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

Launched by CHINESE PLA GENERAL HOSPITAL · Dec 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat fresh femoral neck fractures, which are breaks in the upper part of the thigh bone near the hip. The study will evaluate an orthopedic surgical navigation system, which is a technology that helps guide surgeons during the operation. Participants in the trial will receive treatment using either this new navigation system or the traditional method involving cannulated compression screws, which are special screws used to stabilize the fracture.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with a femoral neck fracture that requires surgery. They should also be able to tolerate the surgery. If someone joins the study, they will have follow-up visits at the clinic one month, three months, six months, and one year after their surgery to check on their recovery and health. It's important to know that the trial is not yet recruiting participants, so there’s no need to apply just yet.

Gender

ALL

Eligibility criteria

• 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.