NIPH Clinical Trials Search

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) studied	Primary femoral shaft fractures (AO 32-A1 to 32-C3)
Date of first enrollment	2012/06/01
Target sample size	100
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	CT Assessments
Secondary Outcome	Radiographic Assessment, Clinical Assessments and Safety Assessment

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	75years-old
Gender	Male and Female
Include criteria
Exclude criteria	1).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