None listed
Conditions
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.
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
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.
Sponsors
Smith & Nephew
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
0 to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed