The personalKNEE Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHelse Møre og Romsdal HF

About this trial

Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

serious psychiatric disorders

dementia

drug abuse

patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total knee replacement

    Procedure/Surgery

    Mechanical or Personalized alignment

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Mechanical alignmentActive comparator 1 intervention
Group B: Personalized alignmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTPM

Maximum Total Point Motion measured by CT -based RSA in millimeters.

Time frame
2 years

Secondary outcomes

1

XYZ translation

Translation of implant measured by CT -based RSA in millimeters

Time frame
2 years
2

XYZ rotation

Rotation of implant measured by CT -based RSA in degrees

Time frame
2 years
3

Steps per day

ActivePAL accelerator registration of mean steps per day measured 24/7 for a week

Time frame
1 year and 2 years
4

Walking speed

ActivePAL accelerator registration of mean meter per second measured 24/7 for a week

Time frame
1 and 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helse Møre og Romsdal HF

Lead sponsor

Oslo University Hospital

Collaborator

National Taiwan Normal University

Collaborator

University of Oslo

Collaborator

Sectra AB

Collaborator