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Compares treatment options for Femoral Neck Fractures
Official title Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
ClinicalTrials.gov ID: NCT04869332
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Patients with unilateral femoral neck fractures that will be treated with internal fixation
- According to AO fracture classification, people with the fracture type (31-B)
- people (with the help of relatives) can understand the informed documents and patient questionnaires.
- people (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of...
You likely can't join if
- Subject does not provide voluntary consent to participate in the study.
- The researcher believes that the people have conditions that affect the participation and follow-up of this study. (for example, the patient lives in...
- The people were pregnant or lactating women.
- The researchers believe that the people 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.
See the full eligibility criteria
- Age ≥18 years
- Patients with unilateral femoral neck fractures that will be treated with internal fixation
- According to AO fracture classification, people with the fracture type (31-B)
- people (with the help of relatives) can understand the informed documents and patient questionnaires.
- people (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.
- Subject does not provide voluntary consent to participate in the study.
- The researcher believes that the people 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...
- The people were pregnant or lactating women.
- The researchers believe that the people 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...
- Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
- people participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.