Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617871
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Single-blinded Clinical Trial Comparing Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Knee replacement surgery can be performed in one of two ways Traditionally the goal was for the new joint to be in a neutral position with respect to the femur thigh bone This is called Mechanical Alignment MA The neutral position is different than the human knees natural position so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee This is called Kinemetic Alignment KA KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case
Some studies have found no difference in outcomes between MA and KA whereas others have found KA to be superior But these were small studies or studies that did not consider patient-rated outcomes
Some studies have found no difference in outcomes between MA and KA whereas others have found KA to be superior But these were small studies or studies that did not consider patient-rated outcomes
Detailed Description:
Up to 20 of patients that report dissatisfaction and chronic pain following Total knee arthroplasty TKA Prior research has identified patient demographic comorbidity and expectations as factors that are associated with dissatisfaction Emerging literature has also suggested that surgical factors including component alignment soft tissue balance and kinematics may play a role in patient satisfaction and that modifications to alignment may result in better function than performing soft tissue releases Personalized alignment strategies have been proposed that aim to more closely recreate native knee morphology and kinematics Kinematic alignment KA describes a technique that aims to restore the pre-arthritic joint surfaces and alignment of the femur and tibia by removing the bone and cartilage thickness that will be replaced by the implant taking into account cartilage wear KA can therefore be conceptualized as a resurfacing procedure wherein native joint surfaces are replaced by prosthetic surfaces but the position and alignment of the joint surfaces are not changed This contrasts with mechanical alignment MA in which implants are positioned perpendicular to the mechanical axes of the femur and tibia in a manner independent of the pre-arthritic joint surfaces and soft tissue releases are performed to bring limb alignment into mechanical neutral
There have been prior randomized trials comparing kinematic and mechanical alignment and these have had mixed results regarding the superiority of one approach over the other The majority of these trials did not use the same operative modality for both groups manual vs computer-assisted techniques or did not include relevant patient reported outcomes PROs There is a need for a prospective randomized trial comparing outcomes following kinematic vs mechanical alignment TKA with the same operative modality used in both groups with inclusion of relevant PROs
There have been prior randomized trials comparing kinematic and mechanical alignment and these have had mixed results regarding the superiority of one approach over the other The majority of these trials did not use the same operative modality for both groups manual vs computer-assisted techniques or did not include relevant patient reported outcomes PROs There is a need for a prospective randomized trial comparing outcomes following kinematic vs mechanical alignment TKA with the same operative modality used in both groups with inclusion of relevant PROs
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