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临床试验/NCT06127719
NCT06127719招募中不适用

The Effects of Surgical Wait Time on Function, Pain and Health Related Quality of Life in Patients Awaiting Knee Arthroplasty: a Prospective Multicenter Cohort Study

Dijklander Ziekenhuis1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Knee function measured with the Oxford knee score (OKS)

研究概览

简要总结

This study prospectively evaluates the effect of surgical wait time on knee function, pain and quality of life in patients waiting for knee arthroplasty (TKA or PKA)

详细描述

Osteoarthritis (OA) is a common condition, leading to pain and disability. The knee is the most affected joint, accounting for almost 80 percent of the total prevalence of OA. The pooled global prevalence of knee OA is 22.9% in individuals aged 40 and over. Correspondingly, there are around 654.1 million individuals with knee OA in 2020 worldwide. The number of people affected with symptomatic knee OA is likely to increase because of the aging population and the obesity epidemic.

Pain is the most important symptom in knee OA. It is intermittent, typically weight bearing and progressive over time. Additional symptoms are crepitus, swelling and morning stiffness. The knee is often swollen and has diminished range of motion (ROM). Not only does OA lead to functional disability, but also influences social participation and quality of life.

Knee OA is a progressive disease, which requires continuous management. Treatment consists of conservative as well as invasive treatments, as described in national and international guidelines. First line treatments are patient education, physical therapy, weight loss, different pharmacological treatments and intra-articular steroid injections. More advanced OA may require surgery. Knee arthroplasty, (total knee arthroplasty (TKA) or partial knee arthroplasty (PKA)) can provide excellent pain relief, remarkable deformity correction, and satisfactory functional recovery.

Since the beginning of the covid19 pandemic, surgeons have been asked to only perform essential surgeries in order to preserve healthcare resources. This has led to an increase in patients on the waiting list, resulting in unusually high wait times. Despite the decrease in covid related healthcare consumption, waiting times are yet to return to pre-covid duration. Currently, time to surgery in our hospital is approximately 7 months as opposed to 2-3 months pre-covid.

Long wait times may be a substantial burden for patients. There have been reports of worsening pain, deterioration in quality of life and increased opioid use and frailty. The effects on pain catastrophizing, fear and anxiety have not yet been studied.

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

  • on the waiting list for partial or total knee arthroplasty
  • written informed consent

排除标准

  • 未提供

结局指标

主要结局

Knee function measured with the Oxford knee score (OKS)

时间窗: Baseline, before surgery

This questionnaire consists of 12 items, which are divided into disease-specific and generic questions. Scores can range from 0 - 48, lower scores indicate more functional limitations and pain.

次要结局

  • numeric rating scale for pain (NRS)(baseline, before surgery, 6 and 12 months postoperatively)
  • Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L)(baseline, before surgery, 6 and 12 months postoperatively)
  • Hospital anxiety and depression scale (HADS)(baseline, before surgery, 6 and 12 months postoperatively)
  • Pain catastrophizing scale (PCS)(baseline, before surgery, 6 and 12 months postoperatively)

研究者

发起方
Dijklander Ziekenhuis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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