Evaluation in the Perioperative Course of Arthroplasty Treatment
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
- 否
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
PD Dr. Andreas Strauß
Principal Investigator
University Hospital, Bonn
