Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

Status Recruiting

Clinical Trial Summary

A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement.

Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.

Thus, the kinematic alignment represents one of the few new developments in TKA.

Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.

The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.

In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.

Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.

This study is a monocentric, prospective, randomized and controlled open study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04436211
Study type	Observational [Patient Registry]
Source	Medical University of Graz
Contact	Patrick Sadoghi
Phone	004331638580971
Email	patrick.sadoghi@medunigraz.at
Status	Recruiting
Phase
Start date	February 15, 2020
Completion date	March 30, 2022

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