Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001011875
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
19/09/2012
Date last updated
19/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ten Year Survivorship and Clinical Outcome of the Genesis II Prosthesis for Total Knee Replacement
Scientific title
Ten Year Survivorship and Clinical Outcome of the Genesis II Prosthesis for Total Knee Replacement
Secondary ID [1] 280819 0
Nil
Universal Trial Number (UTN)
U1111-1132-5674
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Outcome of Genesis II Total Knee Replacement prosthesis for the treatment of osteoarthritis of the knee 286887 0
Condition category
Condition code
Musculoskeletal 287205 287205 0 0
Osteoarthritis
Surgery 287795 287795 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clinical and Radiological outcome of Total Knee Replacement over 10 years
Intervention code [1] 285244 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287493 0
Survivorship of the total knee replacement as defined by the need for revision total knee replacement surgery confirmed at clinical review at 10 years
Timepoint [1] 287493 0
10 years
Secondary outcome [1] 298283 0
Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 298283 0
10 years
Secondary outcome [2] 298284 0
Radiological appearance
Timepoint [2] 298284 0
10 years

Eligibility
Key inclusion criteria
1.Primary Total knee replacement
2.Genesis II prosthesis
3.Patients willing to participate in a research program
4.No rheumatoid arthritis
5.Preop Fixed flexion deformity of < 15 degrees
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patients seeking compensation for their knee condition

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5531 0
2065

Funding & Sponsors
Funding source category [1] 285613 0
Commercial sector/Industry
Name [1] 285613 0
Smith & Nephew Surgical Pty Ltd
Country [1] 285613 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Leo Pinczewski
Address
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 284441 0
None
Name [1] 284441 0
Address [1] 284441 0
Country [1] 284441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287611 0
St Vincents HREC
Ethics committee address [1] 287611 0
Level 6, De Lacy Building
St Vincents Hospital
390 Victoria St
Darlinghurst NSW 2010
Ethics committee country [1] 287611 0
Australia
Date submitted for ethics approval [1] 287611 0
Approval date [1] 287611 0
22/08/2011
Ethics approval number [1] 287611 0
1/11/0088

Summary
Brief summary
This study examines survivorship and the clinical outcome in a series of 340 consecutive patients 10 years after TKR with the Genesis II prosthesis. All arthroplasties were performed by a single surgeon over a 3 year period.
Trial website
na
Trial related presentations / publications
na
Public notes

Contacts
Principal investigator
Name 34422 0
Address 34422 0
Country 34422 0
Phone 34422 0
Fax 34422 0
Email 34422 0
Contact person for public queries
Name 17669 0
Dr Lucy Salmon
Address 17669 0
North Sydney Orthopaedic and Sports Medicine Centre
The Mater Clinic
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 17669 0
Australia
Phone 17669 0
+612 9437 5999
Fax 17669 0
+612 9437 9595
Email 17669 0
[email protected]
Contact person for scientific queries
Name 8597 0
Associate Professsor Leo Pinczewski
Address 8597 0
North Sydney Orthopaedic and Sports Medicine Centre
The Mater Clinic
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 8597 0
Australia
Phone 8597 0
+612 9437 5999
Fax 8597 0
+612 9437 9595
Email 8597 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.