Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation (NCT04869332) | Clinical Trial Compass
RecruitingNot Applicable
Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
China290 participantsStarted 2021-04-08
Plain-language summary
This study is a prospective randomized controlled clinical study. Patients with femoral neck fracture (AO classification 31-B) will be randomly divided into three-screw fixation group and four-screw fixation group. The internal fixation failure rate (IFFR) and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.)
* The subjects were pregnant or lactating women.
* The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
* Garden classification III and IV of femoral neck fracture patients older than 65 years
* Concurrent hip osteoarthritis.
* Fractures where the operative treatment will occur more than three we…
What they're measuring
1
Internal fixation failure rate
Timeframe: from operation to 2-year follow-up after the surgery