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Starting soon Not applicable

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

NCT06713018 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-12-10
Last updated
2024-12-03

Condition(s) studied

Fracture of Neck of Femur

Investigational drug(s) / intervention(s)

Three cannulated compression screws by navigation systemTraditional three cannulated compression screws

Three cannulated compression screws by navigation system: Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system

Traditional three cannulated compression screws: Patients with femoral neck fractures treated with traditional three cannulated compression screws

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years old, gender is not limited; 2. Patients diagnosed with femoral neck fracture; 3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery; 4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study. Exclusion Criteria: 1. 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; 2. The patient is known to have a history of allergy to one or more implanted materials; 3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases; 4. Active infection of the hip joint or other parts of the body is determined by the investigator; 5. Diagnosed as metabolic bone disease, radiation bone disease, etc.; 6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain; 7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.; 8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate; 9. Other conditions deemed unsuitable for inclusion by the investigator.

Primary outcome measure(s)

  • Perspective frequency — 1 day
    Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06713018 on ClinicalTrials.gov ↗ ← All trials in China