Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158646
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-14
Brief Title:
Mechanically or Kinematically Aligned Total Knee Prosthesis
Sponsor:
Clinique du Sport Bordeaux Mérignac
Organization:
Clinique du Sport Bordeaux Mérignac
Study Overview
Official Title:
Mechanically or Kinematically Aligned Total Knee Prosthesis Prospective and Comparative Study of Clinical Stereoradiographic and Biomechanical Results
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOMAKA
Brief Summary:
The mechanical alignment technique Mechanical Alignment - MA of a total knee prosthesis TKA was developed with the aim of making the installation of a TKA simple and reproducible and that the prosthetic biomechanics are acceptable thus promoting good longevity of implants This is a technique that does not aim to restore the constitutional anatomy of the knee bone cuts are systematically made at fixed angles in the 3 planes of space in relation to the mechanical axes of the long bones femur and tibia This non-personalized implantation technique therefore systematically alters the anatomy laxity and kinematics of the knee causing up to 50 of residual symptoms after prosthetic implantation and 20 of dissatisfied patients
In order to improve the clinical results of TKA a new more personalized and physiological technique was developed in 2007 called Kinematic Alignment KA This technique aims to restore the pre-arthritic anatomy unique to each knee Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA
In order to improve the clinical results of TKA a new more personalized and physiological technique was developed in 2007 called Kinematic Alignment KA This technique aims to restore the pre-arthritic anatomy unique to each knee Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None