Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation

NCT04869332 | Recruiting

• 1 other identifier: PekingUTH LY MCS
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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. The internal fixation failure rate (IFFR) and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery.

Conditions

Femoral Neck Fractures; Internal Fixation

Keywords

femoral neck fractures; multiple cancellous screws; RCT

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 (5)

• Number of Participants with Bone nonunion

  from operation to 9-month 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

• Garden index

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

Study Arms (2)

three-screw group

ACTIVE COMPARATOR

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

Device: three cancellous screws

four-screw group

EXPERIMENTAL

the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.

Device: four cancellous screws

Interventions

three cancellous screws DEVICE

All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Three screws for internal fixation in the three-screw group, and three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.

three-screw group

four cancellous screws DEVICE

All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Four screws for internal fixation in the four-screw group, and the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.

four-screw group

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.

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 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

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, M.D.

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

XiangYu Xu, M.D.

CONTACT

+86-15210849431; 307542744@qq.com

Yang Lv, M.D.

CONTACT

lvyang42@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: May 3, 2021
• Study Start: April 8, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)