A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture

NCT06277622 | Unknown FDA Device

• 1 other identifier: PekingUTH ZFCY PFUN
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture.

Conditions

Femoral Intertrochanteric Fractures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Internal fixation failure rate

  defined as the total incidence of internal plant cut-out and fracture.

  from operation to 21-month follow-up after the surgery

Secondary Outcomes (5)

• Number of Participants with Bone nonunion

  from operation to 21-month follow-up after the surgery

• Harris hip score

  from operation to 21-month follow-up after the surgery

• operation time

  intraoperative

• The times of intraoperative fluoroscopy

  intraoperative

• Number of Participants with Postoperative adverse events

  from operation to 21-month follow-up after the surgery

Study Arms (2)

Proximal Femoral Universal Nail (PFUN)

EXPERIMENTAL

Device: PFUN

Proximal Femoral Nail Antirotation (PFNA)

ACTIVE COMPARATOR

Device: PFNA

Interventions

PFUN DEVICE

perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.

Proximal Femoral Universal Nail (PFUN)

PFNA DEVICE

perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.

Proximal Femoral Nail Antirotation (PFNA)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients with unilateral femoral intertrochanteric fractures that will be treated with internal fixation
• According to AO fracture classification, subjects with the fracture type (31-A)
• 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 followup visits and can cooperate with the research procedures.
• In-label use of the PFUN and PFNA.

You may not qualify if:

• 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.
• 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).
• Concurrent hip osteoarthritis.
• Fractures where the operative treatment will occur more than three weeks after the primary injury
• Patients combined with other bone fractures.
• Pathological fracture (e.g., primary or metastatic tumor)
• 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
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Yanqing Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Yuan Cao, MD

CONTACT

+86010-82266699; cy6415@126.com

Fang Zhou, MD

CONTACT

+86010-82267010; zhouf@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)