JOINT AWARENESS AFTER TOTAL KNEE REPLACEMENT

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Completed

CT.gov ID

NCT06033625

Collaborator

(none)

150

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Arthroplasty Complications	Procedure: CEMENTLESS TOTAL KNEE REPLACEMENT

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

JOINT AWARENESS AFTER CEMENTED OR CEMENTLESS TOTAL KNEE REPLACEMENT: DOES IT CHANGE?

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Forgotten Joint Score-12 (FJS-12) [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
Patient's Joint Perception questionnaire (PJP) [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"

Secondary Outcome Measures

Western Ontario and McMaster Universities Arthritis Index (WOMAC) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saglik Bilimleri Universitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

İsmail Demirkale, Clinical professor, Saglik Bilimleri Universitesi

ClinicalTrials.gov Identifier:

NCT06033625

Other Study ID Numbers:

2470

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by İsmail Demirkale, Clinical professor, Saglik Bilimleri Universitesi

Joint Awareness

Total Knee Replacement

Cementless

Forgotten Joint Score

Patient's Joint Perception

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 13, 2023