Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic. In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism. In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments. Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival. The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: f
View:

• Primary osteoarthritis of the knee

• 50 years and older

• Participants must be able to give informed consent

Locations
Other Locations
Spain
Elda University Hospital
RECRUITING
Elda
Contact Information
Primary
Alejandro Lizaur-Utrilla, MD, PhD
lizaur1@telefonica.net
+34 966989019
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Medial pivot group
Device used: medial pivot total knee arthroplasty design
Active_comparator: Conventional group
Device used: conventional total knee arthroplasty design
Sponsors
Leads: Elda University Hospital
Collaborators: Universidad Miguel Hernandez de Elche

This content was sourced from clinicaltrials.gov