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临床试验/NCT04959370
NCT04959370已完成不适用

Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Internal fixation failure rate

研究概览

简要总结

For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Patients with DHS internal fixation have earlier postoperative weight bearing, which is conducive to functional exercise of the injured limb. DHS internal fixation system is recommended for patients with unstable fractures and severe osteoporosis.

详细描述

Objective

To compare the clinical effect of dynamic hip screw (DHS) and cannulated compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases were divided into two groups according to internal fixation: 44 cases in the DHS group and 47 cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative load, Harris scoring and the complications such as postoperative necrosis of femoral head and shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds of fixation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fresh femoral neck fracture
  • can walk before fracture
  • less than 65 years old

排除标准

  • Patients combined with other bone fractures.
  • Pathological fracture (e.g., primary or metastatic tumor)
  • Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome.
  • Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection)
  • Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
  • Patients known to be allergic to implant components
  • Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
  • Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).

结局指标

主要结局

Internal fixation failure rate

时间窗: from operation to 1-year follow-up after the surgery

defined as the total incidence of internal plant cut-out and fracture.

次要结局

  • Harris hip score(from operation to 1-year follow-up after the surgery)
  • operation time(intraoperation)
  • The times of intraoperative fluoroscopy(intraoperation)
  • Garden index(from operation to 1-year follow-up after the surgery)
  • Number of Participants with Postoperative adverse events(from operation to 1-year follow-up after the surgery)
  • Number of Participants with Bone nonunion(from operation to 1-year follow-up after the surgery)
  • A 12-Item Short-Form Health Survey (SF-12)(from operation to 1-year follow-up after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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