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

October 24, 2021 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

70754

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Knee Arthroplasty, knee revision arthoplasty
Primary knee arthroplasty (e.g., total, unicondylar and patellofemoral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision surgery after knee arthroplasty
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Rudolf Poolman, Prof, LUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W.20.018)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on Knee Arthroplasty, knee revision arthoplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe