NCT06713018尚未招募不适用
Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System 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 300 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
- 300
- 试验地点
- 1
- 主要终点
- Perspective frequency
研究概览
简要总结
The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.
Participants will:
- Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
- Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.
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
Perspective frequency
时间窗: 1 day
Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image
次要结局
- Neck shaft angle(1 year)
- Guide needle implantation effect(1 day)
- Fluoroscopy times of needle implantation(1 day)
- Operation time(1 day)
- Operative blood loss(1 day)
- Fracture union(1 year)
- Zarit Burden Interview score(1 year)
- Harris score(1 year)
- SF-36 score(1 year)
研究者
Zhang Wei
Deputy head of orthopedics
Chinese PLA General Hospital
研究点 (1)
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