Joint Awareness After Total Knee Replacement

September 17, 2023 updated by: İsmail Demirkale, Saglik Bilimleri Universitesi

Joint Awareness After Cemented or Cementless Total Knee Replacement: Does it Change?

Total knee replacement (TKR) is accepted as treatment of choice for end stage gonarthrosis. It is performed cemented or cementless and although cemented implants were shown to decrease bone density more than cementless fixations there is no evidence-based difference between them in the literature. As far as the investigators are concerned, the effect of cementation on patients' joint perception has never been studied so far.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this longitudinal case-control study, joint awareness in prosthetic reconstruction was evaluated in 150 knees (75 cemented TKR, 75 cementless TKR) of 136 patients. They were operated between 2015 and 2017 in our institution with minimum 5 years of follow up. All the patients in each group were operated by two senior surgeons that were experienced for more than 10 years in arthroplasty. To reduce selection bias, logistic regression was used to develop propensity-matched pairs based on gender, age, body mass index (BMI), preoperative coronal plane deformity, preoperative range of motion (ROM) and appropriateness for TKA indication. Demographic and clinical data including sex, age and time since surgery were collected. The subjects' joint perception and the WOMAC clinical scores were recorded and compared. Joint awareness is assessed with Forgotten Joint Score (FJS) which has 12 questions and with Patient's Joint Perception questionnaire (PJP) which is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worse possible case "a non-functional joint". Other than clinical scores, laboratory parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic loosening, periprosthetic fracture, instability) and revision rates were also compared.

Study Type

Observational

Enrollment (Actual)

150

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with primary end stage varus osteoarthritis of the knee

Description

Inclusion Criteria:

  • primary knee osteoarthritis
  • "appropriate'' TKA indication according to Modified Escobar System

Exclusion Criteria:

  • secondary osteoarthritis
  • previous surgery to the knee
  • valgus knee
  • uncontrolled diabetes

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
Cd-TKR
Bicompartmental cemented cruciate retaining Total knee replacement
Cs-TKR
Bicompartmental cementless cruciate retaining Total knee replacement
Procedure: CEMENTLESS TOTAL KNEE REPLACEMENT
CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forgotten Joint Score-12 (FJS-12)
Time Frame: 1 year after index surgery and at the end of 5th year
a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment and uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3,sometimes; and 4, mostly) with high scores indicate good outcome, which means a high degree of "forgetting" the joint
1 year after index surgery and at the end of 5th year
Patient's Joint Perception questionnaire (PJP)
Time Frame: 1 year after index surgery and at the end of 5th year
The PJP is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worsening gradually as Artificial joint with no restriction, Artificial joint with minimal restriction, Artificial joint with major restriction and "a non-functional joint"
1 year after index surgery and at the end of 5th year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 1 year after index surgery and at the end of 5th year
The WOMAC is a specific, valid, and reliable measure for OA, consisting of 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using a Likert scale as follows: 0=nothing, 1=mild, 2=moderate, 3=severe, 4=very severe. The score for each section is calculated separately, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function.
1 year after index surgery and at the end of 5th year

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

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, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2470

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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