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 |
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Health condition(s) or Problem(s) studied | Fracture 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 enrollment | 2017/03/08 |
Target sample size | 240 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | At surgery, intervention group using ZNN CM Asia with ASS technique. At surgery, conventional group using ZNN CM Asia without ASS technique. |
Outcome(s)
Primary Outcome | The maintenance rate of postoperative 2-3 week reduction position. |
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Secondary Outcome | The influence of surgery time / fracture type / postoperative reduction position / with or without ASS technique on CT evaluation. |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. 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
Primary Sponsor | Zimmer Biomet G.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Zimmer Biomet G.K. |
Secondary ID(s) | NCT03196193,jRCTs032180353 |
Contact
public contact | |
Name | Yukako Shiraishi |
Address | 11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan Japan 105-0011 |
Telephone | 03-6402-6771 |
yukako.nishino@zimmerbiomet.com | |
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 |
yukako.nishino@zimmerbiomet.com | |
Affiliation | Kagawa Rosai Hospital Orthopaedic Surgery |