NIPH Clinical Trials Search

The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Severe knee pain and disability
Date of first enrollment	2011/04/01
Target sample size	200
Countries of recruitment	Japan,Europe
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	Clinical outcomes evaluated by the Knee Society assessment scoring system
Secondary Outcome	-The functional outcome evaluated by the Knee Society functional scoring system -Radiographic outcome evaluated by anterial -posterial and medial-lateral radiographs -Patient's general health status assessment using the Euro-Qol-5D scoring system (EQ-5D) -The survivorship meaning that the prosthesis has not been explanted, nor is a revision planned or pending

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude criteria	-Patient is skeletally immature. -Patient known to be pregnant. -Varus/valgus deformity with mechanical axis >20 degrees. -Fixed flexion deformity >15 degrees. -Patients with grossly insufficient femoral or tibial bone stock, e.g., due to osteoporosis, metabolic bone disease, congenital anomaly, or previous surgery to the index joint that could affect outcome. -Patients with previously failed knee endoprosthesis of any kind. -Patients with a previous history of infection in the affected joint. -Patient is unwilling or unable to cooperate in a follow-up program.