hip disability and osteoarthritis outcome score (HOOS)13 will be collected at the 1 year, 2 year and 5 year interval.

Radiographs will be taken postoperatively, and at 2 and 5 years following surgery. The following postoperative radiographs will be taken on all patients after implantation.

Anterior Posterior (AP)x ray of the pelvis and both hips (to include the entire prosthesis)
Lateral x ray of affected hip

Post operative radiographs will be evaluated by the Investigator to determine component alignment, lucencies, and bone condition. The alignment of the femoral prosthesis will be measured as the angle between the central axes of the proximal femoral canal and the femoral prosthesis. Angles will be classified as varus, valgus or neutral.







Evidence of radiographic failure is defined as any of the following:
Radioluciencies greater than 50 percent of the total bone prosthesis interface
Radiolucencies greater than 2 mm in greater than 2 zones
Subsidence or migration of any component greater than 5 mm


RSA assessments are completed at a follow-up of post-operative (discharge), 6 months, 1, 2, and 5 years.
Primary outcome [2] 259527 0
Radiographs will be assessed for evidence of any component failure that would result in device removal (e.g. breakage).
Timepoint [2] 259527 0
Radiographs will be taken postoperatively, and at 2 and 5 years following surgery.
Secondary outcome [1] 265836 0
The secondary objective of this study is to estimate the clinical and complication rates for the Hyperion uncemented femoral stem implant. Clinical evaluations will include the Oxford Hip Score, and the Hip Disability and Osteoarthritis Outcomes Score (HOOS), and an evaluation of any adverse events including clinical and radiological underperformance.
Information on surgery, operative site complications will be collected throughout the study at the 6 month, 1 year, 2 year and 5 year intervals. Outcomes using the Oxford Hip Score and the Hip Disability and Osteoarthritis Outcomes Score (HOOS), will be collected pre-operatively, 1 year, 2 years and 5 years following surgery.
Timepoint [1] 265836 0
Patients will be seen at the 6 month, 1 year, 2 and 5 year interval post surgery. The Oxford Hip Questionnaire and the Hip disability and osteoarthritis outcome score (HOOS) will be collected at the 1 year, 2 year and 5 year interval.

Eligibility
Key inclusion criteria
Patients must meet all of the following characteristics for inclusion in the study.

1. Patient is of legal age to consent and skeletally mature.

2. Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia or developmental dysplasia of the hip (DDH)) who are candidates for an uncemented femoral stem as determined jointly by the surgeon and patient.

3. Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk.

4. Patient who understands the conditions of the study and are willing and able to give written informed consent to participate in the length of the study and prescribed follow-ups.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any of the following characteristics must be excluded from participation in the study.

1. Patient has active infection or sepsis (treated or untreated).

2. Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery.

3. Patient is female of child-bearing age and not taking contraceptive precautions.

4. Patient has inadequate bone stock to support the device (e.g., severe osteopenia, family history of severe osteoporosis)

5. Patient has inflammatory joint disease (e.g., rheumatoid arthritis).

6. Patient has known moderate to severe renal insufficiency.

7. Patient has a known or suspected metal sensitivity.

8. Patient is immunosuppressed with diseases such as Aquired Immune Deficiency Syndrome (AIDS) or receiving high doses of corticosteroids.

9. Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, intellectual disability, or drug, alcohol abuse.


10. Patient is severely overweight. Body Mass Index ( BMI) > 40.

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)
The clinical investigator(s) or authorised delegate of the participating site will identify patients who meet the inclusion criteria. Patient enrolment is planned for an initial
period of approximately 12 months and will be performed as a consecutive case recruitment.
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
30/10/2010
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] 257800 0
Commercial sector/Industry
Name [1] 257800 0
Australian Orthopaedic Fixation Pty Ltd
Country [1] 257800 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Orthopaedic Fixation Pty Ltd
Address
18 Kinkaid Ave North Plympton SA 5037
Country
Australia
Secondary sponsor category [1] 257003 0
None
Name [1] 257003 0
Address [1] 257003 0
Country [1] 257003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259822 0
Southern Adelaide Health Service/Flinders University
Ethics committee address [1] 259822 0
Southern Adelaide Health Service/Flinders University
Flinders Clinical Research Ethics Committee, Room 2A 221 Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042.
Ethics committee country [1] 259822 0
Australia
Date submitted for ethics approval [1] 259822 0
Approval date [1] 259822 0
01/10/2010
Ethics approval number [1] 259822 0

Summary
Brief summary
The primary objective of this study is to evaluate migration of the Hyperion
uncemented femoral stem in primary total hip replacement using Radiostereometric Analysis (RSA). RSA will be performed at discharge, 6 months, 1 year, 2 years and 5 years following surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31739 0
Address 31739 0
Country 31739 0
Phone 31739 0
Fax 31739 0
Email 31739 0
Contact person for public queries
Name 14986 0
Adrian Blue
Address 14986 0
Austofix Pty Ltd 18 Kinkaid Ave North Plympton 5037
Country 14986 0
Australia
Phone 14986 0
+61(08)83510644
Fax 14986 0
Email 14986 0
adrian.blue@austofix.com.au
Contact person for scientific queries
Name 5914 0
Adrian Blue
Address 5914 0
Austofix Pty Ltd 18 Kinkaid Ave North Plympton 5037
Country 5914 0
Australia
Phone 5914 0
+61(08)83510644
Fax 5914 0
Email 5914 0
adrian.blue@austofix.com.au

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
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Documents added automatically
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