Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603103
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Prospective Randomized Study Comparing the SpheriKA MEDACTA and Origin SYMBIOS Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Randomized Study Comparing the SpheriKA MEDACTA and Origin SYMBIOS Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAOR
Brief Summary:
The traditional technique for implanting a total knee prosthesis known as mechanical alignment does not aim to preserve the original anatomy and laxity of the knee Instead the implants are systematically aligned to create a non-naturally straight lower limb Respectively 20 and 50 of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result and complain of residual symptoms A newer more physiological technique for implanting a total knee prosthesis known as kinematic alignment aims to recreate the unique native anatomy and laxity of each patient39s knee The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient39s experience of his or her prosthetic knee As a result of the emergence of the kinematic alignment technique two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique A made-to-measure total knee prosthesis ORIGIN - Symbios Yverdon-les-Bains Switzerland was developed with the aim of reproducing the unique contour of each implanted knee Another manufacturer opted to develop a generic total knee prosthesis implant SPHERIKA - Medacta Castel San Pietro Switzerland but with a design optimized for the kinematic alignment technique These two models of total knee prosthesis each offer advantages and limitations that need to be assessed The main aim of this study is therefore to compare the joint perception of these 2 prostheses It will also look at the clinical and imaging results the biomechanics of the prosthetic knee during gait and the muscular strength of knee extension obtained for these 2 total knee prostheses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None