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Early Cognitive Changes After Same-day Discharge Hip and Knee Arthroplasty

2026年6月17日 更新者:Abdullahi Abdirisak Hirsi、Odense University Hospital

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

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

調査の概要

詳細な説明

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

The cognitive tests:

The cognitive tests will be administered by research assistants with prior research experience.

Eligible participants will be recruited from the outpatient clinic. Testing will be performed virtually with the patients being at home. The patients will receive instructions to complete all sessions in the same quiet room and on the same device, to keep environmental stimuli (lighting, background noise, screen distance, seating, posture, and internet conditions) constant and thereby reduce within-subject variance and practice effects. The baseline test will be administered 14 days +- 3 days prior to surgery to avoid preoperative anxiety effects. Postoperatively, testing will be carried out on postoperative day 1 and day 7. More frequent testing is avoided to reduce practice effects.

Only patients receiving spinal anesthesia will be included to minimize confounding from general anesthesia and to reflect current fast-track practice. Spinal anesthesia is administered using a relatively short-acting blockade bupivacaine 5 mg/mL, 2.5 mL (12.5 mg) in THA, while for primary TKA and UKA, bupivacaine 5 mg/mL, 2 mL (10 mg) . Standard local infiltration analgesia (LIA) will be used with 150 mL ropivacaine 2 mg/mL in knee arthroplasties but not in hip arthroplasties . Peripheral nerve blocks are not used. Patients will also receive cloxacillin 2 gr, methylprednisolone 125 mg and 1 gr tranexamic acid intravenously immediately prior to skin incision.

Postoperative pain management and other medication Postoperative pain management will follow a standardized multimodal, opioid-sparing regimen. All patients will receive paracetamol (1 g × 4) in combination with ibuprofen 400 mg × 3 (7 days) for THA patients in and 400 mg × 4 (14 days) for TKA and UKA patients, unless contraindicated.

Opioids will be reserved as rescue medication, administered only on an "as needed" basis. Morphine 10 mg tablets will be used as first-line rescue analgesia, with oxycodone 5 mg as an alternative for patients who do not tolerate morphine.

Data Source:

A REDCap database has been established in collaboration with the Open Patient Data Explorative Network (OPEN) at Odense University Hospital (25). Patients scheduled for hip and knee arthroplasty at Svendborg hospital and included in the planned study will be enrolled in the database following informed consent. Patient's baseline database will be registered on comorbidities and medication use entered by trained research staff.

Statistics and sample size Although this is an exploratory study, the sample size was guided by considerations from both the literature and our pilot planning. Because the design is paired, each participant serves as their own control (baseline vs. postoperative assessment). For the SDMT we assumed a minimal clinically important difference (MCID) of 4 points , a within-subject correlation of 0.85 between baseline and postoperative scores, and a standard deviation of 7.5 . With a two-sided alpha of 0.05 and 80% power, this corresponds to approximately 14 participants with complete paired measurements per subgroup (THA, TKA, and UKA) if analyses are performed separately. To account for anticipated dropout/non-same-day discharge, we will aim to enroll 16 patients per subgroup to obtain 14 participants with complete paired measurements.

Continuous variables will be summarized as mean with standard deviation (SD) and range if approximately normally distributed; otherwise as median with interquartile range (IQR) and range. Categorical variables will be described using absolute and relative frequencies (n, %).

Patient involvement Patients who have previously undergone hip or knee arthroplasty were involved in the design process. Their feedback informed the research questions and outcome measures, ensuring relevance and patient-centeredness. During pilot testing, participating patients also provided input on the planned assessment procedures and overall feasibility, which further informed methodological adjustments.

研究の種類

観察的

入学 (推定)

48

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Svendborg、デンマーク、5700
        • 募集
        • Odense University Hospital, Svendborg Hospital
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Abdullahi Abdirisak Hirsi, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Patients scheduled for hip or knee arthroplasty at Svendborg hospital, Denmark.

説明

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Symbol Digit Modalities Test (SDMT) score from baseline to postoperative day 1.
時間枠: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
From baseline, 14 days before surgery, and postoperative day 1.

