A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population

UMIN ID: UMIN000014022

Registered date:26/05/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Trochanteric fractures (AO 31-A1 to 31-A3)
• Date of first enrollment: 2014/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Zimmer Biomet G.K.
• Source(s) of Monetary Support: Zimmer Biomet G.K.