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

NCT04462172 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2021-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Femoral Neck Fractures

Interventions

DEVICE

FNS

perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.

DEVICE

MCS

three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • Beijing Jishuitan Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Tianjin Hospital

    collaborator OTHER

  • The Fuzhou No 2 Hospital

    collaborator OTHER

  • Xi'an Honghui Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Fang Zhou, MD · Peking University Third Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462172 on ClinicalTrials.gov