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

July 25, 2021 updated by: Artur Stolarczyk, Medical University of Warsaw

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Othopedics and Rehabilitation, Medical University of Warsaw
        • Contact:
        • Principal Investigator:
          • Artur Stolarczyk, MD, PhD
        • Principal Investigator:
          • Bartosz M. Maciąg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time Frame: baseline (preoperatively) and 6-months postoperatively
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time Frame: 1 week and 6-8 weeks post-operatively
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)
Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
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)
Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
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)
Time Frame: 6-8 weeks and 6 months post-operatively
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
Time Frame: 6-8 weeks and 6 months post-operatively
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
Time Frame: preoperatively, 6-8 weeks and 6 months post-operatively
To explore differences in range of motion (flexion and extension)
preoperatively, 6-8 weeks and 6 months post-operatively
Changes in pain medication
Time Frame: 1 week, 6-8 weeks and 6 months post-operatively
To asses evolution of post-operative knee pain
1 week, 6-8 weeks and 6 months post-operatively
arthroplasty related complications
Time Frame: 1 week, 6-8 weeks and 6 months post-operatively
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
Time Frame: 1 week, 6-8 weeks and 6 months post-operatively
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
Time Frame: 6-8 weeks and 6 months post-operatively
To asses "up and go" time
6-8 weeks and 6 months post-operatively
Length of hospital stay
Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
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
Time Frame: at baseline, 6-8 weeks and 6 months post-operatively
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
Time Frame: at baseline preoperatively and 6-months postoperatively
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
Time Frame: 6-8 weeks and 6 months post-operatively
to asses pace and model of 6-minute walk
6-8 weeks and 6 months post-operatively
Biomechanical stair climbing outcomes
Time Frame: at baseline, 6-8 weeks and 6 months post-operatively
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
Time Frame: at baseline, 6-8 weeks and 6 months post-operatively
Static balance is measured using a force plate
at baseline, 6-8 weeks and 6 months post-operatively
Biomechanical dynamic balance outcomes
Time Frame: at baseline, 6-8 weeks and 6 months post-operatively
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
Time Frame: at baseline, 6-8 weeks and 6 months post-operatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Artur Stolarczyk, PhD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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