A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Third Hospital

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

290 Participants
are divided into 2 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