NIPH Clinical Trials Search

UMIN ID: UMIN000005334

Registered date:28/03/2011

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) studiedSevere knee pain and disability
Date of first enrollment2011/04/01
Target sample size200
Countries of recruitmentJapan,Europe
Study typeObservational


Primary OutcomeClinical 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 minimum20years-old
Age maximum80years-old
GenderMale 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.

Related Information


public contact
Name Akira Kashima
Address 7F, Kamiyacho Prime Place, 1-17, Toranomon 4-chome, Minato-ku, Tokyo, Japan Japan
Telephone 03-6402-6610
Affiliation Zimmer K.K. Clinical Affairs
scientific contact
Name Ryuichi Gejo
Address 2630 Sugitani Toyama-City Toyama, Japan Japan
Telephone 076-434-7353
Affiliation University of Toyama Department of Orthopaedic Surgery, Faculty of Medicine