Comparing three versus four screws for fixing femoral neck fractures
A Prospective Randomised Controlled Clinical Trial: Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures
This study is testing whether using three screws instead of four to fix femoral neck fractures helps patients heal better and have fewer problems over the next two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04869332 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized controlled study that aims to compare the effectiveness of three cancellous screws versus four cancellous screws for the internal fixation of femoral neck fractures classified as AO 31-B. Patients will be randomly assigned to one of the two groups, and their internal fixation failure rates and functional outcomes will be monitored over a follow-up period of up to two years. The study will include 290 participants, with 145 in each group, and will utilize a computer random allocation system for randomization.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with unilateral femoral neck fractures classified as AO 31-B who can provide informed consent.
Not a fit: Patients requiring open reduction for their fractures or those unable to provide voluntary consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal number of screws needed for effective fixation of femoral neck fractures, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on screw fixation techniques, this specific comparison of three versus four screws is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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).
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: XiangYu Xu, M.D.
- Email: 307542744@qq.com
- Phone: +86-15210849431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.