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Trial registered on ANZCTR


Registration number
ACTRN12608000234314
Ethics application status
Approved
Date submitted
5/05/2008
Date registered
7/05/2008
Date last updated
21/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
R3 Acetabular Hip system in patients with degenerative joint disease.
Scientific title
A prospective, multicenter, non-randomized study to evaluate the safety and efectiveness of the R3 Acetabular Hip System in patients with degenerative joint disease.
Secondary ID [1] 289710 0
Nil Known
Universal Trial Number (UTN)
U1111-1168-5231
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative joint disease. 3106 0
Condition category
Condition code
Musculoskeletal 3281 3281 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The R3 Acetabular System is designed with large ball heads providing increased range of motion and greater stability. This can significantly reduce the risk of hip dislocation, which is a crucial factor in the long term success of an implant. CoCr is an alloy of cobalt chrome with improved properties that make it suitable for use against ultra high molecular weight polyethylene surfaces in opposing friction couples.the length of the study is upto 5 years.
Intervention code [1] 2863 0
Treatment: Devices
Comparator / control treatment
n/a
Control group
Historical

Outcomes
Primary outcome [1] 4157 0
Safety will be measured by assessing all adverse events experienced by patients implanted with the study device.The incidence of surgery-related and device-related events such as device revision, component failure, malfunction, migration, subluxation, dislocation, loosening, nerve damage, deep infection, deep vein thrombosis, pulmonary embolism, or bone breakage/fracture will be collected.
Timepoint [1] 4157 0
Subjects will be seen at the 6 months, 1 year, 2 year, 3 year and 5 years interval post surgery.
Secondary outcome [1] 7000 0
Effectiveness will be measured using the Harris Hip Score, a patient self assessment questionnaire, and radiographic assessment.
Timepoint [1] 7000 0
Subjects will be seen at the 6 months, 1 year, 2 year, 3 year and 5 years interval

Eligibility
Key inclusion criteria
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/DDH).
3.Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk.
4 The patient will be available for follow-up throughout the duration of the study.
Minimum age
18 Years
Maximum age
N/A
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects 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
postoperative 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 or osteopenia)
5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
6.Patient has known moderate to severe renal insufficiency.
6.Patient has a known or suspected metal sensitivity.
7.Patient is immunosuppressed with diseases such as AIDS or receiving
high doses of corticosteroids.
8.Patient has an emotional or neurological condition that would pre-empt
their ability or unwillingness to participate in the study including mental
illness, mental retardation, or drug, alcohol abuse.
9.Patient is severely overweight.

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)
Non-Randomized, Unmasked, Consecutive series
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
N/A
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
ACT,SA
Recruitment hospital [1] 6195 0
The Canberra Hospital - Garran
Recruitment hospital [2] 6196 0
Wakefield Orthopaedic Clinic - Adelaide
Recruitment hospital [3] 6197 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 3362 0
Commercial sector/Industry
Name [1] 3362 0
Smith & Nephew
Address [1] 3362 0
85, Waterloo Road, North Ryde - 2113
Country [1] 3362 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew
Address
85, Waterloo Road, North Ryde - 2113
Country
Australia
Secondary sponsor category [1] 2997 0
None
Name [1] 2997 0
Address [1] 2997 0
Country [1] 2997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5378 0
Calvary Health Care Adelaide (CHCA)
Ethics committee address [1] 5378 0
300 Wakefield St
Adelaide SA 5000
Ethics committee country [1] 5378 0
Australia
Date submitted for ethics approval [1] 5378 0
08/05/2008
Approval date [1] 5378 0
25/02/2009
Ethics approval number [1] 5378 0

Summary
Brief summary
This study will investigate functional performance of the R3 Acetabular System, compared to a previous design, the Reflection System. Both systems are under approval by the Therapeutic Goods Administration, however the functional performance of the R3 Acetabular System compared to other systems has not yet been investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28564 0
Dr David Campbell
Address 28564 0
Wakefield Orthopaedic Clinic
270 Wakefield Street,
Adelaide SA 5000
Country 28564 0
Australia
Phone 28564 0
+61882364128
Fax 28564 0
Email 28564 0
hipknee@tpg.com.au
Contact person for public queries
Name 11721 0
Ms Kamla Raniga
Address 11721 0
85, Waterloo Road, North Ryde - 2113
Country 11721 0
Australia
Phone 11721 0
+61 2 9857 3999
Fax 11721 0
02 9857 3900
Email 11721 0
kamla.raniga@smith-nephew.com
Contact person for scientific queries
Name 2649 0
Ms Kamla Raniga
Address 2649 0
85, Waterloo Road, North Ryde - 2113
Country 2649 0
Australia
Phone 2649 0
+61 2 9857 3999
Fax 2649 0
02 9857 3900
Email 2649 0
kamla.raniga@smith-nephew.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary