Journey II vs Persona Knee Systems - RCT

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038670
• Other study ID #: WarsawMU/persona
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 24, 2020

Study information

• Verified date: August 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 24, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw

• Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments

• Aged 18 or over

• Patient willing to provide full informed consent to the trial

Exclusion Criteria:

• Listed for a single-stage bilateral TKR procedure

• Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure

• Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur

• Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater

• Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety

• Inflammatory arthritis

• Previous septic arthritis in the affected knee joint

• Previous surgery to the collateral ligaments of the affected knee

• Patients on warfarin or novel oral anticoagulants (NOACs)

• Will not be resident in the catchment area for at least 6 months post-surgery

• Undertaking the surgery as a private patient

• Patients who, in the opinion of the clinical staff, do not have capacity to consent

• Patients who are pregnant

• Unable to understand written and spoken Polish

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total Knee Replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS

Locations

Country	Name	City	State
Poland	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw	Mazovia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)	To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 100, with higher scores corresponding to better outcomes.	baseline (preoperatively) and 1 year postoperatively
Primary	Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)	To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis. Results range from 0 to 96, with higher scores corresponding to worse outcomes.	baseline (preoperatively) and 1 year postoperatively
Primary	Values of components rotation	Values of external or internal rotation of components measured in computed tomography postoperatively. Values in degrees in regards to anatomic bone landmarks	1-day postoperatively