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Stroop Color-Word Test score from baseline to postoperative day 1.
時間枠:From baseline, 14 days before surgery, and postoperative day 1.
The Stroop Color-Word Test is a validated measure of selective attention and susceptibility to interference. The primary metrics will be completion time (seconds) and number of errors recorded for each session.
From baseline, 14 days before surgery, and postoperative day 1.
Change in Stroop Color-Word Test score from baseline to postoperative day 7.
時間枠:From baseline, 14 days before surgery, and postoperative day 7.
The Stroop Color-Word Test is a validated measure of selective attention and susceptibility to interference. The primary metrics will be completion time (seconds) and number of errors recorded for each session.
From baseline, 14 days before surgery, and postoperative day 7.
Change in Verbal fluency assessment score from baseline to postoperative day 1.
時間枠:From baseline, 14 days before surgery, and postoperative day 1.
Verbal fluency assessment is a validated test which assesses executive function, semantic memory, and language. In our test a semantic (animal naming) and a phonemic (letter S) fluency task were used, each administered for 60 seconds. Number of correct responses for each task will be registered.
From baseline, 14 days before surgery, and postoperative day 1.
Reporting patient-reported cognitive function on postoperative day 1.
時間枠:Postoperative day 1.
A brief two-item subjective cognitive questionnaire will be administered to assess patient's perceived cognitive changes and to identify any discrepancy between subjective experience and objective neuropsychological test performance.
Postoperative day 1.
Change in Symbol Digit Modalities Test (SDMT) score from baseline to postoperative day 7.
時間枠:From baseline, 14 days before surgery, and postoperative day 7.
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
From baseline, 14 days before surgery, and postoperative day 7.
Change in Verbal fluency assessment score from baseline to postoperative day 7.
時間枠:From baseline, 14 days before surgery, and postoperative day 7.
Verbal fluency assessment is a validated test which assesses executive function, semantic memory, and language. In our test a semantic (animal naming) and a phonemic (letter S) fluency task were used, each administered for 60 seconds. Number of correct responses for each task will be registered.
From baseline, 14 days before surgery, and postoperative day 7.
Change in patient-reported cognitive function from postoperative day 1 to postoperative day 7.
時間枠:From postoperative day 1 and postoperative day 7.
A brief two-item subjective cognitive questionnaire will be administered to assess patient's perceived cognitive changes and to identify any discrepancy between subjective experience and objective neuropsychological test performance.
From postoperative day 1 and postoperative day 7.

その他の成果指標

結果測定
メジャーの説明
時間枠
Cumulative In-hospital postoperative morphine consumption
時間枠:End of surgery until discharge from the hospital on the day 1 of surgery (DOS)
Measured in milligrams
End of surgery until discharge from the hospital on the day 1 of surgery (DOS)
Postoperative pain intensity during rest once a day.
時間枠:From postoperative day 1 to postoperative day 7.
Patients will record pain intensity using an 11-point numeric rating scale (NRS, 0-10) in a pain diary.
From postoperative day 1 to postoperative day 7.
Postoperative pain intensity during activity once a day
時間枠:From postoperative day 1 to postoperative day 7.
Patients will record pain intensity using an 11-point numeric rating scale (NRS, 0-10) in a pain diary. Pain will be assessed defined as a standardized 5-m walk test.
From postoperative day 1 to postoperative day 7.
Cumulative postoperative morphine consumption
時間枠:Postoperative day 1 to postoperative day 7.
Measured in milligrams.
Postoperative day 1 to postoperative day 7.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Martin Lindberg-Larsen, Professor、Head of Research / Consultant Orthopaedic Surgeon at Odense University Hospital. Department of Clinical Research, University of Southern Denmark (SDU)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月18日

一次修了 (推定)

2026年10月31日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年5月14日

QC基準を満たした最初の提出物

2026年5月19日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be publicly shared due to Danish data protection regulations and the nature of the clinical dataset. De-identified data may be made available from the investigators upon reasonable request and subject to applicable approvals.

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米国FDA規制機器製品の研究

いいえ

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