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

Completed

• Conditions: Psychological Distress; Osteo Arthritis Knee
• Interventions: Procedure: Knee Arthroplasty, knee revision arthoplasty

• Registration Number: NCT05105646
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2021-05-03
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70754

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Knee Arthroplasty, knee revision arthoplasty	• 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 Outcome Measures

Name	Time	Method
Revision surgery after knee arthroplasty	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)).

Trial Locations

Locations (1)

LUMC; 🇳🇱 Leiden, Netherlands