Clinical Trials Directory

Trials / Completed

CompletedNCT05696418

Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

Effect of Using Mobile Bearing on the Incidence Rate of Anterior Knee Pain in Primary Total Knee Arthroplasty Without Patellar Resurfacing (A Randomized Controlled Clinical Trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDURETotal knee arthroplasty with a Mobile Bearing system.The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Mobile Bearing system without resurfacing the patella.
PROCEDURETotal knee arthroplasty with a Fixed Bearing system.The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Fixed Bearing system without resurfacing the patella.

Timeline

Start date
2021-01-15
Primary completion
2024-03-15
Completion
2024-03-25
First posted
2023-01-25
Last updated
2024-07-16

Locations

1 site across 1 country: Syria

Source: ClinicalTrials.gov record NCT05696418. Inclusion in this directory is not an endorsement.