NIPH Clinical Trials Search

UMIN ID: UMIN000014022

Registered date:26/05/2014

A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedTrochanteric fractures (AO 31-A1 to 31-A3)
Date of first enrollment2014/06/01
Target sample size100
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeCT Assessments
Secondary OutcomeRadiographic Assessment, Clinical Assessments, and Safety Assessment

Key inclusion & exclusion criteria

Age minimum50years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) A medullary canal obliterated by a previous fracture or tumor 2) Bone shaft having excessive bow or deformity 3) Lack of bone substance or bone quality which makes stable seating of the implant impossible 4) Concomitant diseases that can impair the functioning and the success of the implant 5) Infection 6) Insufficient blood circulation 7) Skeletally immature 8) Pregnant, suspected pregnancy or plan to get pregnant during the study observation period 9) Patients who cannot conduct CT scan examination within 3 days after the surgery 10) Patient with any comorbidities which may affect the ability of informed consent or completion of assessments

Related Information


public contact
Name Akira Kashima
Address 11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan Japan
Telephone 03-6402-6610
Affiliation Zimmer Biomet G.K. Clinical Affairs
scientific contact
Name Hiroshi Nagano
Address 1-2-1, Asahimachi, Takamatsu, Kagawa, Japan Japan
Telephone 087-811-3333
Affiliation Kagawa Prefectural Central Hospital Orthopaedic Surgery