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临床试验/NCT07799818
NCT07799818招募中不适用

Evaluation in the Perioperative Course of Arthroplasty Treatment

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
SF 12 Questionnaire

研究概览

简要总结

The aim of the study is to examine patients after knee and hip endoprosthesis in the longitudinal section and to evaluate the surgical outcome.

详细描述

In 2022, around 255,000 total hip arthroplasties and around 200,000 total knee arthroplasties were implanted in Germany and treated on an inpatient basis.

However, studies show that 15-30% of patients are not satisfied with the postoperative outcome of total knee arthroplasty. Various factors, such as preoperative pain and mental and physical health, are important for subjective satisfaction. For the objective functional results, other factors such as the indication, age and lifestyle are added, which can influence the postoperative result.

These figures initially relate to primary joint replacement. However, it is not uncommon for a repeat procedure, known as a revision, to be indicated postoperatively. In Germany, for example, 12.6% of knee endoprostheses required revision in 2018. Studies have shown that the most common reasons for hip revision are aseptic loosening in 23% of cases, functional instability in 22% and periprosthetic infection (PPI) in 22%. With an incidence of 1-2% and increasing case numbers, PPI is a relevant problem in arthroplasty treatment. In the postoperative course, a bacterial infection of the prosthesis-bearing bone, the joint and/or the surrounding tissue occurs. If symptoms persist or the prosthesis is unstable, a one-stage or two-stage prosthesis replacement with subsequent antibiotic therapy is performed. When choosing the treatment, the focus should be on improving quality of life, which includes reducing pain, maintaining function and, last but not least, reducing infection-related morbidity and mortality.

In order to be able to comprehensively track the course of treatment of joint surgery patients (preoperative condition, surgery performed, subsequent hospitalization, postoperative outcome, any subsequent complications and further interventions), structural and temporally consistent documentation and examinations of patients are required.

The aim of the study is to correlate the multiple parameters that influence the course of treatment and the surgical outcome and thus obtain a holistic picture of the patient in order to improve joint surgery care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • There is an indication for primary knee or hip replacement or revision.
  • The subject is over 18 years of age.
  • Written consent is given if the subject is fully responsible.

排除标准

  • A known pregnancy
  • A known mental or pain-associated illness
  • Illness of an airborne infectious disease with an increased risk of mortality and morbidity
  • Patient intolerances or restrictions that make participation in the study impossible

研究组 & 干预措施

Revision hip prosthesis

Patients who receive a revision of the hip prosthesis.

干预措施: Joint replacement (Procedure)

Revision knee prosthesis

Patients who receive a revision of the knee prosthesis.

干预措施: Joint replacement (Procedure)

Primary knee prosthesis

Patients who receive a primary knee prosthesis.

干预措施: Joint replacement (Procedure)

Primary hip prosthesis

Patients who receive a primary hip prosthesis.

干预措施: Joint replacement (Procedure)

结局指标

主要结局

SF 12 Questionnaire

时间窗: preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

Health-related quality of life assessed by the SF-12 (score for physical components (PCS) and total score for mental components (MCS) - higher values mean better health, lower values mean worse health with a statistical mean of the total score of 50 (SD 10) (1-100)

Hand-held dynamometer

时间窗: preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

Hand grip force using a hand dynamometer in absolute values (in kg).

Dual-Energy X-Ray Absorptiometry

时间窗: preoperative (approx. 1Day)

Bone density values by DXA measurement (T- or Z-values as deviation of the measured value from predefined mean values. T-Score ≤ -1 = osteopenia; T-Score ≤ -2,5 = osteoporosis.

次要结局

  • Joint examination (HJHS)(preoperative (approx. 1Day))
  • Hip examination (Harris Hip Score)(preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative)
  • Knee examination (Knee Society Score)(preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative)
  • Blood samples(preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative)
  • Biomaterial(during operation)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. Andreas Strauß

Principal Investigator

University Hospital, Bonn

研究点 (1)

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