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

UMIN ID: UMIN000005334

Registered date:28/03/2011

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

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
• 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.

Related Information

• Primary Sponsor: Zimmer K.K.
• Source(s) of Monetary Support: Zimmer K.K.