RecruitingACTRN12611000289910

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.


Sponsor

Smith & Nephew

Enrollment

1,060 participants

Start Date

Apr 26, 2011

Study Type

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

Sex: Both males and femalesMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a knee replacement implant specially designed for people of Asian ethnicity fits better and gives better outcomes than a standard knee replacement. Asian knees are often shaped differently from the Western knees that most implants are based on. The Genesis II Slim knee prosthesis has been modified with this in mind. Researchers will measure fit and how well the knee works after surgery over two years. You may be eligible if: - You need a total knee replacement due to non-inflammatory joint disease (such as osteoarthritis) mainly affecting the inner part of the knee - You are under 80 years old - You are able to attend follow-up appointments for up to 2 years after surgery You may NOT be eligible if: - You do not have enough bone for the implant to attach to - You have inflammatory arthritis (such as rheumatoid arthritis) - You have had major (non-keyhole) surgery on the same knee before - You have an active infection - You have Parkinson's disease, Alzheimer's disease, or a stroke with lasting disability - You are pregnant or plan to become pregnant during the study Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Gen

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)

The Sydney Private Hospital - Ashfield

Australia

John Flynn - Gold Coast Private Hospital - Tugun

Australia

New Delhi and Pune, India

Osaka, Sapporo and Hokkaido, Japan

Seoul, Korea, Republic Of

Beijing, China

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ACTRN12611000289910