Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
three cancellous screws
DeviceAll patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Three screws for internal fixation in the three-screw group, and three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
four cancellous screws
DeviceAll patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Four screws for internal fixation in the four-screw group, and the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: three-screw groupActive comparator 1 intervention
Group B: four-screw groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Internal fixation failure rate
defined as the total incidence of internal plant cut-out and fracture
Time frame
from operation to 2-year follow-up after the surgerySecondary outcomes
1
Number of Participants with Bone nonunion
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Time frame
from operation to 9-month follow-up after the surgery2
Harris hip score
the score value is from 0 to 100, and a higher score means a better outcome
Time frame
from operation to 2-year follow-up after the surgery3
operation time
from the incision to internal fixation implanted.
Time frame
intraoperative4
The times of intraoperative fluoroscopy
average 25 milliseconds per X-ray shot, record the number of X-ray shot
Time frame
intraoperativeSponsors and contacts
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Source ClinicalTrials.gov