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Matched Pair Study - Kinematic Vs Mechanical Alignment

NCT03446391 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Joint Disease

Interventions

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.

Sponsors & Collaborators

  • Medacta International SA

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2019-05-18
Completion
2019-05-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446391 on ClinicalTrials.gov