NCT04164147

Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS

Comparison of the Persona Medial Congruent Retained Posterior-Cruciate Ligament vs. Persona Posterior-stabilized vs. NexGen Posterior-Stabilized Total Knee Arthroplasty a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen and Zimmer Biomet PERSONA

Detailed description

Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. To date, no studies have investigated the kinematic outcomes of different total knee replacement prosthesis designs through a range of typical activities of everyday mobility (functional outcomes). Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and CT measurement, both pre- and post-operatively, between two knee prosthesis including one that has been designed to improve functional outcomes.

Conditions

• Knee Osteoarthritis
• Knee Arthritis
• Joint; Arthrosis, Primary

Interventions

Type	Name	Description
PROCEDURE	Total knee replacement	Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
DIAGNOSTIC_TEST	CT scan	CT scans of the affected knee joint before and after the surgical procedure
DIAGNOSTIC_TEST	Biomechanics	Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
DEVICE	one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant	Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-12-01
• Completion: 2022-12-31
• First posted: 2019-11-15
• Last updated: 2021-08-02

Locations

1 site across 1 country: Poland