Joint Awareness After Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06033625
• Other study ID #: 2470
• Status: Completed
• Start date: January 2015
• Est. completion date: January 2019

Study information

• Verified date: September 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2019
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• CEMENTLESS TOTAL KNEE REPLACEMENT
CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forgotten Joint Score-12 (FJS-12)	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
Primary	Patient's Joint Perception questionnaire (PJP)	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	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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