Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty

NCT05510947 | Completed

• 1 other identifier: UKAPCS
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmission, and lower costs. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). These HPR-patients constitute a vulnerable high risk patient group and potentially benefit from targeted treatment. Currently, the distribution of HPR- and LPR-patients and their association with acute pain following UKA is not well investigated. The knowledge that this research project generates is essential to determine how studies with analgesia interventions should be designed. In the future this will contribute in targeting treatment for high risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided. The aim of this study is to investigate the prevalence of high- and low-pain responders, defined by a PCS score \> 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.

Conditions

Post Operative Pain

Keywords

Acute Postoperative Pain; Unicompartmental Knee Arthroplasty; Pain catastrophizing scale

Outcome Measures

Primary Outcomes (1)

• Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively

  Preoperatively

Secondary Outcomes (2)

• Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in LPR patients

  24 hours

• Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in HPR patients

  24 hours

Other Outcomes (6)

• Difference between HPR:LPR patients in incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively

  24 hours

• Difference between HPR:LPR patients in incidence of moderate to severe pain (VAS > 30 mm) at rest 24 hours postoperatively

  24 hours

• Difference between HPR:LPR patients in cumulated pain upon ambulation in a 5-meter walk test day 2-7

  Day 2-7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients planned for unicompartmental knee arthroplasty at a Danish hospital.

You may qualify if:

• Primary unilateral UKA
• Age ≥ 18 years
• Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
• Filled out the Pain Catastrophizing Scale preoperatively.
• Signed written informed consent form.

You may not qualify if:

• Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
• Insulin-treated diabetes mellitus
• Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
• Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
• Peripheral nerve block per- or postoperatively.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (17)

• Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.

  PMID: 31326135 BACKGROUND

• Birch S, Stilling M, Mechlenburg I, Hansen TB. The association between pain catastrophizing, physical function and pain in a cohort of patients undergoing knee arthroplasty. BMC Musculoskelet Disord. 2019 Sep 12;20(1):421. doi: 10.1186/s12891-019-2787-6.

  PMID: 31511076 BACKGROUND

• Hansen EN, Ong KL, Lau E, Kurtz SM, Lonner JH. Unicondylar Knee Arthroplasty Has Fewer Complications but Higher Revision Rates Than Total Knee Arthroplasty in a Study of Large United States Databases. J Arthroplasty. 2019 Aug;34(8):1617-1625. doi: 10.1016/j.arth.2019.04.004. Epub 2019 Apr 8.

  PMID: 31064725 BACKGROUND

• Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.

  PMID: 28801208 BACKGROUND

• Jensen CB, Petersen PB, Jorgensen CC, Kehlet H, Troelsen A, Gromov K; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Length of Stay and 90-Day Readmission/Complication Rates in Unicompartmental Versus Total Knee Arthroplasty: A Propensity-Score-Matched Study of 10,494 Procedures Performed in a Fast-Track Setup. J Bone Joint Surg Am. 2021 Jun 16;103(12):1063-1071. doi: 10.2106/JBJS.20.01287.

  PMID: 33784260 BACKGROUND

• Jensen CB, Troelsen A, Nielsen CS, Otte NKS, Husted H, Gromov K. Why are patients still in hospital after fast-track, unilateral unicompartmental knee arthroplasty. Acta Orthop. 2020 Aug;91(4):433-438. doi: 10.1080/17453674.2020.1751952. Epub 2020 Apr 14.

  PMID: 32285727 BACKGROUND

• Kim MS, Koh IJ, Choi YJ, Lee JY, In Y. Differences in Patient-Reported Outcomes Between Unicompartmental and Total Knee Arthroplasties: A Propensity Score-Matched Analysis. J Arthroplasty. 2017 May;32(5):1453-1459. doi: 10.1016/j.arth.2016.11.034. Epub 2016 Nov 27.

  PMID: 27979407 BACKGROUND

• Liddle AD, Pandit H, Judge A, Murray DW. Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14,076 matched patients from the National Joint Registry for England and Wales. Bone Joint J. 2015 Jun;97-B(6):793-801. doi: 10.1302/0301-620X.97B6.35155.

  PMID: 26033059 BACKGROUND

• Lunn TH, Frokjaer VG, Hansen TB, Kristensen PW, Lind T, Kehlet H. Analgesic effect of perioperative escitalopram in high pain catastrophizing patients after total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2015 Apr;122(4):884-94. doi: 10.1097/ALN.0000000000000597.

  PMID: 25782644 BACKGROUND

• Lunn TH, Gaarn-Larsen L, Kehlet H. Prediction of postoperative pain by preoperative pain response to heat stimulation in total knee arthroplasty. Pain. 2013 Sep;154(9):1878-1885. doi: 10.1016/j.pain.2013.06.008. Epub 2013 Jun 12.

  PMID: 23769717 BACKGROUND

• Nemes S, Rolfson O, W-Dahl A, Garellick G, Sundberg M, Karrholm J, Robertsson O. Historical view and future demand for knee arthroplasty in Sweden. Acta Orthop. 2015;86(4):426-31. doi: 10.3109/17453674.2015.1034608. Epub 2015 Mar 25.

  PMID: 25806653 BACKGROUND

• Ode Q, Gaillard R, Batailler C, Herry Y, Neyret P, Servien E, Lustig S. Fewer complications after UKA than TKA in patients over 85 years of age: A case-control study. Orthop Traumatol Surg Res. 2018 Nov;104(7):955-959. doi: 10.1016/j.otsr.2018.02.015. Epub 2018 Apr 21.

  PMID: 29684539 BACKGROUND

• Otero JE, Gholson JJ, Pugely AJ, Gao Y, Bedard NA, Callaghan JJ. Length of Hospitalization After Joint Arthroplasty: Does Early Discharge Affect Complications and Readmission Rates? J Arthroplasty. 2016 Dec;31(12):2714-2725. doi: 10.1016/j.arth.2016.07.026. Epub 2016 Aug 9.

  PMID: 27600301 BACKGROUND

• Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.

  PMID: 15599135 BACKGROUND

• Pinto PR, McIntyre T, Ferrero R, Almeida A, Araujo-Soares V. Predictors of acute postsurgical pain and anxiety following primary total hip and knee arthroplasty. J Pain. 2013 May;14(5):502-15. doi: 10.1016/j.jpain.2012.12.020. Epub 2013 Mar 27.

  PMID: 23541065 BACKGROUND

• Wilson HA, Middleton R, Abram SGF, Smith S, Alvand A, Jackson WF, Bottomley N, Hopewell S, Price AJ. Patient relevant outcomes of unicompartmental versus total knee replacement: systematic review and meta-analysis. BMJ. 2019 Feb 21;364:l352. doi: 10.1136/bmj.l352.

  PMID: 30792179 BACKGROUND

• Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High-dose steroids in high pain responders undergoing total knee arthroplasty: a randomised double-blind trial. Br J Anaesth. 2022 Jan;128(1):150-158. doi: 10.1016/j.bja.2021.10.001. Epub 2021 Nov 5.

  PMID: 34749994 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nicolai B Foss, MD, dr.med.

  Department of Anaesthesiology, Copenhagen University Hospital Hvidovre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion: September 27, 2023
• Study Completion: October 4, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available from the date of publication.

Locations

DK (1)