Total Knee ArthroplastyTKA PCRNCT04103502
In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA
An observational study of Total Knee Arthroplasty and Osteo Arthritis Knee, run by The University of Tennessee, Knoxville at 3 sites in United States.
Trial summary
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Osteo Arthritis Knee, Knee Injuries
- What is being tested?
- MicroPort Medial Pivot TKA and DePuy Attune PCR TKA
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2025to 15 Dec 2025
- Phase
- Observational
- 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
Study population: There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion
Who may be able to join
- Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
- Subjects must be at least six months post-operative.
- Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
- 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
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.
- Subjects without one of the two types of knee implants under investigation.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- Does not speak English.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Tennessee
Knoxville, Tennessee, 37934
Nevada Orthopedic & Spine Center
Las Vegas, Nevada, 89128
Platinum Training/MERIN
Las Vegas, Nevada, 89130
About this study
Official title: In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic \& Spine Center [this is the location from which participants will be recruited].
Read the detailed description
There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.
- Being tested
- MicroPort Medial Pivot TKA, DePuy Attune PCR TKA
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPort Medial Pivot TKADevice
Subjects will have been implanted with the MicroPort Medial Pivot TKA
DePuy Attune PCR TKADevice
Subjects will have been implanted with the DePuy Attune PCR TKA
| Study group | Role | What they receive |
|---|---|---|
| MicroPort Medial Pivot | Subjects will have been implanted with the MicroPort Medial Pivot TKA Receives: Device: MicroPort Medial Pivot TKA | |
| DePuy Attune | Subjects will have been implanted with the DePuy Attune PCR TKA Receives: Device: DePuy Attune PCR TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics Translations during Deep Knee Bend Activity
Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend
Measured: at least 6 months post-operative
Kinematics during Deep Knee Bend Activity
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Measured: at least 6 months post-operative
Kinematics Translations during step up activity
Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity
Measured: at least 6 months post-operative
Kinematics during step up activity
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity
Measured: at least 6 months post-operative
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 startMay 2025 (estimated)
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Why it stopped: Funding withdrawn, no participants recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Komistek, Ph.D., Principal investigator, The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103502
- Sponsor's protocol ID
- WIRB20181868
- Acronym
- TKA PCR
- Status last verified
- May 2024
- First submitted
- 23 Sep 2019
- Last updated
- 5 May 2026
- Results posted
- No
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04103502
- Acronym / sponsor ID
- TKA PCR / WIRB20181868
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn, no participants recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Study start
- May 2025 (estimated)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 25 Sep 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.
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic \& Spine Center [this is the location from which participants will be recruited].
Detailed description
There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroPort Medial Pivot | – | Device: MicroPort Medial Pivot TKASubjects will have been implanted with the MicroPort Medial Pivot TKA |
| DePuy Attune | – | Device: DePuy Attune PCR TKASubjects will have been implanted with the DePuy Attune PCR TKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion
Key inclusion criteria (5 listed)
- Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
- Subjects must be at least six months post-operative.
- Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
- 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.
- Subjects without one of the two types of knee implants under investigation.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- Does not speak English.
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 |
|---|---|---|
| MicroPort Medial Pivot TKASubjects will have been implanted with the MicroPort Medial Pivot TKA | Device | MicroPort Medial Pivot |
| DePuy Attune PCR TKASubjects will have been implanted with the DePuy Attune PCR TKA | Device | DePuy Attune |
Primary outcome
Kinematics Translations during Deep Knee Bend Activity
Time frame: at least 6 months post-operative
Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend
Kinematics during Deep Knee Bend Activity
Time frame: at least 6 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Kinematics Translations during step up activity
Time frame: at least 6 months post-operative
Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity
Kinematics during step up activity
Time frame: at least 6 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- 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, Ph.D. principal investigator
The University of Tennessee
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Osteo Arthritis Knee, run by The University of Tennessee, Knoxville at 3 sites in United States.
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 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: withdrawn, as of the sponsor's last update on 5 May 2026. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Kinematics Translations during Deep Knee Bend Activity (time frame: at least 6 months post-operative). 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 5 May 2026.