MedTrace Logo

Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

NCT04436211 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-06-17

No results posted yet for this study

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.

Conditions

  • Osteo Arthritis Knee

Interventions

PROCEDURE

Total Knee Arthroplasty

The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2021-02-15
Completion
2022-03-30

Countries

  • Austria

Study Locations

More Related Trials

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 NCT04436211 on ClinicalTrials.gov