Are Perception of Pain and Psychological Distress Before Knee Arthroplasty Associated With Reason for Revision?
NCT ID: NCT05105646
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70754 participants
OBSERVATIONAL
2014-01-01
2019-12-31
Brief Summary
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Detailed Description
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It is known that 1 in 5 patients rate themselves categorically dissatisfied after knee arthroplasty (the so-called unhappy knee). It seems sensible that the percentage of patients that has some dissatisfaction with their knee arthroplasty is likely much larger. After knee arthroplasty, some patients receive revision surgery based on clear reasons such as periprosthetic fracture and patellar dislocation, while in some patients that are dissatisfied revision surgery might be considered for less clear reasons such as a small technical issue, for a perceived technical issue, or with the idea that there is a low grade infection. Understanding the preoperative factors of postoperative pain and functional impairment, leading to dissatisfaction, may help to inform patients considering primary knee arthroplasty about the risk of revision surgery. Although pain and function of patients with higher preoperative pain scores before primary knee arthroplasty will improve as much as the scores of patients with lower preoperative pain scores, their final postoperative pain levels and function will remain inferior compared to patients with lower preoperative pain scores. Higher levels of anxiety and symptoms of depression before knee arthroplasty have also been related to worse postoperative patient reported outcome measures after surgery. Furthermore, the experience of pain and symptoms of depression are closely related to each other and they may influence each other in a bidirectional way. Determining the influence of preoperative pain and psychological distress (anxiety/depression) and their interaction on postoperative outcome seems to be crucial because mental and social health opportunities might be underdiagnosed and undertreated and the indication for a revision surgery may be based on a misdiagnosis of perceived or actual pathophysiology or technical deficiency in patients without a clear technical or medical indication for revision.
The aim of this study is to identify the influence of the preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their association before primary total knee arthroplasty (TKA) on revision surgery for unexplained symptoms after primary surgery.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients
• All patients undergoing primary total knee arthroplasty for osteoarthritis of the knee reported in the Dutch Arthroplasty Register.
and
• Patients who filled out the EQ-5D-3L anxiety/depression score.
Knee Arthroplasty, knee revision arthoplasty
Primary knee arthroplasty (e.g., total, unicondylar and patellofemoral)
Interventions
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Knee Arthroplasty, knee revision arthoplasty
Primary knee arthroplasty (e.g., total, unicondylar and patellofemoral)
Eligibility Criteria
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Inclusion Criteria
* Patients who filled out the NRS pain score, EQ-5D 3L or EQ-5D 5L pain score or EQ-5D anxiety/depression score.
Exclusion Criteria
* Patients who did not fill out the NRS pain score, EQ-5D (3L or 5L) pain score or EQ-5D (3L or 5L) anxiety/depression score
18 Years
ALL
Yes
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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rwpoolman
Professor Rudolf Wilhelm Poolman
Principal Investigators
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Rudolf Poolman, Prof
Role: PRINCIPAL_INVESTIGATOR
LUMC
Locations
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LUMC
Leiden, , Netherlands
Countries
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References
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Spekenbrink-Spooren A, Van Steenbergen LN, Denissen GAW, Swierstra BA, Poolman RW, Nelissen RGHH. Higher mid-term revision rates of posterior stabilized compared with cruciate retaining total knee arthroplasties: 133,841 cemented arthroplasties for osteoarthritis in the Netherlands in 2007-2016. Acta Orthop. 2018 Dec;89(6):640-645. doi: 10.1080/17453674.2018.1518570. Epub 2018 Oct 23.
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Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
Ferket BS, Feldman Z, Zhou J, Oei EH, Bierma-Zeinstra SM, Mazumdar M. Impact of total knee replacement practice: cost effectiveness analysis of data from the Osteoarthritis Initiative. BMJ. 2017 Mar 28;356:j1131. doi: 10.1136/bmj.j1131.
Tolk JJ, Waarsing JEH, Janssen RPA, van Steenbergen LN, Bierma-Zeinstra SMA, Reijman M. Development of Preoperative Prediction Models for Pain and Functional Outcome After Total Knee Arthroplasty Using The Dutch Arthroplasty Register Data. J Arthroplasty. 2020 Mar;35(3):690-698.e2. doi: 10.1016/j.arth.2019.10.010. Epub 2019 Oct 18.
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Duivenvoorden T, Vissers MM, Verhaar JA, Busschbach JJ, Gosens T, Bloem RM, Bierma-Zeinstra SM, Reijman M. Anxiety and depressive symptoms before and after total hip and knee arthroplasty: a prospective multicentre study. Osteoarthritis Cartilage. 2013 Dec;21(12):1834-40. doi: 10.1016/j.joca.2013.08.022. Epub 2013 Sep 4.
Ellis HB, Howard KJ, Khaleel MA, Bucholz R. Effect of psychopathology on patient-perceived outcomes of total knee arthroplasty within an indigent population. J Bone Joint Surg Am. 2012 Jun 20;94(12):e84. doi: 10.2106/JBJS.K.00888.
Konig HH, Born A, Gunther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C. Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes. 2010 May 5;8:47. doi: 10.1186/1477-7525-8-47.
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Geisser ME, Roth RS, Theisen ME, Robinson ME, Riley JL 3rd. Negative affect, self-report of depressive symptoms, and clinical depression: relation to the experience of chronic pain. Clin J Pain. 2000 Jun;16(2):110-20. doi: 10.1097/00002508-200006000-00004.
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Riddle DL, Jiranek WA, Hayes CW. Use of a validated algorithm to judge the appropriateness of total knee arthroplasty in the United States: a multicenter longitudinal cohort study. Arthritis Rheumatol. 2014 Aug;66(8):2134-43. doi: 10.1002/art.38685.
Related Links
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Reference 2 LROI 2019. LROI Report 2019 \[Internet\]. \[cited 2020 Feb 11\].
Other Identifiers
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W.20.018)
Identifier Type: -
Identifier Source: org_study_id