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

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Fracture of Neck of Femur

Treatments: Procedure: Three cannulated compression screws by navigation system; Procedure: Traditional three cannulated compression screws

Study type: Interventional

Funder types: Other

Identifiers

NCT06713018

S2024-341-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

Three cannulated compression screws by navigation system

Experimental group

Treatment:

Procedure: Three cannulated compression screws by navigation system

Traditional three cannulated compression screws

Placebo Comparator group

Treatment:

Procedure: Traditional three cannulated compression screws