Journey II vs Persona Knee Systems - RCT

NCT05038670 | Completed

• 1 other identifier: WarsawMU/persona
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

PERSONA

ACTIVE COMPARATOR

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system

Device: Total Knee Replacement

Journey II

ACTIVE COMPARATOR

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith\&Nephew Journey II system

Device: Total Knee Replacement

Interventions

Total Knee Replacement DEVICE

Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS

Journey II; PERSONA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 04-749, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Artur Stolaerczyk, MD, PhD

  Department of Orthopedics and Rehabilitation, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will not be informed which type of prosthesis was used in their particular case. Outcomes Assessor, who will be not present during surgery, will not be informed which type of prosthesis was used in particular patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Orthopedics and Rehabilitation

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: November 24, 2020
• Last Updated: September 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)