Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of an Old Versus a New Total Knee Replacement
Sponsor: Helse-Bergen HF
Summary
A randomized controlled clinical and RSA study, comparing 2 knee implants: 1. NexGen CR cemented total knee arthroplasty 2. Persona CR cemented total knee arthroplasty 3 hospitals will participate in the study: * Helse Bergen HF, Kysthospitalet i Hagavik (KIH) * Helse Førde HF, Lærdal sykehus * Helse Bergen HF, Haukeland universitetssykehus (HUS) 1-3 surgeons in each hospital will perform the operations. There will be 80 patients in the 2 groups; a total of 160 study patients will be included. 30 in each group will be included for RSA. Radiostereometric analysis (RSA) will be used to measure migration and subsidence of components in addition to regular radiographs. 3 different knee scoring systems will be used to evaluate satisfaction and function. An activity monitor will be used to assess real-life physical behavior and walking speed to assess objectively measured mobility. Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.
Official title: A Randomized Controlled Clinical and RSA Study of 2 Total Knee Replacement Designs: A Comparison of Nexgen CR and Persona CR
Key Details
Gender
All
Age Range
Any - 80 Years
Study Type
INTERVENTIONAL
Enrollment
185
Start Date
2017-05-18
Completion Date
2029-07-05
Last Updated
2025-09-18
Healthy Volunteers
Yes
Conditions
Interventions
RSA radiostereometric analysis
Tantalum beads will be inserted in polyethylene Component and in bone to assess micromotion of Components in radiographs
Clinical comparison
ActivePAL, walking speed
Locations (1)
Helse Bergen, Kysthospitalet i Hagavik
Hagavik, Norway