Knee OsteoarthritisPersona TKANCT04164147
Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS
A study testing Total knee replacement, CT scan and Biomechanics in people with Knee Osteoarthritis and Knee Arthritis, run by Medical University of Warsaw at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis, Joint; Arthrosis, Primary
- What is being tested?
- Total knee replacement, CT scan and Biomechanics
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- A contralateral total knee replacement that has been implanted less than one year from the date of consultation
- A contralateral total knee replacement that is severely painful
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw
Bartosz M. Maciąg, MD, 881 568 144 ext. +48, bmaciag@wum.edu.pl
Artur Stolarczyk, MD, PhD
About this study
Official title: 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
Read the 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.
- Being tested
- Total knee replacement, CT scan, Biomechanics, one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant
- Keywords
- Total Knee Arthroplasty, Nexgen, Persona, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacementProcedure or surgery
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
CT scanDiagnostic test
CT scans of the affected knee joint before and after the surgical procedure
BiomechanicsDiagnostic test
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NexGen | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis Receives: Procedure: Total knee replacement; Diagnostic Test: CT scan; Diagnostic Test: Biomechanics; Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant |
| Persona MC Retained PCL | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis Receives: Procedure: Total knee replacement; Diagnostic Test: CT scan; Diagnostic Test: Biomechanics; Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant |
| Persona MC Sacrificed PCL | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis Receives: Procedure: Total knee replacement; Diagnostic Test: CT scan; Diagnostic Test: Biomechanics; Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (preoperatively) and 6-months postoperatively
Secondary outcomes (18)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6-8 weeks and 6 months post-operatively
Changes in knee range of motion
To explore differences in range of motion (flexion and extension)
Measured: preoperatively, 6-8 weeks and 6 months post-operatively
Changes in pain medication
To asses evolution of post-operative knee pain
Measured: 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
Measured: 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
Measured: 1 week, 6-8 weeks and 6 months post-operatively
walking abilities
To asses "up and go" time
Measured: 6-8 weeks and 6 months post-operatively
Length of hospital stay
To measure number of days counting from surgery to the discharge
Measured: 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)
Measured: 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)
Measured: at baseline preoperatively and 6-months postoperatively
6- minute walking abilities
to asses pace and model of 6-minute walk
Measured: 6-8 weeks and 6 months post-operatively
Biomechanical stair climbing outcomes
Stair climbing and descending is measured using 3D Motion analysis and EMG
Measured: at baseline, 6-8 weeks and 6 months post-operatively
Biomechanical static balance outcomes
Static balance is measured using a force plate
Measured: 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)
Measured: 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.
Measured: at baseline, 6-8 weeks and 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Artur Stolarczyk, PhD, Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164147
- Sponsor's protocol ID
- WarszawMU
- Acronym
- Persona TKA
- Status last verified
- Jul 2021
- First submitted
- 31 Oct 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maciag BM, Kordyaczny T, Jegierski D, Lapinski M, Dorocinska M, Zarnovsky K, Maciag GJ, Adamska O, Stolarczyk A. Differences in joint line level and posterior condylar offset during total knee replacement with use of gap-balancing and measured resection techniques-matched cohort study. BMC Musculoskelet Disord. 2023 Jul 25;24(1):610. doi: 10.1186/s12891-023-06722-1.
PubMed 37491199
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04164147
- Acronym / sponsor ID
- Persona TKA / WarszawMU
- Keywords
- Total Knee Arthroplasty, Nexgen, Persona, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NexGen | Active comparator | Procedure: Total knee replacement, Diagnostic Test: CT scan, Diagnostic Test: Biomechanics, Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implantPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis |
| Persona MC Retained PCL | Active comparator | Procedure: Total knee replacement, Diagnostic Test: CT scan, Diagnostic Test: Biomechanics, Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implantPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis |
| Persona MC Sacrificed PCL | Active comparator | Procedure: Total knee replacement, Diagnostic Test: CT scan, Diagnostic Test: Biomechanics, Device: one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implantPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee replacementParticipant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant | Procedure or surgery | NexGen, Persona MC Retained PCL, Persona MC Sacrificed PCL |
| CT scanCT scans of the affected knee joint before and after the surgical procedure | Diagnostic test | NexGen, Persona MC Retained PCL, Persona MC Sacrificed PCL |
| BiomechanicsParticipants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively | Diagnostic test | NexGen, Persona MC Retained PCL, Persona MC Sacrificed PCL |
| one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implantParticipant 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. | Device | NexGen, Persona MC Retained PCL, Persona MC Sacrificed PCL |
Primary outcome
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.
18 secondary outcomes
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
Time frame: 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
Changes in patients reported outcomes - EuroQol (EQ- 5D-5L)
Time frame: 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
Changes in patients reported outcomes - UCLA (University of California) score
Time frame: 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
Changes in pain medication
Time frame: 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
arthroplasty revision surgeries
Time frame: 1 week, 6-8 weeks and 6 months post-operatively
walking abilities
Time frame: 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
Biomechanical 3D miotion and emg walking outcomes
Time frame: at baseline, 6-8 weeks and 6 months post-operatively
Radiological outcome on CT scans
Time frame: at baseline preoperatively and 6-months postoperatively
6- minute walking abilities
Time frame: 6-8 weeks and 6 months post-operatively
Biomechanical stair climbing outcomes
Time frame: 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
Biomechanical dynamic balance outcomes
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 37491199Maciag BM, Kordyaczny T, Jegierski D, Lapinski M, Dorocinska M, Zarnovsky K, Maciag GJ, Adamska O, Stolarczyk A. Differences in joint line level and posterior condylar offset during total knee replacement with use of gap-balancing and measured resection techniques-matched cohort study. BMC Musculoskelet Disord. 2023 Jul 25;24(1):610. doi: 10.1186/s12891-023-06722-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artur Stolarczyk, PhD study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement, CT scan and Biomechanics in people with Knee Osteoarthritis and Knee Arthritis, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Maciąg, MD (881568144 ext. 0048, bartosz.maciag94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patients reported outcome measures - Oxford Knee Score (OKS) (time frame: baseline (preoperatively) and 6-months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.