A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture

NCT04462172 | Unknown FDA Device

• 1 other identifier: PekingUTH ZF FNS
• Study Type: interventional
• Target: 290
• 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 neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are divided into the FNS group and the MCS 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 FNS in the Chinese population, and verify the safety and efficacy of FNS for patients with femoral neck fracture.

Conditions

Femoral Neck Fractures

Keywords

femoral neck fracture; internal fixation; FNS and MCS; 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 2-year follow-up after the surgery

Secondary Outcomes (7)

• Number of Participants with Bone nonunion

  from operation to 2-year follow-up after the surgery

• Harris hip score

  from operation to 2-year follow-up after the surgery

• operation time

  intraoperative

• The times of intraoperative fluoroscopy

  intraoperative

• Number of Participants with Postoperative adverse events

  from operation to 2-year follow-up after the surgery

Study Arms (2)

Synthes Femoral Neck System (FNS)

EXPERIMENTAL

Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression.

Device: FNS

Multiple cancellous screws (MCS)

ACTIVE COMPARATOR

Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.

Device: MCS

Interventions

FNS DEVICE

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

Synthes Femoral Neck System (FNS)

MCS DEVICE

three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.

Multiple cancellous screws (MCS)

Eligibility Criteria

• Age: 18 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 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 and FNS.

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.
• 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 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
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Beijing Jishuitan Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Tianjin Hospital: collaborator
• The Fuzhou No 2 Hospital: collaborator
• Xi'an Honghui Hospital: collaborator
• West China Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Fang Zhou, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiangyu Xu, MD

CONTACT

+86-15210849431; 307542744@qq.com

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 neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up.The patients are divided into the FNS group and the MCS group according to the internal fixation they choose.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 8, 2020
• Study Start: September 30, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)