Recruiting NCT06713291
Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sliding compression locking plate, Three cannulated compression screws.
- Who it may be relevant to
- Registry conditions: Fracture of Femoral Neck. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
Overview
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures
Interventions
- Procedure Sliding compression locking plate
The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate. - Procedure Three cannulated compression screws
The patients with femoral neck fracture were treated with three cannulated compression screws.
Primary outcome measures
- Femoral neck shortened [Time frame: 1 year]
Secondary outcome measures (8)
- Neck shaft angle [Time frame: 1 year]
- The effectiveness of guide pin implantation [Time frame: 1 day]
- Time of operation [Time frame: 1 day]
- Blood loss [Time frame: 1 day]
- Bone union [Time frame: 1 year]
- Zarit Burden Interview（ZBI） [Time frame: 1 year]
- SF-36 Score [Time frame: 1 year]
- Harris Hip Score: [Time frame: hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- the First Centre of PLA General Hospital — Beijing
- Chinese PLA General Hosptial — Beijing
- the First Medical Center of PLA General Hospital — Beijing
Identifiers
NCT: NCT06713291 · Chinese PLA General Hosptial