NCT03446391

Matched Pair Study - Kinematic Vs Mechanical Alignment

Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.

Detailed description

The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.

Conditions

• Osteoarthritis, Knee
• Joint Disease

Interventions

Type	Name	Description
PROCEDURE	Kinematic alignment	The principle for kinematically aligning the femoral component is to remove the correct amount of bone and cartilage from the distal and posterior femur after accounting for wear and saw blade kerf, so that the total thickness of the missing and removed tissue matches the thickness of the femoral component.
PROCEDURE	Mechanical alignment	Classic mechanical alignment (MA) in total knee arthroplasty (TKA) is meant to co-align the prosthetic components to the mechanical axes of the femur and tibia and restore neutral overall limb alignment
DEVICE	GMK Sphere®	The GMK Sphere® is a total knee prosthesis . The design of the GMK Sphere® is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE polyethylene insert with a concave spherical medial compartment.

Timeline

• Start date: 2018-01-02
• Primary completion: 2019-05-18
• Completion: 2019-05-18
• First posted: 2018-02-26
• Last updated: 2024-12-16

Locations

1 site across 1 country: Germany