Total Knee ArthroplastyNCT02204748
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System
An observational study of Total Knee Arthroplasty and Osteoarthritis, run by The University of Tennessee, Knoxville at 2 sites in United States.
Trial summary
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Osteoarthritis
- What is being tested?
- DePuy Attune posterior stabilizing fixed bearing knee system
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Aug 2015
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.
Who may be able to join
- At least three (3) months post-operative with no other surgical procedures conducted within the past six months
- Between 30-80 years of age
- Body weight of less than 280 lbs
- Must be between 160cm (5'3) and 193cm (6'4) tall
- Body Mass Index (BMI) >18.5 and <35
- Judged clinically successful with a Knee Society score (KSS) of greater than 80
Show all 10Show fewer
- Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
- Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
- Will have a DePuy Attune PS TKA
- Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study
Who cannot join
- Pregnant or potentially pregnant females will be excluded from the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
The University of Tennessee
Knoxville, Tennessee, 37996
About this study
Official title: Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there is no hypothesis.
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Being tested
- DePuy Attune posterior stabilizing fixed bearing knee system
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Attune posterior stabilizing fixed bearing knee systemDevice
| Study group | Role | What they receive |
|---|---|---|
| DePuy Attune PS FB TKA | Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. Receives: Device: DePuy Attune posterior stabilizing fixed bearing knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Measured: 3 months post-operative
Femoro-tibial Kinematics: Translation and Lift-off for Gait
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Measured: 3 months post-operative
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
Measured: 3 months post-operative
Femoro-tibial Kinematics - Deep Knee Bend
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Measured: 3 months post-operative
Femoro-tibial Kinematics - Gait
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Measured: 3 months post-operative
Femoro-tibial Kinematics - Ramp Down
Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
Measured: 3 months post-operative
Secondary outcomes (3)
Max Ground Reaction Force - Deep Knee Bend
Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
Measured: 3 months post-operative
Max Ground Reaction Force - Gait
Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
Measured: 3 months post-operative
Max Ground Reaction Force - Ramp Down
Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed "maximum reaction force."
Measured: 3 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 posted30 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionAug 2015
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Adrija Sharma, Ph. D., Principal investigator, University of TennesseeWilliam R Hamel, Ph. D., Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204748
- Sponsor's protocol ID
- 13002
- Other IDs
- R011373503
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2014
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02204748
- Acronym / sponsor ID
- 13002
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 4 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there is no hypothesis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy Attune PS FB TKA | – | Device: DePuy Attune posterior stabilizing fixed bearing knee systemIndividuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas Fehring of OrthoCarolina, PA in Charlotte, NC.
Key inclusion criteria (10 listed)
- At least three (3) months post-operative with no other surgical procedures conducted within the past six months
- Between 30-80 years of age
- Body weight of less than 280 lbs
- Must be between 160cm (5'3) and 193cm (6'4) tall
- Body Mass Index (BMI) >18.5 and <35
Key exclusion criteria (1 listed)
- Pregnant or potentially pregnant females will be excluded from the study
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 |
|---|---|---|
| DePuy Attune posterior stabilizing fixed bearing knee system | Device | DePuy Attune PS FB TKA |
Primary outcome
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
Time frame: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics: Translation and Lift-off for Gait
Time frame: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
Time frame: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
Femoro-tibial Kinematics - Deep Knee Bend
Time frame: 3 months post-operative
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics - Gait
Time frame: 3 months post-operative
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics - Ramp Down
Time frame: 3 months post-operative
Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
3 secondary outcomes
Max Ground Reaction Force - Deep Knee Bend
Time frame: 3 months post-operative
Max Ground Reaction Force - Gait
Time frame: 3 months post-operative
Max Ground Reaction Force - Ramp Down
Time frame: 3 months post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adrija Sharma, Ph. D. principal investigator
University of Tennessee
William R Hamel, Ph. D. principal investigator
University of Tennessee
2 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 Osteoarthritis, run by The University of Tennessee, Knoxville at 2 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 10 inclusion and 1 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 4 Feb 2016). 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?
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend (time frame: 3 months post-operative). The study lists 6 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 10 Oct 2019.