This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are divided into the FNS group and the MCS group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of FNS in the Chinese population, and verify the safety and efficacy of FNS for patients with femoral neck fracture.
Age ≥18 years
Patients with unilateral femoral neck fractures that will be treated with internal fixation
According to AO fracture classification, subjects with the fracture type (31-B)
Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
Subject does not provide voluntary consent to participate in the study.
The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)
The subjects were pregnant or lactating women.
The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
Parallel
FNS
Deviceperform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
MCS
Devicethree cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
Internal fixation failure rate
defined as the total incidence of internal plant cut-out and fracture.
Number of Participants with Bone nonunion
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Harris hip score
the score value is from 0 to 100, and a higher score means a better outcome
operation time
from the incision to internal fixation implanted.
The times of intraoperative fluoroscopy
average 25 milliseconds per X-ray shot, record the number of X-ray shot
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Peking University Third Hospital
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Beijing Jishuitan Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Tianjin Hospital
Collaborator
The Fuzhou No 2 Hospital
Collaborator
Xi'an Honghui Hospital
Collaborator
West China Hospital
Collaborator
