A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral N… (NCT04462172) | Clinical Trial Compass
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A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
China290 participantsStarted 2021-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.
✓. The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and follow-up visits and can cooperate with the research procedures.
✓. In-label use of the MCS and FNS.
Exclusion criteria
✕. 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.)
What they're measuring
1
Internal fixation failure rate
Timeframe: from operation to 2-year follow-up after the surgery