NCT06713031尚未招募不适用
Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 400 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
- 400
- 试验地点
- 1
- 主要终点
- Fracture healing rate
研究概览
简要总结
A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old 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, gender not specified;
- •Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
- •Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
- •Participants or their legal representatives are informed about the nature of this study and agree to participate.
排除标准
- •Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
- •Known history of hypersensitivity to one or more implanted materials by the patient;
- •Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
- •Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
- •Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
- •Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
- •Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
- •Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
- •Other situations where the investigator deems the participant unsuitable for inclusion.
结局指标
主要结局
Fracture healing rate
时间窗: 1 year
次要结局
- Femoral head necrosis(1 year)
- Harris score(1 year)
- VAS score(1 year)
- Complications(1 year)
研究者
Zhang Wei
Deputy head of orthopedics
Chinese PLA General Hospital
研究点 (1)
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