Arthroplasty, Replacement, KneePCR PS TKANCT04103515
Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by The University of Tennessee, Knoxville at 3 sites in 2 countries.
Trial summary
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
- What is being tested?
- Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty and Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Jan 2019to 6 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients implanted with a Zimmer-Biomet posterior cruciate retaining (PCR) or Zimmer-Biomet posterior stabilizing total knee arthroplasty (TKA)
Who may be able to join
- Subjects will have a Zimmer Persona PCR or PS TKA.
- Subjects must be at least six months post-operative.
- Subjects will have KSS greater than 75.
- Participants must be able to perform the required activities - stepping up and a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- Bilateral subjects may be included in the subject population
Who cannot join
- Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
- Subjects without the required type of knee implant.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who do not speak English and/or French
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Rothman Institute
Bryn Mawr, Pennsylvania, 19010
University of Tennessee
Knoxville, Tennessee, 37996
France1 site
The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite
Marseille, 13009
About this study
Official title: In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.
- Being tested
- Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty, Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
- 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-Biomet Posterior Cruciate Retaining total knee arthroplastyDevice
Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
Zimmer-Biomet Posterior Stabilizing total knee arthroplastyDevice
Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Subjects implanted with PCR TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty Receives: Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty | |
| Subjects implanted with PS TKA | Subjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty Receives: Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Condyle Kinematic Translations - Step up
Lateral Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Measured: Baseline
Lateral Condyle Kinematics Translations - Deep Knee Bend
Lateral Condyle Kinematics Translations during deep knee bend activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Measured: Baseline
Medial Condyle Kinematics Translations - Step Up
Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Measured: Baseline
Medial Condyle Kinematics Translations - Deep Knee Bend
Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start3 Jan 2019
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Richard Komistek, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103515
- Sponsor's protocol ID
- WIRB20183083
- Acronym
- PCR PS TKA
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2019
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA
- ClinicalTrials.gov ID
- NCT04103515
- Acronym / sponsor ID
- PCR PS TKA / WIRB20183083
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects implanted with PCR TKA | – | Device: Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplastySubjects who have been implanted with a Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty |
| Subjects implanted with PS TKA | – | Device: Zimmer-Biomet Posterior Stabilizing total knee arthroplastySubjects who have been implanted with a Zimmer-Biomet Posterior Stabilizing total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a Zimmer-Biomet posterior cruciate retaining (PCR) or Zimmer-Biomet posterior stabilizing total knee arthroplasty (TKA)
Key inclusion criteria (6 listed)
- Subjects will have a Zimmer Persona PCR or PS TKA.
- Subjects must be at least six months post-operative.
- Subjects will have KSS greater than 75.
- Participants must be able to perform the required activities - stepping up and a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
Key exclusion criteria (5 listed)
- Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
- Subjects without the required type of knee implant.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who do not speak English and/or French
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-Biomet Posterior Cruciate Retaining total knee arthroplastyZimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty | Device | Subjects implanted with PCR TKA |
| Zimmer-Biomet Posterior Stabilizing total knee arthroplastyZimmer-Biomet Posterior Stabilizing total knee arthroplasty | Device | Subjects implanted with PS TKA |
Primary outcome
Lateral Condyle Kinematic Translations - Step up
Time frame: Baseline
Lateral Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Lateral Condyle Kinematics Translations - Deep Knee Bend
Time frame: Baseline
Lateral Condyle Kinematics Translations during deep knee bend activity. Data represents the motion of a specific part of the femur bone (in this case lateral femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Medial Condyle Kinematics Translations - Step Up
Time frame: Baseline
Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a step up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Medial Condyle Kinematics Translations - Deep Knee Bend
Time frame: Baseline
Medial Condyle Kinematics Translations during deep knee bend activity. Medial Condyle Kinematics Translations during stepping up activity. Data represents the motion of a specific part of the femur bone (in this case medial femoral condyle) during the specified activity (in this case a deep knee bend). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents anterior motion of the femur, and negative represents posterior rollback of the femur. Data is only collected at a single time point and therefore refers to the motion of the femur bone during a specific activity at a single point in time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.
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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.
Richard Komistek, PhD principal investigator
University of Tennessee
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by The University of Tennessee, Knoxville at 3 sites in 2 countries.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 12 Oct 2021. 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 United States, France. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lateral Condyle Kinematic Translations - Step up (time frame: Baseline). The study lists 4 primary outcomes in all. 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 Oct 2021.