NCT05038670

Journey II vs Persona Knee Systems - RCT

Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system

Detailed description

The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system. To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \[1:1\]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career. Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales. 1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Total Knee Replacement	Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-05-01
• Completion: 2020-11-24
• First posted: 2021-09-09
• Last updated: 2021-09-09

Locations

1 site across 1 country: Poland