NCT06713291尚未招募不适用
Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 1,150 人开始时间: 2024年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Femoral neck shortened
研究概览
简要总结
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Femoral neck shortened
时间窗: 1 year
The difference in femoral neck length between 1 week post-surgery and 6 months and 12 months post-surgery, measured via X-ray and CT imaging examinations.
次要结局
- Time of operation(1 day)
- Blood loss(1 day)
- Bone union(1 year)
- Zarit Burden Interview（ZBI）(1 year)
- SF-36 Score(1 year)
- Neck shaft angle(1 year)
- The effectiveness of guide pin implantation(1 day)
研究者
Zhang Wei
Professor
Chinese PLA General Hospital
研究点 (1)
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