跳至主要内容
临床试验/NCT02981823
NCT02981823Unknown不适用

Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty: a Prospective, Single-center, Self-controlled Trial With 2-year Follow-up

Hebei Medical University Third Hospital0 个研究点目标入组 25 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
主要终点
Harris hip scores

研究概览

简要总结

To provide information on reducing the incidence of periprosthetic fractures during hip replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic fractures and their effects on hip functional recovery.

详细描述

History and current related studies Periprosthetic fractures are one of the challenges for orthopedic surgeons that are more likely to appear during hip replacement with a cementless prosthesis. Hip replacement with a collum femoris preserving (CFP) prosthetic stem allows the preservation of the femoral neck and preserves bone tissues as much as possible for prosthetic revision in the future. However, the occurrence of periprosthetic fractures will result in a failure surgery. Existing evidence has shown that although hip replacement with the CFP prosthetic stem can reduce complications and pain, periprosthetic fractures that are more likely to occur during the surgery badly impact functional recovery in patients.

Adverse events Adverse events which occurred during the follow-up, including hip pain, prosthetic loosening, spinal cord and nerve injuries, soft tissue infection and poor prosthetic position, were recorded.

If severe adverse events occurred during the follow-up, their details including the date of occurrence, type of adverse events and measures taken were recorded and reported to the principal investigator and the institutional review board within 24 hours.

Data collection, management, analysis, and open access Data collection Clinical data, including demographic data, disease diagnosis, accompanying diseases, allergic history (drug allergy) and adverse events, were collected and summarized using standardized case report forms. These data were processed using Epidata software and electronically input using double entry system.

Data management After database confirmation, only the project manager was able to access the database. The locked data were unable to be altered and were preserved by the Third Hospital of Hebei Medical University.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnostic and staging criteria in line with the Expert consensus on diagnosis and treatment of adult femoral head necrosis
  • Femoral head necrosis of Association Research Circulation Osseous (ARCO) stages III-IV
  • Unilateral femoral head necrosis
  • Age < 50 years
  • Both genders

排除标准

  • Advanced osteoarthritis
  • Secondary osteoarthritis due to acetabular dysplasia
  • Ankylosing spondylitis involving the hip joint
  • Rheumatoid arthritis
  • Inflammatory inflammation of the hip joint
  • Tumor lesions in the hip joint
  • Unable or refusal to sign the informed consent

结局指标

主要结局

Harris hip scores

时间窗: Changes of baseline and 6 months after operation

To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor \<70 points. The higher score indicates the better function of the hip.

次要结局

  • X-ray image(Changes of baseline and month 6, month 12, month 24 after operation)

研究者

发起方
Hebei Medical University Third Hospital
申办方类型
Other
责任方
Sponsor

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