Anthropometric Evaluation of a New Asian Specific Knee Prosthesis - The Genesis II Slim
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.
Smith & Nephew
1,060 participants
Apr 26, 2011
Interventional
Conditions
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.
Eligibility
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Interventions
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.
Locations(6)
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ACTRN12611000289910