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临床试验/NCT07598552
NCT07598552招募中不适用

Early Cognitive Changes in Patients Aged 70 Years or Older After Same-day Discharge Hip and Knee Arthroplasty: A Prospective Cohort Study

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Change in Symbol Digit Modality Test (SDMT) score from baseline to postoperative day 1.

研究概览

简要总结

The goal of this observational study is to explore early cognitive changes in patients aged 70 years or older undergoing same-day discharge after hip or knee replacement surgery. The main question it aims to answer is:

Does patients experience cognitive changes in cognitive test performance from before surgery to the first day after surgery?

Participants will:

  • Complete a cognitive test battery virtually about 14 days before surgery, and on the first and seventh day after their operation.
  • Record pain levels and pain medicine use during the first week after surgery

详细描述

Introduction Background Postoperative cognitive dysfunction (POCD) is a prevalent complication in elderly patients and has significant clinical and socioeconomic consequences, delayed recovery, decreased quality of life, persistent neurocognitive disorders and increased morbidity and mortality within the first year of surgery . The pathogenesis remains poorly understood, partly due to varying diagnostic approaches and methodologies. Nevertheless, there is consensus that POCD is multifactorial influenced by factors such as advanced age, sleep disturbances, and inadequate perioperative pain management .

Sleep deprivation, in particular, can exacerbate hyperalgesia, impair cognition, and lead to increased respiratory and cardiac risks due to REM sleep rebound. Fast-track surgical protocols, which emphasize multimodal rehabilitation-including regional anesthesia, opioid-sparing analgesia, and early mobilization-have been shown to reduce postoperative pain, sleep disturbances, and the risk of delirium. These protocols have reduced the average length of hospital stays worldwide. In Denmark length of hospital stay after total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee (UKA) is now only one day and an increasing number of patients are discharged on the day of surgery. Same-day discharge enable earlier return to a familiar environment and potentially enhanced pathophysiological recovery.

No studies have described early postoperative cognitive test performance in elderly patients undergoing same-day discharge hip and knee arthroplasty. This study therefore aims to address this knowledge gap by examining early cognitive changes in patients aged ≥70 years after same-day discharge hip and knee arthroplasty.

Aim The primary aim of this study is to report early cognitive changes measured with Symbol Digit Modality Test (SDMT) in patients over 70 years undergoing same-day discharge THA, TKA and UKA. Secondary, to report cognitive changes using the Stroop Color Test and verbal fluency test as well as patient's perceived cognitive function. As patients return home on the day of surgery in this contemporary same-day discharge arthroplasty setting, we hypothesize that early postoperative changes in cognitive performance will be limited compared with earlier fast-track studies with a longer median length of stay (LOS).

Methods

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral elective primary Total Hip Arthroplasty, Total Knee Arthroplasty, or Unicompartmental Knee
  • Native Danish speaker
  • Spinal anesthesia

排除标准

  • Inability or unwillingness to provide informed consent
  • Inability to comply with virtual study procedures or follow-up sessions, including because of visual or hearing impairment
  • Known dementia or other diagnosed cognitive disorders or Brief Assessment of Impaired Cognition (BASIC)≤20
  • Parkinson's disease or other neurological conditions causing functional impairment
  • History of alcohol abuse (≥35 units per week)
  • Daily use of anxiolytics or hypnotics
  • Not discharged on the day of surgery

研究组 & 干预措施

Total Hip Arthroplasty

Patients aged 70 years or older undergoing elective unilateral total hip arthroplasty with planned discharge on the day of surgery.

Total Knee Arthroplasty

Patients aged 70 years or older undergoing elective unilateral total knee arthroplasty with planned discharge on the day of surgery.

Unicompartmental Knee Arthroplasty

Patients aged 70 years or older undergoing elective unilateral unicompartmental knee arthroplasty with planned discharge on the day of surgery.

结局指标

主要结局

Change in Symbol Digit Modality Test (SDMT) score from baseline to postoperative day 1.

时间窗: From baseline, 14 days before surgery, and postoperative day 1.

The SDMT is a validated neuropsychological tool that measures processing speed, attention, and visual scanning. The SDMT will be administered virtually as an oral 90-second test. The primary metric will be the SDMT score, defined as the number of correct digit substitutions completed within 90 seconds

Change in Symbol Digit Modalities Test (SDMT) score from baseline to postoperative day 1.

时间窗: From baseline, 14 days before surgery, and postoperative day 1.

The SDMT is a validated neuropsychological tool that measures processing speed, attention, and visual scanning. The SDMT will be administered virtually as an oral 90-second test. The primary metric will be the SDMT score, defined as the number of correct digit substitutions completed within 90 seconds

次要结局

  • Change in Symbol Digit Modality Test (SDMT) score from baseline to postoperative day 7.(From baseline, 14 days before surgery, and postoperative day 7.)
  • Change in Stroop Color-Word Test score from baseline to postoperative day 1.(From baseline, 14 days before surgery, and postoperative day 1.)
  • Change in Stroop Color-Word Test score from baseline to postoperative day 7.(From baseline, 14 days before surgery, and postoperative day 7.)
  • Change in Verbal fluency assessment score from baseline to postoperative day 1.(From baseline, 14 days before surgery, and postoperative day 1.)
  • Change in Verbal fluency assessment score from baseline to postoperative day 7.(From baseline, 14 days before surgery, and postoperative day 1.)
  • Reporting patient-reported cognitive function on postoperative day 1.(Postoperative day 1.)
  • Change in patient-reported cognitive function from postoperatve day 1 to postoperative day 7.(From postoperative day 1 and postoperative day 7.)
  • Change in Symbol Digit Modalities Test (SDMT) score from baseline to postoperative day 7.(From baseline, 14 days before surgery, and postoperative day 7.)
  • Change in Verbal fluency assessment score from baseline to postoperative day 7.(From baseline, 14 days before surgery, and postoperative day 7.)
  • Change in patient-reported cognitive function from postoperative day 1 to postoperative day 7.(From postoperative day 1 and postoperative day 7.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdullahi Abdirisak Hirsi

Medical doctor

Odense University Hospital

研究点 (1)

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