NIPH Clinical Trials Search

UMIN ID: UMIN000026639

Registered date:23/03/2017

Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail with Anterior Support Screw (ASS) versus Conventional Technique

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedFracture type is classified as 3-partB or 4-part fracture in 3D-CT classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT assessment.
Date of first enrollment2017/03/08
Target sample size240
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)At surgery, intervention group using ZNN CM Asia with ASS technique. At surgery, conventional group using ZNN CM Asia without ASS technique.


Primary OutcomeThe maintenance rate of postoperative 2-3 week reduction position.
Secondary OutcomeThe influence of surgery time / fracture type / postoperative reduction position / with or without ASS technique on CT evaluation.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Patient who cannot take CT image within 3 days after surgery. 2. Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

Related Information


public contact
Name Yukako Shiraishi
Address 11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan Japan 105-0011
Telephone 03-6402-6771
Affiliation Zimmer Biomet G.K. Clinical Affairs
scientific contact
Name Takashi Maehara
Address 3-1 Joto-cho 3-chome, Marugame, Kagawa, 763-8502 Japan Japan
Telephone 0877-23-3111
Affiliation Kagawa Rosai Hospital Orthopaedic Surgery