Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

Damascus University

Status: Completed

Conditions: Arthritis Knee; Joint Diseases; Arthroplasty Complications

Treatments: Procedure: Total knee arthroplasty with a Fixed Bearing system.; Procedure: Total knee arthroplasty with a Mobile Bearing system.

Study type: Interventional

Funder types: Other

Identifiers

NCT05696418

UDMS-Orthopedics-2-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 76 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Mobile Bearing Design TKA

Experimental group

Description:

Patients who were randomized to receive the PFC Sigma Mobile Bearing TKA system

Treatment:

Procedure: Total knee arthroplasty with a Mobile Bearing system.

Fixed Bearing Design TKA

Experimental group

Description:

Patients who were randomized to receive the PFC Sigma Fixed Bearing TKA system

Treatment:

Procedure: Total knee arthroplasty with a Fixed Bearing system.