Status:
RECRUITING
Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
Lead Sponsor:
Peking University Third Hospital
Conditions:
Femoral Neck Fractures
Internal Fixation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 f...
Detailed Description
This is a prospective randomized controlled clinical trial. All patients will be randomly divided into 2 groups at a ratio of 1:1. The investigators will use three screws for internal fixation in the ...
Eligibility Criteria
Inclusion
- 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
- 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 weeks after the primary injury
- Patients combined with femoral head fractures(31-C), femoral shaft fractures(32-A/B/C) or femoral trochanteric area fracture (31-A1/A2/A3).
- Pathological fracture (e.g., primary or metastatic tumor)
- Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome
- Multiple systemic injuries judged by researchers not suitable for enrollment.
- Revision surgeries (for example, due to malunion, nonunion or infection)
- Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
- Patients with anaesthetic and surgical contraindications
- Patients known to be allergic to implant components
- Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
- Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
- Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.
- Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT04869332
Start Date
April 8 2021
End Date
December 31 2026
Last Update
May 3 2021
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191