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Trial registered on ANZCTR


Registration number
ACTRN12611000289910
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
18/03/2011
Date last updated
18/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Anthropometric Evaluation of a New Asian Specific Knee Prosthesis - The Genesis II Slim
Scientific title
A multicentre, prospective, consecutive clinical study of the anthropometric dimensions of the Genesis II and Genesis II Slim Total Knee Prostheses in patients with degenerative joint disease requiring knee replacement.
Secondary ID [1] 259815 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory degenerative joint disease of predominantly the medial compartment requiring knee replacement. 265396 0
Condition category
Condition code
Musculoskeletal 265552 265552 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 – Part A compares the pre-cut heights and post-cut widths of the distal femur from patients of five different ethnicities to the known implant dimensions of the Genesis II and the modified Genesis II Slim femoral components across the available size range. Phase 1 - Part B evaluates the clinical outcome for a subset of patients from Phase 1 - Part A (Caucasian Australian, Chinese and Korean ethnicities). Following the acquisition of the measurements required to complete Part A of Phase 1 of the study, the Genesis II femoral component will be applied to the distal femur of these patients, and the amount of over/under hang measured. The amount of over/under hang will be compared with functional outcome over two years. Phase 2 – This phase evaluates the clinical outcome for the Genesis II Slim femoral component. Phase 1 will take 3 years, and Phase 2 will take another 3 years, for the total trial duration of 6 years.
Intervention code [1] 264245 0
Treatment: Devices
Comparator / control treatment
Comparator/control is the standard implant used in knee replacement: Genesis II.
Control group
Active

Outcomes
Primary outcome [1] 262358 0
Phase 1, part A: Anthropometric dimensions of the pre- and post-cut knee joint will be measured using measurement calipers.
Timepoint [1] 262358 0
Operative.
Secondary outcome [1] 273325 0
Phase 1, part B: The amount overhang or underhang at the will be measured using mesurement calipers following insertion of the distal femoral component of the Genesis II Total Knee System for patients of Caucasian Australian, Chinese and Korean ethnicity.
Timepoint [1] 273325 0
Operative.
Secondary outcome [2] 273326 0
The Knee Society Score (KSS) and levels of patient satisfaction will be recorded for each patient.
Timepoint [2] 273326 0
The Knee Society Score (KSS) will be recorded for each patient: preoperatively, and at 6 months, 1 year and 2 years postoperatively.
Levels of patient satisfaction will be recorded for each patient at 6 months, 1 year and 2 years postoperatively.
Secondary outcome [3] 273327 0
Radiographs taken will be scored according to the radiographic evaluation form to provide a measure of patellar tracking and adverse radiographic findings such as periprosthetic radiolucency, osteolysis or heterotopic ossification.
Timepoint [3] 273327 0
Preoperatively, at discharge and at 6 months, 1 year and 2 years postoperatively.
Secondary outcome [4] 273623 0
For the second phase of the study, the amount of over/under hang will be measured following insertion of the femoral component of the Genesis II Slim Total Knee System.
Timepoint [4] 273623 0
Operative.

Eligibility
Key inclusion criteria
Patient presents with non-inflammatory degenerative joint disease of predominantly the medial compartment requiring knee replacement.
Patient, or his/her legal guardian, has given consent to participate in the study.
Patient plans to be available for follow-up through to 2 years postoperative.
Minimum age
No limit
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient is known to have insufficient femoral or tibial bone stock.
Patient is immunosuppressed or has an autoimmune disorder.
Patient has inflammatory arthritis (e.g. rheumatoid arthritis).
Patient has had major, non-arthroscopic surgery to the study knee.
Patient has an active, local infection or systemic infection.
Patient has a physical, emotional or neurological condition that would compromise compliance with postoperative rehabilitation and follow-up.
Patient has hip arthritis and/or replacement.
Patient has lateral knee compartment disease (e.g. valgus knee).
Patient is pregnant or plans to become pregnant during the course of the study.
Patient is on workman’s compensation.
Serious medical infirmity (e.g. Parkinson’s disease, Alzheimer’s disease, CVA with neurological deficit)
Symptomatic spinal disease.
Age over 80 years.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
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)
Recruitment hospital [1] 902 0
The Sydney Private Hospital - Ashfield
Recruitment hospital [2] 903 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment outside Australia
Country [1] 3223 0
India
State/province [1] 3223 0
New Delhi and Pune
Country [2] 3224 0
Japan
State/province [2] 3224 0
Osaka, Sapporo and Hokkaido
Country [3] 3225 0
Korea, Republic Of
State/province [3] 3225 0
Seoul
Country [4] 3226 0
China
State/province [4] 3226 0
Beijing

Funding & Sponsors
Funding source category [1] 258556 0
Commercial sector/Industry
Name [1] 258556 0
Smith & Nephew
Address [1] 258556 0
85 Waterloo Road
North Ryde NSW 2113
Country [1] 258556 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew
Address
85 Waterloo Road
North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 257694 0
None
Name [1] 257694 0
Address [1] 257694 0
Country [1] 257694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266690 0
Ethics committee address [1] 266690 0
Ethics committee country [1] 266690 0
Date submitted for ethics approval [1] 266690 0
27/01/2011
Approval date [1] 266690 0
Ethics approval number [1] 266690 0

Summary
Brief summary
This study aims to determine whether patients of Asian ethnicity undergoing total knee replacement will benefit from a knee prosthesis with dimensions modified to suit Asian knees.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32262 0
Prof T.K.Kim
Address 32262 0
Seoul National University Bundang Hospital
166 Gumi-ro, Bundang-gu, Seongnam-si,
Gyeonggi-do 463-707
Country 32262 0
Korea, Democratic People's Republic Of
Phone 32262 0
+(82)-31-787-7196
Fax 32262 0
Email 32262 0
osktk@snubh.org
Contact person for public queries
Name 15509 0
Mr Mausam Doctor
Address 15509 0
Smith & Nephew
85 Waterloo Road
North Ryde NSW 2113
Country 15509 0
Australia
Phone 15509 0
+61 2 9857 3802
Fax 15509 0
Email 15509 0
mausam.doctor@smith-nephew.com
Contact person for scientific queries
Name 6437 0
Dr Dr David Liu
Address 6437 0
Fred Mckay House

John Flynn Hospital

Level 8, Suite A, Inland drive

TUGUN QLD 4224
Country 6437 0
Australia
Phone 6437 0
+ 61 7 5598 0205
Fax 6437 0
Email 6437 0
drdliu1@bigpond.com

No information has been provided regarding IPD availability
Summary results
No Results