Comparing two types of internal fixation for femoral intertrochanteric fractures

A Prospective Multicenter Cohort Study About Internal Fixation Using Proximal Femoral Universal Nail (PFUN) Versus Proximal Femoral Nail Antirotation (PFNA) for Femoral Intertrochanteric Fracture

This study is testing whether two different types of surgical implants can help people with femoral intertrochanteric fractures heal better and avoid complications after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06277622 on ClinicalTrials.gov

What this trial studies

This prospective multicenter cohort study aims to compare the post-operative implant failure rates between two internal fixation methods, Proximal Femoral Universal Nail (PFUN) and Proximal Femoral Nail Antirotation (PFNA), in patients with femoral intertrochanteric fractures. Patients will be divided into two groups based on their choice of fixation method, and their outcomes will be monitored over a 21-month follow-up period. The study will gather clinical data specifically from the Chinese population to assess the safety and efficacy of PFUN. The primary focus is on the internal fixation failure rate and overall fracture prognosis between the two groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unilateral femoral intertrochanteric fractures classified as AO type 31-A who are eligible for internal fixation.

Not a fit: Patients who do not provide voluntary consent or have conditions that may affect their participation and follow-up will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with femoral intertrochanteric fractures.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in comparing different fixation methods for fractures, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years
2. Patients with unilateral femoral intertrochanteric fractures that will be treated with internal fixation
3. According to AO fracture classification, subjects with the fracture type (31-A)
4. Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
5. 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.
6. The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and followup visits and can cooperate with the research procedures.
7. In-label use of the PFUN and PFNA.

Exclusion Criteria:

1. Subject does not provide voluntary consent to participate in the study.
2. 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.)
3. The subjects were pregnant or lactating women.
4. The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
5. 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).
6. Concurrent hip osteoarthritis.
7. Fractures where the operative treatment will occur more than three weeks after the primary injury
8. Patients combined with other bone fractures.
9. Pathological fracture (e.g., primary or metastatic tumor)
10. Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome
11. Multiple systemic injuries judged by researchers not suitable for enrollment.
12. Revision surgeries (for example, due to malunion, nonunion or infection)
13. 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
14. Patients with anaesthetic and surgical contraindications
15. Patients known to be allergic to implant components
16. 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)
17. Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
18. 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.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yuan Cao, MD

Conditions Femoral Intertrochanteric Fractures; internal fixation; PFUN and PFNA; multicenter randomized controlled clinical trial; internal fixation failure rate