Trochanteric fractures (AO 31-A1 to 31-A3)
Conditions
Interventions
None listed
Sponsors
Zimmer Biomet G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age of 50 years old or above. 2) Japanese patients (Mongoloid) only 3) Diagnosed with primary closed stable or unstable, intertrochanteric fractures of the femur. 4) Required or completed surgical intervention with CM Asia Nail. 5) Able to read and understand study information sheet, and decide to participate in the study by himself/ herself. Sign Patient Informed Consent Form either by patient own or his/ her representative. 6) Willing and capable of following the Investigator's instructions and complying with the follow-up visits.
Exclusion criteria
Exclusion 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
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