RecruitingNot ApplicableNCT06713291

Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of 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


Sponsor

Chinese PLA General Hospital

Enrollment

1,150 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age >=18 years old, gender is not limited;
  • Patients diagnosed with femoral neck fracture;
  • Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
  • The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion Criteria9

  • 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;
  • The patient is known to have a history of allergy to one or more implanted materials;
  • Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
  • Active infection of the hip joint or other parts of the body is determined by the investigator;
  • Diagnosed as metabolic bone disease, radiation bone disease, etc.;
  • Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
  • have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
  • The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
  • Other conditions deemed unsuitable for inclusion by the investigator.

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Interventions

PROCEDURESliding compression locking plate

The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.

PROCEDUREThree cannulated compression screws

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


Locations(3)

the First Centre of PLA General Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hosptial

Beijing, China

the First Medical Center of PLA General Hospital

Beijing, China

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NCT06713291