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
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
- 否
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)
