Total Knee ArthroplastyTKANCT04113785
In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)
An observational study of Total Knee Arthroplasty and Osteo Arthritis Knee, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. 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 Implant
- What is being tested?
- Klassic Knee System
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 5 Jun 2019
- 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 of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System
Who may be able to join
- Subjects will have a Klassic knee system.
- Subjects must be at least six months post-operative.
- Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
- Participants must be able to perform a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- Must speak English.
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 the required type of knee implant.
- Bilateral subjects (i.e., patients with both knees implanted)
- Subjects who are unable to perform a deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- Subjects who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Hofmann Arthritis Institute for Precision Joint Replacement
Salt Lake City, Utah, 84102
About this study
Official title: In Vivo Kinematics for Subjects Implanted With Klassic TKA
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.
Read the detailed description
Enrollment will be increased to 24 subjects 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. At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off
- Being tested
- Klassic Knee System
- Keywords
- total knee arthroplasty, knee implant, osteoarthritis
- Medical subject headings
- Knee Injuries, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klassic Knee SystemDevice
At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee
| Study group | Role | What they receive |
|---|---|---|
| Klassic TKA | Subjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported. Receives: Device: Klassic Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Rotation (AR) During Deep Knee Bend
Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.
Measured: at least 6 months post-operative
Maximum Weight-bearing Flexion During Deep Knee Bend
Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.
Measured: at least 6 months post-operative
Medial Condyle Translations During Deep Knee Bend Activity.
Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Measured: at least 6 months post-operative
Lateral Condyle Translations During Deep Knee Bend Activity
Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
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 posted3 Oct 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2018
- Study completion5 Jun 2019
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 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Hofmann Arthritis Institute, Duke University
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Richard Komistek, Ph.D., Principal investigator, The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113785
- Sponsor's protocol ID
- WIRB20182087
- Acronym
- TKA
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 15 Nov 2019
- 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 by the secure server after data are uploaded.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Kinematics for Subjects Implanted With Klassic TKA
- ClinicalTrials.gov ID
- NCT04113785
- Acronym / sponsor ID
- TKA / WIRB20182087
- Keywords
- total knee arthroplasty, knee implant, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Hofmann Arthritis Institute, Duke University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 15 Nov 2019
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 a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.
Detailed description
Enrollment will be increased to 24 subjects 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. At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Klassic TKA | – | Device: Klassic Knee SystemSubjects implanted with a Klassic TKA. Subjects will undergo flouoroscopic evaluation during a deep knee bend evaluation and the postoperative kinematics will be reported. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Dr. Aaron Hofmann who have been implanted with the Klassic Knee System
Key inclusion criteria (6 listed)
- Subjects will have a Klassic knee system.
- Subjects must be at least six months post-operative.
- Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than 80.
- Participants must be able to perform a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
Key exclusion criteria (6 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 the required type of knee implant.
- Bilateral subjects (i.e., patients with both knees implanted)
- Subjects who are unable to perform a deep knee bend.
- Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
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 |
|---|---|---|
| Klassic Knee SystemAt present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee | Device | Klassic TKA |
Primary outcome
Axial Rotation (AR) During Deep Knee Bend
Time frame: at least 6 months post-operative
Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.
Maximum Weight-bearing Flexion During Deep Knee Bend
Time frame: at least 6 months post-operative
Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.
Medial Condyle Translations During Deep Knee Bend Activity.
Time frame: at least 6 months post-operative
Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Lateral Condyle Translations During Deep Knee Bend Activity
Time frame: at least 6 months post-operative
Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- 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 by the secure server after data are uploaded.
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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
1 site 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 1 site 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 6 inclusion and 6 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 15 Nov 2019. 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 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?
Yes. Results are posted in the registry (first posted 15 Nov 2019). 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?
Axial Rotation (AR) During Deep Knee Bend (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 15 Nov 2019.