Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

Not Applicable

Completed

• Conditions: Arthritis Knee; Joint Diseases; Arthroplasty Complications
• Interventions: Procedure: Total knee arthroplasty with a Mobile Bearing system.; Procedure: Total knee arthroplasty with a Fixed Bearing system.

• Registration Number: NCT05696418
• Lead Sponsor: Damascus University

Brief Summary

Osteoarthritis is the most common cause of chronic joint disease, and its incidence has increased due to the high average life expectancy, in addition to the high incidence of obesity. Total knee arthroplasty is currently an accepted treatment for severe degenerative conditions and there are various implant systems with special features depending on component geometry, degree of fit of the articular surfaces, and fixation techniques. A tibial component with mobile polyethylene has been developed as an alternative to fixed polyethylene because it has theoretical advantages in terms of increasing the range of motion, reducing wear conditions, and reducing the incidence of anterior knee pain when the articular surface of the patella is not resurfaced.

Detailed Description

The study is a randomized controlled clinical trial where the sample will be collected within one year from the date of approval of the Scientific Research Council at Damascus University. The sample consists of patients undergoing a total primary knee arthroplasty without patellar resurfacing following primary arthritis knee. The patients will be randomly divided into two groups. The first will be a primary total knee arthroplasty with a mobile bearing, and the second group with a fixed bearing. Then the patients will be followed for at least one year.

The data of the patients included in the study will be collected before the surgical operation, then the surgery; followed up for at least one year after it, and then compared between the two groups in terms of a range of motion and functional and clinical results according to the Knee Society Score (KSS) and the anterior knee pain scale, and patient satisfaction assessment according to the Forgotten Joint Scale (FJS).

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-25
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Patients with expected primary total knee arthroplasty

Exclusion Criteria

• Mediolateral instability
• Infective arthritis
• Severe deformity
• Revision
• Patients with severe obesity according to the Body Mass Index (BMI < 35).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Bearing Design TKA	Total knee arthroplasty with a Mobile Bearing system.	Patients who were randomized to receive the PFC Sigma Mobile Bearing TKA system
Fixed Bearing Design TKA	Total knee arthroplasty with a Fixed Bearing system.	Patients who were randomized to receive the PFC Sigma Fixed Bearing TKA system

Primary Outcome Measures

Name	Time	Method
Anterior knee pain	1-2 years after surgery	Anterior knee pain will be assessed by questionnaire.

Secondary Outcome Measures

Name	Time	Method
Forgotten Joint Scale (FJS)	1-2 years after surgery	Patient satisfaction will be assessed by Forgotten Joint Scale (FJS). The FJS-12 consists of twelve equally-weighted questions that are each answered on a five-level Likert scale aimed to measure patient satisfaction. The questionnaire was developed with the consideration that joint awareness is a very important and highly discriminative outcome parameter, especially in patients with good-to-excellent joint function. Answers to each question are individually scored and summed to create a raw composite score that is normalized to range from 0 (worst condition) to 100 points (best condition)
Knee Society Score (KSS)	1-2 years after surgery	Clinical and functional outcomes will be assessed by Knee Society Score (KSS). The knee society score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The Knee Society Score is divided into three sessions: it consists of the Knee Score (100 points), the Knee Function (100 points), and the patient classification system. The classification system separates the patients into three categories depending on their medical conditions - A: unilateral or bilateral (contralateral knee operated successfully); B: unilateral -contralateral knee symptomatic; C: multiple arthritis. The two scores are initially marked at zero and points are assigned or deducted according to specific criteria.
perioperative complications	assessed within two weeks intervals until 6 months after surgery	such as infection, VET, etc

Trial Locations

Locations (1)

Damascus university; 🇸🇾 Damascus, Syrian Arab Republic