Sliding compression locking plate to fix fresh femoral neck fractures

Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

This trial tests whether a sliding compression locking plate is safe and works well for adults with fresh femoral neck fractures who need internal fixation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: radiation
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06713291 on ClinicalTrials.gov

What this trial studies

Adults with recent femoral neck fractures who are candidates for surgical internal fixation are enrolled and receive either a sliding compression locking plate or three cannulated compression screws as the implant. The study collects safety and effectiveness outcomes related to fracture healing, implant stability, and complications after surgery. Participants must be able to tolerate anesthesia and agree to follow-up visits for postoperative assessment. Data will be used to compare outcomes between the locking plate approach and the established screw fixation option.

Who should consider this trial

Good fit: Adults aged 18 or older with a recent femoral neck fracture who are suitable for internal fixation and can tolerate surgery and follow-up are ideal candidates.

Not a fit: People with active hip infection, metabolic or radiation-related bone disease, severe hip contracture or muscle loss, allergy to implant materials, or who cannot tolerate surgery are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the locking plate could provide more stable fixation and reduce complications or reoperation rates compared with standard screw fixation.

How similar studies have performed: Other internal fixation methods such as cannulated compression screws and sliding hip devices have established success for many femoral neck fractures, while this specific sliding compression locking plate design appears to be a newer device with more limited published data.

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• the First Centre of PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Chinese PLA General Hosptial — Beijing, China (NOT_YET_RECRUITING)
• the First Medical Center of PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Wei Zhang

Conditions: Fracture of Femoral Neck, fracture of neck of femur, sliding compression locking plate, compression screws