Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000954921
Ethics application status
Approved
Date submitted
24/08/2011
Date registered
5/09/2011
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, non-randomized Roentgen Stereophotogrammetric Analysis study of the Stryker Accolade II(R) Hip Stem
Scientific title
A prospective, non-randomized Roentgen Stereophotogrammetric Analysis study to determine the migration pattern of the Stryker Accolade II(R) Hip Stem in patients undergoing total hip arthroplasty
Secondary ID [1] 262911 0
'Nil known
Universal Trial Number (UTN)
U1111-1123-9717
Trial acronym
AccoladeRSA-11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the hip 270637 0
Condition category
Condition code
Musculoskeletal 270810 270810 0 0
Osteoarthritis
Surgery 270893 270893 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Candidates in the study will be selected from a
pool of patients undergoing total hip replacement. In order to evaluate the Accolade II femoral hip stem radiopaue tantalum bead markers will be inserted resulting in the standard operating time (typically 1-2 hours) being extended by approximately 10 minutes.
Intervention code [1] 269261 0
Treatment: Surgery
Intervention code [2] 269335 0
Treatment: Devices
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279505 0
To determine the migration pattern (translations and rotations) of the Accolade II(R) stem during the first 2 years post-surgery. This will be assessed via measurement on x-rays of any micromotion of tantalum bead markers that were inserted at the time of surgery.
Timepoint [1] 279505 0
Pre-operative
Intra-operative
Post-Operative - 3 months
Post-Operative - 6 months
Post-operative - 12 months
Post-operative - 24 months
Secondary outcome [1] 287765 0
To compare radiographic findings before and after total hip arthroplasty using the cementless Accolade II(R) total hip arthroplasty components.
Timepoint [1] 287765 0
Pre-operative
Intra-operative
Post-Operative - 3 months
Post-Operative - 6 months
Post-operative - 12 months
Post-operative - 24 months
Secondary outcome [2] 287927 0
To compare pain before and after total hip arthroplasty using the cementless Accolade II(R) total hip arthroplasty components. The WOMAC, EuroQol EQ-5D and Vas pain questionnaires will be used to assess this outcome.
Timepoint [2] 287927 0
Pre-operative
Intra-operative
Post-Operative - 3 months
Post-Operative - 6 months
Post-operative - 12 months
Post-operative - 24 months
Secondary outcome [3] 287928 0
To compare function before and after total hip arthroplasty using the cementless Accolade II(R) total hip arthroplasty components. The WOMAC and EuroQol EQ-5D questionnaires will be used to assess this outcome.
Timepoint [3] 287928 0
Pre-operative
Intra-operative
Post-Operative - 3 months
Post-Operative - 6 months
Post-operative - 12 months
Post-operative - 24 months
Secondary outcome [4] 287929 0
To compare health-related quality of life (QOL) before and after total hip arthroplasty using the cementless Accolade II(R) total hip arthroplasty components. The WOMAC and EuroQol EQ-5D questionnaires will be used to assess this outcome.
Timepoint [4] 287929 0
Pre-operative
Intra-operative
Post-Operative - 3 months
Post-Operative - 6 months
Post-operative - 12 months
Post-operative - 24 months

Eligibility
Key inclusion criteria
1. The patient is a male or non-pregnant female between the ages of 20-80.
2. The patient is a candidate for a primary cementless total hip replacement using the study devices.
3. The patient has a primary diagnosis of non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
4. The patient has signed the study specific, HREC-approved, Informed Consent document.
5. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with active infection within the affected hip joint.
2. Patients requiring revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. The patient is obese (BMI >= 40).
4. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
5. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
6. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
7. Patient has a cognitive impairment, an intellectual disability or a mental illness.
8. The patient is pregnant.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
24/05/2012
Date of last participant enrolment
Anticipated
Actual
13/02/2014
Date of last data collection
Anticipated
Actual
25/02/2016
Sample size
Target
35
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269728 0
Commercial sector/Industry
Name [1] 269728 0
Stryker Australia
Country [1] 269728 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia
Address
8 Herbert St
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 268768 0
None
Name [1] 268768 0
Address [1] 268768 0
Country [1] 268768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271696 0
Royal Perth HREC
Ethics committee address [1] 271696 0
Royal Perth Hospital
Colonial House
Murray Street
Perth WA 6000
Ethics committee country [1] 271696 0
Australia
Date submitted for ethics approval [1] 271696 0
Approval date [1] 271696 0
27/05/2011
Ethics approval number [1] 271696 0
EC 2011/065
Ethics committee name [2] 296646 0
St John of God Ethics Committee
Ethics committee address [2] 296646 0
12 Salvado Road, Subiaco WA
Ethics committee country [2] 296646 0
Australia
Date submitted for ethics approval [2] 296646 0
31/10/2012
Approval date [2] 296646 0
07/05/2013
Ethics approval number [2] 296646 0
580

Summary
Brief summary
This study aims to identify whether there is a difference in the micromotion of the Accolade II(R) cementless femoral stem between 6 months post-surgery and 2 years post-surgery, providing an indication of long-term fixation. Functional outcomes, pain and quality of life will also be assessed. This study is a prospective observational case series being performed at a single study centre. One Principle Investigator will perform all surgery for this study.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33070 0
Dr N/A
Address 33070 0
Perth Hip & Knee
Suite 1/1 Wexford Street,
Subiaco WA 6008
Country 33070 0
Australia
Phone 33070 0
N/A
Fax 33070 0
Email 33070 0
N/A
Contact person for public queries
Name 16317 0
Mrs Natascha Millard
Address 16317 0
Quality and Clinical Research Manager 8 Herbert St Leonards NSW 2065
Country 16317 0
Australia
Phone 16317 0
+61 2 9467 1073
Fax 16317 0
Email 16317 0
[email protected]
Contact person for scientific queries
Name 7245 0
Mrs Natascha Millard
Address 7245 0
Quality and Clinical Research Manager 8 Herbert St Leonards NSW 2065
Country 7245 0
Australia
Phone 7245 0
+61 2 9467 1073
Fax 7245 0
Email 7245 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.