๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 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 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).