Unique ID issued by UMIN | UMIN000014022 |
---|---|
Receipt number | R000016332 |
Scientific Title | A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population |
Date of disclosure of the study information | 2014/05/26 |
Last modified on | 2017/08/30 17:12:14 |
A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population
ZiCAS
A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population
ZiCAS
Japan |
Trochanteric fractures (AO 31-A1 to 31-A3)
Orthopedics |
Others
NO
To assess anatomical fit of ZNN Cephalomedullary (CM) Asia Nail and clinical outcomes in patients who undertook CM Asia Nail
Others
Anatomical fit of the nail
Confirmatory
Not applicable
CT Assessments
Radiographic Assessment, Clinical Assessments, and Safety Assessment
Observational
50 | years-old | <= |
Not applicable |
Male and Female
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.
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
100
1st name | |
Middle name | |
Last name | Hiroshi Nagano |
Kagawa Prefectural Central Hospital
Orthopaedic Surgery
1-2-1, Asahimachi, Takamatsu, Kagawa, Japan
087-811-3333
chuobyoin@pref.kagawa.lg.jp
1st name | |
Middle name | |
Last name | Akira Kashima |
Zimmer Biomet G.K.
Clinical Affairs
11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan
03-6402-6610
akira.kashima@zimmerbiomet.com
Zimmer Biomet G.K.
Zimmer Biomet G.K.
Profit organization
NO
香川県立中央病院(香川県)、湘南鎌倉総合病院(神奈川県)、名古屋医療センター(愛知県)、浜脇整形外科病院(広島県)、佐賀県医療センター好生館(佐賀県)、熊本赤十字病院(熊本県)、香川労災病院(香川県)
2014 | Year | 05 | Month | 26 | Day |
Published
Completed
2014 | Year | 05 | Month | 12 | Day |
2014 | Year | 06 | Month | 01 | Day |
2015 | Year | 05 | Month | 31 | Day |
2016 | Year | 01 | Month | 06 | Day |
2016 | Year | 01 | Month | 06 | Day |
2016 | Year | 01 | Month | 06 | Day |
Demographic Info, Operative Info, X-ray/ CT Assessment, Clinical Assessment, Patient Outcome Measurement, Adverse Event Info
2014 | Year | 05 | Month | 21 | Day |
2017 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016332
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