This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally. The study will compare the safety and the effectiveness of two intramedullary nails (the investigational group is TFNA and the control group is PFNA-II).Patients enrolled at each site will be randomized in a ratio of 1:1, i.e. one patient assigned to surgery implanted with TFNA for each patient assigned to PFNA-II. Separate block randomization schedules within each site will be used to ensure equal distribution of treatment and control patients. Up to 15 centers will be approved to participate in this study. Patient will be clinically followed after surgery at 1, 6, 12 and 24 weeks. The data up to and including 24 week follow up visit will be used in determining the primary safety and effectiveness of the TFNA. The primary objective of this study is to evaluate whether fracture union rate, evaluated 24 weeks after proximal femur fracture, for the investigational TFNA intramedullary nail is non-inferior to that for currently available control product PFNA-II in patients with proximal femur fractures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
188
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking University third Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical university
Guangzhou, Guangdong, China
University of Hong Kong shenzhen hospital
Shenzhen, Guangdong, China
The Second AffiliatedHospital of Zhejiang University of Medicine
Hangzhou, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Nantong, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Successful Fracture Union Rate 24 Weeks After Surgery
The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product
Time frame: 24 weeks
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