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

Chinese PLA General Hospital1 site in 1 country300 target enrollmentDecember 10, 2024

ConditionsFracture of Neck of Femur

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fracture of Neck of Femur
Sponsor: Chinese PLA General Hospital
Enrollment: 300
Locations: 1
Primary Endpoint: Perspective frequency
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 10, 2024

End Date

October 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Zhang Wei

Deputy head of orthopedics

Chinese PLA General Hospital

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.