Osteoarthritis, KneeMP-PersonaNCT03681977
Clinical Outcomes of MP Persona vs. Persona Knee-PS
A study testing Zimmer MP Persona and Zimmer Persona Knee-PS in people with Osteoarthritis, Knee, run by Lady Davis Institute at 3 sites in Canada.
Trial summary
Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Zimmer MP Persona and Zimmer Persona Knee-PS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Sep 2019to 30 Jun 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with osteoarthritis, who in the opinion of the investigator, are suitable candidates for primary total knee replacement using the devices specified in the protocol;
- Males and females between 18 - 80 years at the time of surgery;
- Individuals who understand the conditions of the study and are willing and able to provide informed consent for participation in the study;
- Individuals who are willing and able to participate for the length of the prescribed term of follow-up;
- Individuals who are willing and able to complete all the assessments specified by the study protocol.
Who cannot join
- The presence of previous failed lower extremity arthroplasty or metalwork in situ;
- Patients with severe hip osteoarthritis;
- Patients with lower extremity trauma requiring surgery within 1 year;
- Patients with inflammatory arthritis, severe neurological conditions, or severe cardiovascular conditions.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Montreal General Hospital
Montreal, PQ, H3G 1A4
Lethbridge-Layton-MacKay Rehabilitation Centre
Montreal, PQ, H4B 1T3
Jewish General Hospital
Montreal, PQ
About this study
Official title: The Influence of Medial Pivot Knee Arthroplasty Implant Design on Joint Mechanics, Muscle Activation and Clinical Outcomes
Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.
Read the detailed description
This is a prospective, double-blinded, randomized control study comparing the TKA Zimmer Medial Pivot Persona design to the traditional Zimmer Persona Knee-PS. Eighty patients requiring a TKA will be recruited and randomized to one of the two treatment arms following confirmation of eligibility criteria. Forty age and sex matched healthy participants with no knee OA will also be recruited to provide a comparator measure of "normal" joint motion.
Clinical follow-up visits and radiographic assessments will be performed pre- and post-operative at 6-weeks, 1-year, 2-years. Knee kinematics and self-assessment will be completed at the following intervals: pre-operative as baseline assessments for knee motion, 1-year, 2-years. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity. Any other adverse events and complications (i.e, implant failure, re-operation, infection) will be record throughout the study.
Healthy participants will only be assessed once to provide normative data.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Zimmer MP Persona, Zimmer Persona Knee-PS
- Keywords
- Total Knee Arthroplasty, Medial Pivot Knee Implant Design, Knee Joint Mechanics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer MP PersonaDevice
Also called Medial Pivot Persona, Persona knee implant with a Medial Congruent Bearing
The medial pivot Persona® knee implant with a Medial Congruent™ Bearing
Zimmer Persona Knee-PSDevice
Persona the personalized knee system
| Study group | Role | What they receive |
|---|---|---|
| Zimmer MP Persona | Experimental | Zimmer MP Persona is total knee prosthesis intended to resurface the articulating surface of the femoral, tibial and patellar bones. It employs modular components between the tibial plates and articular surfaces and a medial congruent bearing manufactured from Vivacit-E Highly Crosslinked Polyethylene (HXPE). Persona® Medial Congruent Bearing is available in several sizes and offers up to a 13mm anterior lip height to provide greater anterior constraint and subluxation resistance. Can be used with a with both cruciate retaining and posterior stabilized femoral provisionals Receives: Device: Zimmer MP Persona |
| Zimmer Persona Knee-PS | Active comparator | Zimmer Biomet Persona® Knee-PS is a semiconstrained knee prosthesis that employs modular components between the tibial plates and articular surfaces. The device is intended to resurface the articulating surface of the femoral, tibial and patellar bones. The posterior stabilized (PS) femoral provisionals and components can be used with the PS or constrained posterior stabilized (CPS) bearings provisionals and components when the PCL is deficient and removed.The Persona Femur offers 21 distinct profiles, in 2 mm increments. Receives: Device: Zimmer Persona Knee-PS |
| Healthy Participants | No intervention | The control group for the kinematic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee mechanics
nee motion will be assessed using 3-dimensional optical motion capture sampled at 100 Hz, floor and step mounted force plates sampled at 2000 Hz, and wireless 16-channel electromyography (EMG) system sampled at 2000 Hz.
