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Trial registered on ANZCTR


Trial ID
ACTRN12613000629730
Ethics application status
Approved
Date submitted
14/05/2013
Date registered
3/06/2013
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, multi-centre randomised comparative study of
implant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem
Scientific title
A prospective, multi-centre randomised comparative study of
implant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem
Secondary ID [1] 282500 0
Nil known
Universal Trial Number (UTN)
U1111-1143-0732
Trial acronym
Accolade II-12
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement Surgery 289154 0
Non-Inflammatory Degenerative Joint Disease of the Hip 289155 0
Condition category
Condition code
Musculoskeletal 289626 289626 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to this group will recieve an Accolade II Hip Stem. Duration of surgery is approximately 1.5hours.
Intervention code [1] 287152 0
Treatment: Surgery
Intervention code [2] 287153 0
Treatment: Devices
Comparator / control treatment
Patients randomised to this group will recieve a Depuy Corail Hip Stem. Duration of surgery is approximately 1.5hours.A second comparator the Anato hip stem will be investigated in the NZ substudy. Patients randomised to this group will receive an Anato hip stem. Duration of surgery is approximately 1.5 hours.
Control group
Active

Outcomes
Primary outcome [1] 289583 0
1. To compare the pre-operative plan with the intraoperative size preferance of femoral stem in patients randomised to either Accolade II or Corail femoral stem.
Radiolographs and surgical data
Timepoint [1] 289583 0
Pre-Operative, Intra-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Primary outcome [2] 289584 0
2. To determine clinical outcomes of THR, using the Oxford Hip Score, in patients receiving the Accolade II femoral stem compared to Corail femoral stem
Timepoint [2] 289584 0
Pre-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Primary outcome [3] 295613 0
NZ iDXA/Anato stem substudy primary outcome: To compare the % differences in pre-operative (BMD) over time, in the regions of interest (ROIs) based on the Gruen zones, around the Accolade II, Corail or Anato stems. This percent change in BMD will be measured using an iDXA machine.
Timepoint [3] 295613 0
Pre-op, 6 week, 12 mnth, 24 mth
Secondary outcome [1] 302772 0
1. To determine the femoral canal fit of Accolade II femoral stem compared to the Corail femoral stem, looking at metaphseal, diaphyseal or combined engagement of the stem during the first two years postoperatively.
Radiographs
Timepoint [1] 302772 0
Pre-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Secondary outcome [2] 302774 0
2. To further determine clinical outcomes of THR (including pain, function and health related quality of life) with
Accolade II femoral stem compared to Corail femoral stem via: EQ5D a standardised instrument for use as a measure of health outcome, and VAS Pain scale.
Timepoint [2] 302774 0
Pre-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Secondary outcome [3] 302775 0
3. To determine patient satisfaction with THR experience and compare satisfaction with Accolade II femoral stem, v.Corail femoral stem. Likert scale
Timepoint [3] 302775 0
Post - Operative - 6 weeks, 6 months, 12 months, 24 months
Secondary outcome [4] 302776 0
4. To determine surgeon satisfaction with use of the Accolade II femoral stem compared to use of the Corail femoral stem. Likert Scale
Timepoint [4] 302776 0
Intra-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Secondary outcome [5] 302777 0
5. To compare incidence of loosening, thigh pain, reoperation and revision in patients receiving Accolade II femoral stem compared to Corail femoral stem.
Medical/Surgical Data, Radiography.
Timepoint [5] 302777 0
Intra-Operative, Post - Operative - 6 weeks
6 months, 12 months, 24 months
Secondary outcome [6] 302778 0
6. To determine length of hospital stay in patient receiving Accolade II femoral stem, compared to Corail femoral stem.
Timepoint [6] 302778 0
Intra-Operative
Secondary outcome [7] 303093 0
In a subgroup: to determine if serum metal ion levels are increased following implant with Accolade II femoral stem compared to Corail femoral stem.
Pathology
Timepoint [7] 303093 0
Pre-operative, 6 months, 12 months, 24 months post-operatively
Secondary outcome [8] 315986 0
(NZ iDXA/Anato stem substudy ONLY): HAAS High activity arthroplasty score
Timepoint [8] 315986 0
Pre-Op, 6 week, 6 mth, 12mth, 24 mth

