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 |
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Health condition(s) or Problem(s) studied | Trochanteric fractures (AO 31-A1 to 31-A3) |
Date of first enrollment | 2014/06/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | CT Assessments |
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Secondary Outcome | Radiographic Assessment, Clinical Assessments, and Safety Assessment |
Key inclusion & exclusion criteria
Age minimum | 50years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) 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
Primary Sponsor | Zimmer Biomet G.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Zimmer Biomet G.K. |
Secondary ID(s) |
Contact
public contact | |
Name | Akira Kashima |
Address | 11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan Japan |
Telephone | 03-6402-6610 |
akira.kashima@zimmerbiomet.com | |
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 |
chuobyoin@pref.kagawa.lg.jp | |
Affiliation | Kagawa Prefectural Central Hospital Orthopaedic Surgery |