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Not yet recruiting NCT06713018

Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

No phase Interventional Fracture of Neck of Femur

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Three cannulated compression screws by navigation system, Traditional three cannulated compression screws.
Who it may be relevant to
Registry conditions: Fracture of Neck of Femur. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

Overview

The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures. Participants will: * Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures. * Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.

Interventions

  • Procedure Three cannulated compression screws by navigation system
    Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system
  • Procedure Traditional three cannulated compression screws
    Patients with femoral neck fractures treated with traditional three cannulated compression screws

Primary outcome measures

  • Perspective frequency [Time frame: 1 day]
Secondary outcome measures (9)
  • Neck shaft angle [Time frame: 1 year]
  • Guide needle implantation effect [Time frame: 1 day]
  • Fluoroscopy times of needle implantation [Time frame: 1 day]
  • Operation time [Time frame: 1 day]
  • Operative blood loss [Time frame: 1 day]
  • Fracture union [Time frame: 1 year]
  • Zarit Burden Interview score [Time frame: 1 year]
  • Harris score [Time frame: 1 year]
  • SF-36 score [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years old, gender is not limited;
  • Patients diagnosed with femoral neck fracture;
  • Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
  • The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion criteria

  • Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
  • The patient is known to have a history of allergy to one or more implanted materials;
  • Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
  • Active infection of the hip joint or other parts of the body is determined by the investigator;
  • Diagnosed as metabolic bone disease, radiation bone disease, etc.;
  • Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
  • have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
  • The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
  • Other conditions deemed unsuitable for inclusion by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Publications

  • Li M, Tong D, Cheng M, Li J, Ji F, Zhang W. Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 23;15:e88180. doi: 10.2196/88180. PMID 42335459

Identifiers

NCT: NCT06713018 · S2024-341-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