Eligibility
Key inclusion criteria
1.Patient are male or non-pregnant females requiring a cementless THR for non-inflammatory degenerative joint disease of the hip.
2.Must be older than 18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a cognitive impairment, an intellectual disability or a mental illness
2. People whose primary language is other than English
3. Pregnant Women
4. Children and or/young people (ie. <18 years)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Phase 4
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)
QLD,WA,VIC
Recruitment outside Australia
Country [1] 7040 0
New Zealand
State/province [1] 7040 0
Cantebury

Funding & Sponsors
Funding source category [1] 287282 0
Commercial sector/Industry
Name [1] 287282 0
Stryker Australia Pty Ltd
Address [1] 287282 0
8 Herbert Street
St Leonards
NSW 2065
Country [1] 287282 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd
Address
8 Herbert Street
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 286036 0
None
Name [1] 286036 0
Address [1] 286036 0
Country [1] 286036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297370 0
Southern Health Ethics
Ethics committee address [1] 297370 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 297370 0
Australia
Date submitted for ethics approval [1] 297370 0
23/11/2012
Approval date [1] 297370 0
20/02/2013
Ethics approval number [1] 297370 0
HREC/12/SHB/19
Ethics committee name [2] 297371 0
Monash Health
Ethics committee address [2] 297371 0
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [2] 297371 0
Australia
Date submitted for ethics approval [2] 297371 0
11/11/2014
Approval date [2] 297371 0
23/01/2015
Ethics approval number [2] 297371 0
HREC/12/SHB/19
Ethics committee name [3] 297372 0
South Metropolitan Health Service
Ethics committee address [3] 297372 0
Research Ethics and Governance Unit
South Metropolitan Health Service
Level 3 Perkins South Building,
Fiona Stanley Hospital Campus
Locked Bag 100, PALMYRA DC WA 6961
Ethics committee country [3] 297372 0
Australia
Date submitted for ethics approval [3] 297372 0
11/12/2012
Approval date [3] 297372 0
14/03/2013
Ethics approval number [3] 297372 0
13/2
Ethics committee name [4] 297373 0
Southern Health and Disability Ethics Committee
Ethics committee address [4] 297373 0
C/- Medsafe, level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
Ethics committee country [4] 297373 0
New Zealand
Date submitted for ethics approval [4] 297373 0
25/02/2014
Approval date [4] 297373 0
06/03/2014
Ethics approval number [4] 297373 0
12/STH/56/AM02

Summary
Brief summary
This study is a prospective, multi-centre, randomised clinical study comparing the preoperative radiographic plan to the intra-operative femoral stem sizing, and assessing post-operative fit, clinical and satisfaction outcomes. The study will be conducted in patients with Non-inflammatory Degenerative Joint Disease. In addition, a substudy is running in NZ to evaluate the differences in peri-prosthetic bone remodelling post hip replacement in 3 different femoral component implants. The Lunar iDXA (GE Healthcare, Madison, WI) densitometer is a Food and Drug Administration (FDA) - approved device for measuring BMD and body composition. The relationship between bone loss, patient functional outcome and implant survival across the 3 femoral stems will also be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40038 0
Dr Ton Tran
Address 40038 0
Dandenong Hospital
David Street
Dandenong VIC 3175
Country 40038 0
Australia
Phone 40038 0
+61 3 9554 8945
Fax 40038 0
Email 40038 0
Ton.Tran@monashhealth.org
Contact person for public queries
Name 40039 0
Mrs Natascha Millard
Address 40039 0
Stryker
8 Herbert Street
St Leonards
NSW 2065
Country 40039 0
Australia
Phone 40039 0
+61 2 9467 1073
Fax 40039 0
Email 40039 0
Natascha.Millard@stryker.com
Contact person for scientific queries
Name 40040 0
Mrs Natascha Millard
Address 40040 0
Stryker
8 Herbert Street
St Leonards
NSW 2065
Country 40040 0
Australia
Phone 40040 0
+61 2 9467 1073
Fax 40040 0
Email 40040 0
Natascha.Millard@stryker.com