Knee motion trials will require participants to ambulate at self-selected speeds over 8 meters followed by complete step up/down trials on a 20 cm step. For step up, the surgical limb will be placed on the step to start while for step down, both limbs will start on the step. The order of step up and down trials will be randomized. Participants will perform 2 practice trials followed by testing. Testing will proceed until 5 successful trials of each activity are collected. They will be allowed 30 seconds of rest between trials.
The primary motion capture variables will include principal component scores that capture changes in range of motion for knee rotation and flexion angles for each activity.
Measured: pre-operative (as baseline) and at 1 and 2 years following TKA
Secondary outcomes (10)
Muscle activation
Muscle activation will be measured by surface electrodes placed bilaterally over the following muscles: vastus lateralis and medialis, rectus femoris, lateral (biceps femoris) and medial (semitendinosus) hamstrings, and lateral and medial gastrocnemius. The isometric exercises will include: 1) knee extension in sitting with the knee in 45 degrees of flexion; 2) knee flexion in sitting with the knee at 55 degrees of flexion; 3) ankle plantarflexion in long sitting with the ankle in neutral; and 4) standing unilateral heel rise. Participants will perform 1 practice and 2 collection trials for each exercise. They will be allowed 30 seconds of rest between trials.
Measured: pre-operative (as baseline) and at 1 and 2 years following TKA
The 30 seconds Chair Test - Physical Function Performance Test
Participants will be asked to complete "the 30 seconds Chair Test", a physical function performance test measuring the maximum number of sit-to-stand repetitions on a standard chair with a seat height = 46 cm.
Measured: at 1 and 2 years following TKA
The Stair Climb Test - Physical Function Performance Test
After resting for 5 minutes, the participants will be asked to complete "the Stair Climb Test", a physical function performance test assessing the time [seconds] to ascend and descend a 11-step stair, each step 16 cm high.
Measured: at 1 and 2 years following TKA
The 6 Minutes Walk Test - Physical Function Performance Test
After resting for 5 minutes, the participants will be asked to complete "the 6 Minutes Walk Test", a physical function performance test measuring the distance [meters] ambulate in 6 minutes. The participants will be allowed to rest during the test but the timer will not be stopped.
Measured: at 1 and 2 years following TKA
Knee Osteoarthritis and Outcome Score (KOOS) Self-Evaluation Questionnaire for Implant Performance
Participants will be asked to complete the "Knee Osteoarthritis and Outcome Score (KOOS)" questionnaire. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: pre-operative (as baseline) and at 1 and 2 years following TKA
EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance
Participants will be asked to complete the "EQ-5D-5L" questionnaire, a measure of health-related quality of life that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: pre-operative (as baseline) and at 1 and 2 years following TKA
Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance
Participants will be asked to complete the GRC questionnaire to rate the improvement or deterioration over time compared to the pre-operative visit. The GRC is a 15-point scale (-7=Worse, +7=Better) to assess the participant current health status, recall that status at a previous time-point, and then calculate the difference between the two. The magnitude of this difference will be scored on a numerical or visual analogue scale.
Measured: pre-operative (as baseline) and at 1 and 2 years following TKA
Sensitivity to Physical Activity
Sensitivity to Physical Activity will quantify the pain response to standardized physical activity. Participants will be required to rate their pain before and after each Physical Function Performance Tests using a 0 (no pain) to 100 (most pain imaginable) numeric rating scale. To determine the SPA for each test, the pain before the test will be subtracted from the pain after the test.
