Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Fracture of Femoral Neck

Treatments: Procedure: Three cannulated compression screws; Procedure: Sliding compression locking plate

Study type: Interventional

Funder types: Other

Identifiers

NCT06713291

Chinese PLA General Hosptial

Details and patient eligibility

About

To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures

Enrollment: 1,150 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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1,150 participants in 2 patient groups, including a placebo group

Sliding compression locking plate

Experimental group

Description:

Patients with femoral neck fracture were treated with sliding compression locking plate internal fixation.

Treatment:

Procedure: Sliding compression locking plate

Three cannulated compression screws

Placebo Comparator group

Description:

The patients with femoral neck fracture were treated with three cannulated compression screws.

Treatment:

Procedure: Three cannulated compression screws