Status:
RECRUITING
The personalKNEE Trial
Lead Sponsor:
Helse Møre og Romsdal HF
Collaborating Sponsors:
Oslo University Hospital
National Taiwan Normal University
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 mechani...
Detailed Description
Mechanical alignment (MA) has for many years been the most used surgical alignment technique in total knee arthroplasty (TKA). This means that regardless of constitutional native anatomy (i.e. valgus ...
Eligibility Criteria
Inclusion
- • femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA
Exclusion
- 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
- Patients with ongoing cancer therapy
- Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification \>3
- Patients in the need of walking aid devices
- Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.
Key Trial Info
Start Date :
August 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2035
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06507046
Start Date
August 25 2024
End Date
May 1 2035
Last Update
June 11 2025
Active Locations (1)
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1
Kristiansund Hospital, Møre and Romsdal Hospital Trust
Kristiansund, Møre and Romsdal, Norway, 6508