NCT07598552

Brief Summary

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 batteri vitually 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Nov 2026

First Submitted

Initial submission to the registry

May 14, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 14, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Same-day dischargeFast-track surgeryHip arthroplastyKnee arthroplastyUnicompartmental knee arthroplastyCognitive functionSDMTStroop testVerbal fluencyOlder adultsrecovery

Outcome Measures

Primary Outcomes (1)

  • Change in Symbol Digit Modality Test (SDMT) score from baseline to 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.

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Other Outcomes (4)

  • Cumulative In-hospital postoperative morphine consumption

    End of surgery until discharge from the hospital on the day 1 of surgery (DOS)

  • Cumulated postoperative morphine consumption.

    Postoperative day 1 to postoperative day 7.

  • Postoperative pain intensity during rest once a day.

    From postoperative day 1 to postoperative day 7.

  • +1 more other outcomes

Study Arms (3)

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.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital, Svendborg Hospital

Svendborg, 5700, Denmark

Location

Related Publications (23)

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    PMID: 34923428BACKGROUND
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    PMID: 18929686BACKGROUND
  • Springborg AH, Jensen CB, Gromov K, Troelsen A, Kehlet H, Foss NB. Acute postoperative pain and catastrophizing in unicompartmental knee arthroplasty: a prospective, observational, single-center, cohort study. Reg Anesth Pain Med. 2025 Sep 4;50(9):706-711. doi: 10.1136/rapm-2024-105503.

    PMID: 38839429BACKGROUND
  • Ahmed MT, Troyas C, Daramola AM, Isik OG, Cassim TZ, Goldberg TE, Banerji A, Sleigh J, Garcia PS. Characterization of Speech and Language Deficits in the Postanesthesia Care Unit: A Novel, Qualitative Cognitive Assessment. Anesth Analg. 2025 Mar 1;140(3):655-664. doi: 10.1213/ANE.0000000000006940. Epub 2024 Mar 25.

    PMID: 39976622BACKGROUND
  • Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.

    PMID: 24939863BACKGROUND
  • Pu X, Sun JM. General anesthesia vs spinal anesthesia for patients undergoing total-hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2019 Apr;98(16):e14925. doi: 10.1097/MD.0000000000014925.

    PMID: 31008923BACKGROUND
  • Jorgensen K, Nielsen TR, Nielsen A, Oxboll AB, Gerner SD, Waldorff FB, Waldemar G. Diagnostic accuracy of the Brief Assessment of Impaired Cognition case-finding instrument in a general practice setting and comparison with other widely used brief cognitive tests-a cross-validation study. Eur J Neurol. 2024 Oct;31(10):e16418. doi: 10.1111/ene.16418. Epub 2024 Jul 24.

    PMID: 39045891BACKGROUND
  • Marceaux JC, Prosje MA, McClure LA, Kana B, Crowe M, Kissela B, Manly J, Howard G, Tam JW, Unverzagt FW, Wadley VG. Verbal fluency in a national sample: Telephone administration methods. Int J Geriatr Psychiatry. 2019 Apr;34(4):578-587. doi: 10.1002/gps.5054. Epub 2019 Jan 18.

    PMID: 30588700BACKGROUND
  • Joffe Y, Liu J, Arias F, Tommet D, Fong TG, Schmitt EM, Travison T, Kunicki ZJ, Inouye SK, Jones RN. Adaptation, calibration, and validation of a cognitive assessment battery for telephone and video administration. J Am Geriatr Soc. 2025 Feb;73(2):482-491. doi: 10.1111/jgs.19275. Epub 2024 Nov 21.

    PMID: 39569941BACKGROUND
  • Chapman JE, Helmstaedter C, Abbott DF, Pardoe HR, Vaughan DN, Jackson GD, Tailby C; Australian Epilepsy Project Investigators. Videoconference-integrated, computer-assisted cognitive testing improves the remote assessment of processing speed and attention. J Int Neuropsychol Soc. 2025 Aug;31(7-8):582-591. doi: 10.1017/S1355617725101124. Epub 2025 Oct 22.

    PMID: 41122074BACKGROUND
  • Contino V, Abrams JH, Arumugam S, Sinha SK, Vellanky SS, Cremins MS, McCann GP. Spinal Anesthesia Using Ropivacaine Leads to Earlier Ambulation After Total Hip Arthroplasty. Orthopedics. 2021 May-Jun;44(3):e343-e346. doi: 10.3928/01477447-20210414-04. Epub 2021 May 1.

    PMID: 34039195BACKGROUND
  • Lindberg-Larsen M, Varnum C, Jakobsen T, Andersen MR, Sperling K, Overgaard S, Hansen TB, Jorgensen CC, Kehlet H, Gromov K. Study protocol for discharge on day of surgery after hip and knee arthroplasty from the Center for Fast-track Hip and Knee Replacement. Acta Orthop. 2023 Mar 20;94:121-127. doi: 10.2340/17453674.2023.11636.

    PMID: 36942664BACKGROUND
  • Kehlet H, Lobo DN. Exploring the need for reconsideration of trial design in perioperative outcomes research: a narrative review. EClinicalMedicine. 2024 Feb 29;70:102510. doi: 10.1016/j.eclinm.2024.102510. eCollection 2024 Apr.

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  • Joshi GP, Alexander JC, Kehlet H. Large pragmatic randomised controlled trials in peri-operative decision making: are they really the gold standard? Anaesthesia. 2018 Jul;73(7):799-803. doi: 10.1111/anae.14238. Epub 2018 Mar 25. No abstract available.

    PMID: 29577228BACKGROUND
  • Vogel A, Stokholm J, Jorgensen K. Performances on Symbol Digit Modalities Test, Color Trails Test, and modified Stroop test in a healthy, elderly Danish sample. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2013;20(3):370-82. doi: 10.1080/13825585.2012.725126. Epub 2012 Sep 27.

    PMID: 23013462BACKGROUND
  • Zhang Q, Chen Y, Li Y, Liu R, Rai S, Li J, Hong P. Enhanced recovery after surgery in patients after hip and knee arthroplasty: a systematic review and meta-analysis. Postgrad Med J. 2024 Feb 15;100(1181):159-173. doi: 10.1093/postmj/qgad125.

    PMID: 38134323BACKGROUND
  • Krenk L, Jennum P, Kehlet H. Activity, sleep and cognition after fast-track hip or knee arthroplasty. J Arthroplasty. 2013 Sep;28(8):1265-9. doi: 10.1016/j.arth.2013.02.013. Epub 2013 Mar 28.

    PMID: 23541866BACKGROUND
  • Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.

    PMID: 22831887BACKGROUND
  • Krenk L, Rasmussen LS, Hansen TB, Bogo S, Soballe K, Kehlet H. Delirium after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Apr;108(4):607-11. doi: 10.1093/bja/aer493. Epub 2012 Jan 24.

    PMID: 22277666BACKGROUND
  • Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.

    PMID: 37599617BACKGROUND
  • Joris J, Kehlet H, Slim K. Postoperative cognitive dysfunction: time for enhanced recovery after surgery programmes. Eur J Anaesthesiol. 2022 Sep 1;39(9):733-734. doi: 10.1097/EJA.0000000000001684. No abstract available.

    PMID: 35919025BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Martin Lindberg-Larsen, Professor

    Head of Research / Consultant Orthopaedic Surgeon at Odense University Hospital. Department of Clinical Research, University of Southern Denmark (SDU)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullahi Abdirisak Hirsi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 20, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations