Primary femoral shaft fractures (AO 32-A1 to 32-C3)
Conditions
Interventions
None listed
Sponsors
Zimmer K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1).Patient with primary femoral shaft (AO 32-A1 to 32-C3) fractures 2).Asia to Mongoloid patients only 3).Age (at the day of obtainment of consent): 18 to 75 years 4).Sex: Both males and females 5).Patient who is able to provide consent and sign the consent form 6).Patient is willing and able to complete scheduled follow-up evaluations as described in the informed consent 7).Patient who underwent acute and/or preoperative treatment such as Ex-Fix 8).Patient with independent walking ability before the fracture
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT Assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Assessment, Clinical Assessments and Safety Assessment | — |
Countries
Japan
Contacts
Public ContactAkira Kashima
Zimmer Biomet G.K. Clinical Affairs
Outcome results
None listed