Risk of Chronic Post-surgical Pain After TKA

October 6, 2023 updated by: Do-Hyeong Kim, Gangnam Severance Hospital

Risk of Chronic Post-surgical Pain After Simultaneous Versus Staged Bilateral Knee Arthroplasty: A Retrospective Study With Propensity Score Matching

Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

403

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.

Description

Inclusion Criteria:

  • From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.

Exclusion Criteria:

  • Patients whose post-operative pain information cannot be confirmed through outpatient visit records 1 year after surgery
  • Those who have undergone surgery other than knee arthritis surgery within 1 year after surgery

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
Simultaneous BTKA
Procedure: Simultaneous BTKA
Simultaneous BTKA
Staged BTKA
Procedure: Staged BTKA
Staged BTKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic post-surgical pain at one year follow up
Time Frame: at one year follow up after surgery
Numeric rating scale (0: no pain, 10: extreme pain)
at one year follow up after surgery

Collaborators and Investigators

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

Sponsor

Gangnam Severance Hospital

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)

October 12, 2012

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2023-0080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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