About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- FNS
- MCS
Treatment groups
Sponsors and collaborators
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