The personalKNEE Trial
NCT Number: NCT06507046
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: PROCEDURE: Total knee replacement
Sponsor: Helse Møre og Romsdal HF
Collaborators: Oslo University Hospital|National Taiwan Normal University|University of Oslo|Sectra AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2035-05-01
Locations: Kristiansund Hospital, Møre and Romsdal Hospital Trust, Kristiansund, Møre And Romsdal, 6508, Norway

Summary:
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.

Primary Outcome Measures: MTPM, Maximum Total Point Motion measured by CT -based RSA in millimeters., 2 years
Secondary Outcome Measures: XYZ translation, Translation of implant measured by CT -based RSA in millimeters, 2 years|XYZ rotation, Rotation of implant measured by CT -based RSA in degrees, 2 years|Steps per day, ActivePAL accelerator registration of mean steps per day measured 24/7 for a week, 1 year and 2 years|Walking speed, ActivePAL accelerator registration of mean meter per second measured 24/7 for a week, 1 and 2 years|Stair climbing, Standardized climbing and descending of stairs up and down. Time in seconds measured up, down and total., 1 and 2 years|Maximal voluntary contraction flexion, Isometric contraction at 90 degrees knee flexion measured in Newtons with Tindeq force cell, 1 and 2 years|Maximal voluntary contraction extension, Isometric contraction at 90 degrees knee extension measured in Newtons with Tindeq force cell, 1 and 2 years|Maximal voluntary contraction, Isometric contraction at 90 degrees knee flexion measured in Newtons with Tindeq force cell, 1 and 2 years|Sit to stand test, Maximum number of repetitive transitions from sitting on a chair to standing without the use of hands during 30 seconds, 1 and 2 years|KOOS score, Knee Injury and Osteoarthritis of 5 dimensions measuring activity of daily living (ADL), Quality of life, Sport and recreation, pain and symptoms. From 0 (bad) to 100 (excellent), 1 and 2 years|FJS, Forgotten Joint Score is a 12 item scale assessing the ability to forget the operated joint as artificial during activities of daily living. Ranges from 0 (bad) to 100 (excellent), 1 and 2 years|Eq-5D, EuroQol 5 Dimensions is a generic patient reported outcome measure measuring quality of life. The scale ranges from 100 ('the best imaginable health state') to 0 ('the worst imaginable health state' )., 1 and 2 years|VAS, The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'), 1 and 2 years