Measured: at 1 and 2 years following TKA
Radiographs
Radiographs (anteroposterior hip to ankle, standing anteroposterior; standing lateral and patellar axial views) will be taken pre-operatively, intra operatively and at 6 weeks, 1 year and 2 years post-operatively as part of standard care. Radiographic evaluation will consist of the assessment of limb alignment, component position, and presence of radiolucencies or osteolysis. Longitudinal changes of posterior femoral condylar offset and the degree of posterior tibial slope after the surgery will be also determined.
Measured: pre-operatively, intra operatively and at 6 weeks, 1 year and 2 years post-operatively
Adverse Events
Adverse events and unplanned hospital visits will be tracked and documented. This includes wound related problems (infections), deep vein thrombosis, pulmonary embolism, stiffness, implant loosening, implant instability, re-operation or removal of any components for any reason.
Measured: intra operatively and at 6 weeks, 1 year and 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Model description
- A prospective, double-blinded, randomized control study consisting of a clinical follow-up followed by a knee kinematics assessment. Patients outcomes will be measured pre-operatively, and at 1 and 2 years post-surgery. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital, McGill University, Zimmer Biomet, Montreal General Hospital
- Responsible party
- Principal investigator, John Antoniou, MD PhD, Lady Davis Institute
- Investigators
- John Antoniou, MD, PhD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681977
- Sponsor's protocol ID
- CODIM-MBM-17-162
- Acronym
- MP-Persona
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2018
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Medial Pivot Knee Arthroplasty Implant Design on Joint Mechanics, Muscle Activation and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03681977
- Acronym / sponsor ID
- MP-Persona / CODIM-MBM-17-162
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total Knee Arthroplasty, Medial Pivot Knee Implant Design, Knee Joint Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Jewish General Hospital, McGill University, Zimmer Biomet, Montreal General Hospital
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Sep 2018 (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.
Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.
Detailed description
This is a prospective, double-blinded, randomized control study comparing the TKA Zimmer Medial Pivot Persona design to the traditional Zimmer Persona Knee-PS. Eighty patients requiring a TKA will be recruited and randomized to one of the two treatment arms following confirmation of eligibility criteria. Forty age and sex matched healthy participants with no knee OA will also be recruited to provide a comparator measure of "normal" joint motion.
Clinical follow-up visits and radiographic assessments will be performed pre- and post-operative at 6-weeks, 1-year, 2-years. Knee kinematics and self-assessment will be completed at the following intervals: pre-operative as baseline assessments for knee motion, 1-year, 2-years. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity. Any other adverse events and complications (i.e, implant failure, re-operation, infection) will be record throughout the study.
Healthy participants will only be assessed once to provide normative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, double-blinded, randomized control study consisting of a clinical follow-up followed by a knee kinematics assessment. Patients outcomes will be measured pre-operatively, and at 1 and 2 years post-surgery. Measures will include joint mechanics and neuromuscular activation during walking and stair stepping measured with motion capture and electromyography, and clinical/self assessment including pain in response to physical activity.
| Arm | Type | Receives |
|---|---|---|
| Zimmer MP Persona | Experimental | Device: Zimmer MP PersonaZimmer MP Persona is total knee prosthesis intended to resurface the articulating surface of the femoral, tibial and patellar bones. It employs modular components between the tibial plates and articular surfaces and a medial congruent bearing manufactured from Vivacit-E Highly Crosslinked Polyethylene (HXPE). Persona® Medial Congruent Bearing is available in several sizes and offers up to a 13mm anterior lip height to provide greater anterior constraint and subluxation resistance. Can be used with a with both cruciate retaining and posterior stabilized femoral provisionals |
| Zimmer Persona Knee-PS | Active comparator | Device: Zimmer Persona Knee-PSZimmer Biomet Persona® Knee-PS is a semiconstrained knee prosthesis that employs modular components between the tibial plates and articular surfaces. The device is intended to resurface the articulating surface of the femoral, tibial and patellar bones. The posterior stabilized (PS) femoral provisionals and components can be used with the PS or constrained posterior stabilized (CPS) bearings provisionals and components when the PCL is deficient and removed.The Persona Femur offers 21 distinct profiles, in 2 mm increments. |
| Healthy Participants | No intervention | –The control group for the kinematic assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with osteoarthritis, who in the opinion of the investigator, are suitable candidates for primary total knee replacement using the devices specified in the protocol;
- Males and females between 18 - 80 years at the time of surgery;
- Individuals who understand the conditions of the study and are willing and able to provide informed consent for participation in the study;
- Individuals who are willing and able to participate for the length of the prescribed term of follow-up;
- Individuals who are willing and able to complete all the assessments specified by the study protocol.
