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Are Perception of Pain and Psychological Distress Before Knee Arthroplasty Associated With Reason for Revision?

24. oktober 2021 opdateret af: rwpoolman, Leiden University Medical Center

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.

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

70754

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Leiden, Holland, 2333 ZA
        • LUMC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Primary knee arthroplasty (e.g., total, unicondylar and patellofemoral)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Revision surgery after knee arthroplasty
Tidsramme: Duration until surgery, an average of 2.05 years.

Our primary outcome measure was if a patient received revision surgery after knee arthroplasty (yes/no).

We categorized the reason for revision in a consensus meeting among the investigators from this research group and experts in the Orthopaedic Surgery field into the following categories:

  • Clear reason for revision (patellar dislocation, insert wear, fracture, loosening and second stage revision after removal of knee arthroplasty)
  • Less clear reason for revision (infection, malalignment and instability)
  • Revision performed for unexplained symptoms without important pathophysiology (patellar pain, arthrofibrosis or progression of osteoarthritis (in case of unicondylar knee arthroplasty)).
Duration until surgery, an average of 2.05 years.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Rudolf Poolman, Prof, LUMC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2014

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Faktiske)

31. december 2019

Datoer for studieregistrering

Først indsendt

3. maj 2021

Først indsendt, der opfyldte QC-kriterier

24. oktober 2021

Først opslået (Faktiske)

3. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • W.20.018)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

We will derive data of patients undergoing primary knee arthroplasty from the Dutch Arthroplasty Register, the "Landelijke Registratie Orthopedische Implantaten" (LROI).

We have submitted a research application to use data of the LROI for our study, which was judged by the "Wetenschappelijke Adviesraad" (WAR). After approval af the WAR, further agreements have been made between our research group and the LROI about the way in which the data were securely prepared. The specific dataset for our research question was prepared by the LROI and labeled by a specific research number (LROI2020-057 Poolman - Depressie en pijn bij KA). The LROI does not include names and addresses of patients. The citizen service number is encrypted by the LROI. The researchers will have no access to identifiable patient data.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Slidgigt i knæet

Kliniske forsøg med Knee Arthroplasty, knee revision arthoplasty

3
Abonner