Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS (Persona TKA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Knee Arthritis; Joint; Arthrosis, Primary
• Intervention / Treatment: Diagnostic test: Biomechanics; Procedure: Total knee replacement; Diagnostic test: CT scan; Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bartosz Maciąg, MD; Phone Number: 0048 881568144; Email: bartosz.maciag94@gmail.com

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Department of Othopedics and Rehabilitation, Medical University of Warsaw
    • Contact: Bartosz M. Maciąg, MD; Phone Number: +48 881 568 144; Email: bmaciag@wum.edu.pl
    • Principal Investigator: Artur Stolarczyk, MD, PhD
    • Principal Investigator: Bartosz M. Maciąg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
2. Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
3. Aged 18 or over
4. Patient willing to provide full informed consent to the trial

Exclusion Criteria:

1. Listed for a single-stage bilateral TKR procedure
2. Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
3. Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
4. Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
5. Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
6. Inflammatory arthritis
7. Previous septic arthritis in the affected knee joint
8. Previous surgery to the collateral ligaments of the affected knee
9. A contralateral total knee replacement that has been implanted less than one year from the date of consultation
10. A contralateral total knee replacement that is severely painful
11. Patients on warfarin or novel oral anticoagulants (NOACs)
12. Will not be resident in the catchment area for at least 6 months post-surgery
13. Undertaking the surgery as a private patient
14. Patients who, in the opinion of the clinical staff, do not have capacity to consent
15. Patients who are pregnant
16. Unable to understand written and spoken Polish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NexGen; Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis	Diagnostic test: Biomechanics; Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively; 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; 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.
ACTIVE_COMPARATOR: Persona MC Retained PCL; Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis	Diagnostic test: Biomechanics; Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively; 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; 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.
ACTIVE_COMPARATOR: Persona MC Sacrificed PCL; Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis	Diagnostic test: Biomechanics; Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patients reported outcome measures - Oxford Knee Score (OKS)	To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes.	baseline (preoperatively) and 6-months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patients reported outcome measures - Oxford Knee Score (OKS)	To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes.	1 week and 6-8 weeks post-operatively
Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)	To explore differences in higher levels of activity and social participation	1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - EuroQol (EQ- 5D-5L)	To explore differences in quality of life	1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - Forgotten Joint Score (FJS)	To explore differences in patient's ability to forget about a joint as a result of successful treatment. Results range from 0 to 100, with higher scores corresponding to better outcomes.	6-8 weeks and 6 months post-operatively
Changes in patients reported outcomes - UCLA (University of California) score	To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes.	6-8 weeks and 6 months post-operatively
Changes in knee range of motion	To explore differences in range of motion (flexion and extension)	preoperatively, 6-8 weeks and 6 months post-operatively
Changes in pain medication	To asses evolution of post-operative knee pain	1 week, 6-8 weeks and 6 months post-operatively
arthroplasty related complications	To count and asses all complications that may occur during surgery and in postoperative period	1 week, 6-8 weeks and 6 months post-operatively
arthroplasty revision surgeries	To count and asses the reason of all revision surgeries that may occur during postoperative period	1 week, 6-8 weeks and 6 months post-operatively
walking abilities	To asses "up and go" time	6-8 weeks and 6 months post-operatively
Length of hospital stay	To measure number of days counting from surgery to the discharge	from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
Biomechanical 3D miotion and emg walking outcomes	Overground walking is measured using 3D Motion analysis and electromyography (EMG)	at baseline, 6-8 weeks and 6 months post-operatively
Radiological outcome on CT scans	Rotational alignment of the total knee component is assessed by measuring the femoral antetorsion, Alignment of the total knee component is assessed by measuring the tibial tubercle-trochlear groove distance (TT-TG)	at baseline preoperatively and 6-months postoperatively
6- minute walking abilities	to asses pace and model of 6-minute walk	6-8 weeks and 6 months post-operatively
Biomechanical stair climbing outcomes	Stair climbing and descending is measured using 3D Motion analysis and EMG	at baseline, 6-8 weeks and 6 months post-operatively
Biomechanical static balance outcomes	Static balance is measured using a force plate	at baseline, 6-8 weeks and 6 months post-operatively
Biomechanical dynamic balance outcomes	Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT)	at baseline, 6-8 weeks and 6 months post-operatively
Leg muscle strength outcomes	Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.	at baseline, 6-8 weeks and 6 months post-operatively

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Director: Artur Stolarczyk, PhD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 25, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; Total Knee Arthroplasty; Nexgen; Persona
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: WarszawMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No