NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000008113

Registered date:06/06/2012

A multi-center, prospective study of Zimmer Natural Nail System GT Femoral Nails

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPrimary femoral shaft fractures (AO 32-A1 to 32-C3)
Date of first enrollment2012/06/01
Target sample size100
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1).Patient with obliteration of medullary canal due to a previous fracture or tumor 2).Patient with excessive bow or deformity at bone shaft 3).Patient with insufficient bone substance or bone quality 4).Patient with all concomitant diseases that can impair the functioning and the success of the implant 5).Patient with infection 6).Patient with insufficient blood circulation 7).Patient is skeletally immature 8).Patient who is suspected to have a metal allergy 9).Patient who is pregnant, suspected pregnancy or plan to get pregnant during the study observation period 10).Patient with pathologic fracture (including fracture caused by long-term treatment of Bisphosphonate) 11).Patient with periprosthetic fracture 12).Patient with history of deep vein thrombosis (DVT) or pulmonary embolism (PE) 13).Patient who is under medication for Diabetes mellitus (DM) or with suspected DM, and whose HbA1c NGSP (National Glycohemoglobin Standardization Program) is equal or over than 6.5 % or JDS(Japan Diabetes Society) is equal or over than 6.1% 14).Patient with osseous metabolic diseases (excluding osteoporosis) 15).Patient with bilateral fracture or history of fracture at the other side on femur 16).Patient with any comorbidity (e.g. dementia, schizophrenia, depression, panic disorder or generalized anxiety disorder) which may affect the ability of informed consent or completion of assessments 17).Patient who will have to undergo THA, TKA or any operation of lower extremities within 6 months after enrollment 18).Patient who underwent THA, TKA or any operation of lower extremities within 6 months before enrollment

Related Information

Contact

public contact
Name Akira Kashima
Address 2-11-1 Shibakoen, Minato-ku, Tokyo, Japan Japan
Telephone 03-6402-6773
E-mail akira.kashima@zimmerbiomet.com
Affiliation Zimmer Biomet G.K. Clinical Affairs
scientific contact
Name Hiroshi Nagano
Address 2-1-2 Asahicho, Takamatsu, Kagawa 760-8557, Japan Japan
Telephone 087-811-3333
E-mail chuobyoin@pref.kagawa.lg.jp
Affiliation Kagawa Prefectural Central Hospital Orthopaedic Surgery