Clinical trial NCT05105646: Are Perception of Pain and Psychological Distress Before Knee Arthroplasty Associated With Reason for Revision?
Official title: Are Preoperative Perception of Pain and Psychological Distress Before Primary Knee Arthroplasty Associated With Reason for Revision Surgery? Results of an Observational Study From the Dutch Arthroplasty Register.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteo Arthritis Knee
Psychological Distress
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 70754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.

Brief summary: The aim of our study is to identify the influence of preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their interaction before primary total knee arthroplasty on revision surgery for unexplained symptoms after primary surgery.

Detailed description: Knee arthroplasty can decrease pain and improve function in people with advanced osteoarthritis of the knee. It is a common procedure; over 25,000 primary knee arthroplasties are performed in the Netherlands each year\[2\]. A primary knee arthroplasty is defined as the first implantation of a prosthesis in the knee. Revision surgery is defined as any exchange (placement, replacement, or removal) or addition of 1 or more components of the prosthesis (e.g. patella resurfacing)\[3\]. About 12% of knee arthroplasties are revised within 10 years.

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.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.
* 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:

* Other types of (revision) arthroplasty (hip / shoulder / ankle)
* 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

Primary outcomes:
measure: Revision surgery after knee arthroplasty
timeFrame: Duration until surgery, an average of 2.05 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
affiliation: LUMC
name: Rudolf Poolman, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
citation: 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.
citation: Labek G, Thaler M, Janda W, Agreiter M, Stockl B. Revision rates after total joint replacement: cumulative results from worldwide joint register datasets. J Bone Joint Surg Br. 2011 Mar;93(3):293-7. doi: 10.1302/0301-620X.93B3.25467.
citation: 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.
citation: 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.
citation: 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.
citation: Choi YJ, Ra HJ. Patient Satisfaction after Total Knee Arthroplasty. Knee Surg Relat Res. 2016 Mar;28(1):1-15. doi: 10.5792/ksrr.2016.28.1.1. Epub 2016 Feb 29.
citation: van de Water RB, Leichtenberg CS, Nelissen RGHH, Kroon HM, Kaptijn HH, Onstenk R, Verdegaal SHM, Vliet Vlieland TPM, Gademan MGJ. Preoperative Radiographic Osteoarthritis Severity Modifies the Effect of Preoperative Pain on Pain/Function After Total Knee Arthroplasty: Results at 1 and 2 Years Postoperatively. J Bone Joint Surg Am. 2019 May 15;101(10):879-887. doi: 10.2106/JBJS.18.00642.
citation: Bierke S, Haner M, Petersen W. Influence of somatization and depressive symptoms on the course of pain within the first year after uncomplicated total knee replacement: a prospective study. Int Orthop. 2016 Jul;40(7):1353-60. doi: 10.1007/s00264-015-3105-z. Epub 2016 Jan 28.
citation: Bistolfi A, Bettoni E, Aprato A, Milani P, Berchialla P, Graziano E, Massazza G, Lee GC. The presence and influence of mild depressive symptoms on post-operative pain perception following primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2792-2800. doi: 10.1007/s00167-015-3737-y. Epub 2015 Sep 21.
citation: 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.
citation: 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.
citation: 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.
citation: Khatib Y, Jenkin D, Naylor JM, Harris IA. Psychological Traits in Patients Waiting for Total Knee Arthroplasty. A Cross-sectional Study. J Arthroplasty. 2016 Aug;31(8):1661-6. doi: 10.1016/j.arth.2016.01.053. Epub 2016 Feb 8.
citation: 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.
citation: Papakostidou I, Dailiana ZH, Papapolychroniou T, Liaropoulos L, Zintzaras E, Karachalios TS, Malizos KN. Factors affecting the quality of life after total knee arthroplasties: a prospective study. BMC Musculoskelet Disord. 2012 Jun 29;13:116. doi: 10.1186/1471-2474-13-116.
citation: 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.