Total Knee ArthroplastyNCT02613338
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2
An observational study of Total Knee Arthroplasty and Osteoarthritis, run by The University of Tennessee, Knoxville at 5 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
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2015to Jan 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
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 9Show 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
Who cannot join
- Pregnant or potentially pregnant females will be excluded from the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Abercrombie Radiology
Knoxville, Tennessee, 37909
Dougherty Engineering Building, Room M007
Knoxville, Tennessee, 37996
Perkins Hall, The University of Tennessee
Knoxville, Tennessee, 37996
Science and Engineering Research Facility, The University of Tennessee
Knoxville, Tennessee, 37996
About this study
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 continuation of the study will analyze 30 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.
- 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
Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
| Study group | Role | What they receive |
|---|---|---|
| DePuy Attune PS FB knee system | Patients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system 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 - Lateral Anterior/Posterior Motion
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down
Measured: 3 months post-operative
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down
Measured: 3 months post-operative
Femoro-tibial Kinematics - Axial Rotation
Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.
Measured: 3 months post-operative
Femoro-tibial Kinematics - Weight-bearing Flexion
Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.
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 activity was normalized with respect to participant's body weight 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 activity.
was normalized with respect to participant's body weight 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 activity.
was normalized with respect to participant's body weight 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 posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionJan 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- 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
- NCT02613338
- Sponsor's protocol ID
- 9568FB
- Other IDs
- IIS-13002
- Status last verified
- Oct 2019
- First submitted
- 20 Nov 2015
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 Nov 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 With Attune Knee System - Phase 2
- ClinicalTrials.gov ID
- NCT02613338
- Acronym / sponsor ID
- 9568FB
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 12 Nov 2019
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 continuation of the study will analyze 30 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy Attune PS FB knee system | – | Device: DePuy Attune posterior stabilizing fixed bearing knee systemPatients implanted with a DePuy Attune posterior stabilizing fixed bearing knee system |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Key inclusion criteria (9 listed)
- At least three (3) months post-operative with no other surgical procedures conducted within the past six months
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 systemIndividuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative. | Device | DePuy Attune PS FB knee system |
Primary outcome
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
Time frame: 3 months post-operative
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion
Time frame: 3 months post-operative
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Axial Rotation
Time frame: 3 months post-operative
Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.
Femoro-tibial Kinematics - Weight-bearing Flexion
Time frame: 3 months post-operative
Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.
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 12 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 from the database upon entry into the secure server. Data shared with sponsors is de-identified.
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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
5 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 5 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 9 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 12 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 5 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 12 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?
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion (time frame: 3 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 12 Nov 2019.