Key exclusion criteria (4 listed)
- The presence of previous failed lower extremity arthroplasty or metalwork in situ;
- Patients with severe hip osteoarthritis;
- Patients with lower extremity trauma requiring surgery within 1 year;
- Patients with inflammatory arthritis, severe neurological conditions, or severe cardiovascular conditions.
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 |
|---|---|---|
| Zimmer MP PersonaAlso: Medial Pivot Persona, Persona knee implant with a Medial Congruent BearingThe medial pivot Persona® knee implant with a Medial Congruent™ Bearing | Device | Zimmer MP Persona |
| Zimmer Persona Knee-PSPersona the personalized knee system | Device | Zimmer Persona Knee-PS |
Primary outcome
Knee mechanics
Time frame: pre-operative (as baseline) and at 1 and 2 years following TKA
nee motion will be assessed using 3-dimensional optical motion capture sampled at 100 Hz, floor and step mounted force plates sampled at 2000 Hz, and wireless 16-channel electromyography (EMG) system sampled at 2000 Hz. Knee motion trials will require participants to ambulate at self-selected speeds over 8 meters followed by complete step up/down trials on a 20 cm step. For step up, the surgical limb will be placed on the step to start while for step down, both limbs will start on the step. The order of step up and down trials will be randomized. Participants will perform 2 practice trials followed by testing. Testing will proceed until 5 successful trials of each activity are collected. They will be allowed 30 seconds of rest between trials. The primary motion capture variables will include principal component scores that capture changes in range of motion for knee rotation and flexion angles for each activity.
10 secondary outcomes
Muscle activation
Time frame: pre-operative (as baseline) and at 1 and 2 years following TKA
The 30 seconds Chair Test - Physical Function Performance Test
Time frame: at 1 and 2 years following TKA
The Stair Climb Test - Physical Function Performance Test
Time frame: at 1 and 2 years following TKA
The 6 Minutes Walk Test - Physical Function Performance Test
Time frame: at 1 and 2 years following TKA
Knee Osteoarthritis and Outcome Score (KOOS) Self-Evaluation Questionnaire for Implant Performance
Time frame: pre-operative (as baseline) and at 1 and 2 years following TKA
EQ-5D-5L Self-Evaluation Questionnaire for Implant Performance
Time frame: pre-operative (as baseline) and at 1 and 2 years following TKA
Global Rating of Change (GRC) Self-Evaluation Questionnaire for Implant Performance
Time frame: pre-operative (as baseline) and at 1 and 2 years following TKA
Sensitivity to Physical Activity
Time frame: at 1 and 2 years following TKA
Radiographs
Time frame: pre-operatively, intra operatively and at 6 weeks, 1 year and 2 years post-operatively
Adverse Events
Time frame: intra operatively and at 6 weeks, 1 year and 2 years post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- 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.
John Antoniou, MD, PhD principal investigator
Jewish General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer MP Persona and Zimmer Persona Knee-PS in people with Osteoarthritis, Knee, run by Lady Davis Institute at 3 sites in Canada.
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 5 inclusion and 4 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee mechanics (time frame: pre-operative (as baseline) and at 1 and 2 years following TKA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.