跳至主要内容
临床试验/NCT04665180
NCT04665180进行中(未招募)不适用

Determinants for Return to Work After Primary Knee Arthroplasty: a Prospective Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
88
试验地点
1
主要终点
Quickscan questionnaire

研究概览

简要总结

The increase of end-stage osteoarthritis (OA) in an increasingly younger population is directly correlated with the rising incidence of obesity. As a result, knee arthroplasty (KA), which is a definitive end-stage treatment option, is increasingly performed on working age people. Knowledge and understanding of the underlying factors that drive the ability for people to return to work is crucial.

First and foremost, the investigators would have like to have a clear idea of the percentage of patients who return to work and at what time postoperatively. The investigators would also determine the different factors influencing employment in the patient population after undergoing a knee arthroplasty and register the evolution in the necessity of pain medication pre-and postoperatively. Ideally, the investigators can include a short questionnaire regarding return to sports to gather valuable information.

详细描述

The increase of end-stage osteoarthritis (OA) in an increasingly younger population is directly correlated with the rising incidence of obesity. As a result, knee arthroplasty (KA), which is a definitive end-stage treatment option, is increasingly performed on working age people. Knowledge and understanding of the underlying factors that drive the ability for people to return to work is crucial.

First and foremost, the investigators would have like to have a clear idea of the percentage of patients who return to work and at what time postoperatively. The investigators would also determine the different factors influencing employment in the patient population after undergoing a knee arthroplasty and register the evolution in the necessity of pain medication pre-and postoperatively. Ideally, the investigators can include a short questionnaire regarding return to sports to gather valuable information.

Adult patients with an indication for primary knee arthroplasty (total + unicondylar) can take part in the study. This will be decided by clinical examination and radiographic evaluation, having the result of the previous therapies and the patient-specific needs in mind (standard of care). The patients have to be younger than or equal to 63 years old at the time of surgery and actively been working 2 years prior to surgery.

In line with the standard of care, the patients will be seen after 4-8 weeks, 3-4 months and 1 year postoperatively. Radiological examinations are foreseen at 4-8 weeks and 1 year postoperatively (standard of care). Pre-operatively, a general questionnaire is filled in by the patients. The patient questionnaires Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS), Forgotten Knee Joint Score, Quickscan, Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ) will be filled in by the patients during the screening visit and on each consultation at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. The Tegner score will be filled in by the patients pre-operatively and at 1 year postoperatively.

研究设计

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

入排标准

年龄范围
18 Years 至 63 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Informed consent
  • •Primary knee arthroplasty (total + unicondylar)
  • •Patients younger than or equal to 63 years old at the time of surgery
  • •Actively been working 2 year prior to surgery.

排除标准

  • •No informed consent
  • •Revision surgery
  • •Patients older than 63 years of age at the time of surgery
  • •Patients who haven't were unable to work due to other, non-knee related, health issues

研究组 & 干预措施

Primary knee arthroplasty

Experimental

Questionnaires

干预措施: Primary knee arthroplasty (Diagnostic Test)

结局指标

主要结局

Quickscan questionnaire

时间窗: Time frame of 1,5 year postoperatively

Return to work is measured using the Quickscan questionnaire during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. In the Quickscan questionnaire, all questions are scored ranging from "0" totally disagree to "5" totally agree.

Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ)

时间窗: Time frame of 1,5 year postoperatively

Return to work is measured using the Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ) during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. The WORQ is a patient reported outcome measure (PROM) in which the patient indicates his experiences in 13 knee-stressing activities in the past week by scoring the difficulty the patient experienced. A formula is used to calculate the total score that ranges from 0 ('very much difficulty/ can't do') to 4 ('no difficulty at all').

次要结局

  • Return to sports(within a time frame of 1 year postoperatively)
  • Knee rate and patient's functional abilities(within a time frame of 1,5 year postoperatively)
  • Knee symptoms(within a time frame of 1,5 year postoperatively)
  • Awareness of knee joint/knee prothesis in daily life(within a time frame of 1,5 year postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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