Arthroplasty, Replacement, KneeNCT03088748
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
An observational study of Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by The University of Tennessee, Knoxville at 4 sites in United States.
Trial summary
The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith \& Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
- What is being tested?
- Journey II posterior cruciate retaining total knee arthroplasty and Journey II posterior bi-cruciate retaining total knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to 9 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with a Smith \& Nephew Journey II posterior cruciate retaining (PCR) or a Smith \& Nephew Journey II bi-cruciate retaining (BCR) total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.
Who may be able to join
- Must have must either a Smith \& Nephew Journey II PCR or BCR TKA
- Must be at least three months post-operative
- Must have a Knee Society score of >90 with no ligamentous laxity or pain
- Weigh 250 pounds or less
- Should have good-to-excellent post-operative flexion
- Must be able to perform activities (without aid of any kind) and without pain, walking up and down a ramp, performing a deep knee bend and rising from that kneeling position after the deep knee bend
Show all 10Show fewer
- Must not have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
- Must have body mass index (BMI) of less than 38
- Must be between 40-85 years of age
- Must be willing to sign the Informed Consent (IC) / HIPAA and PHI Release forms 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 the required types of knee implants
- Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
- Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Erlanger Health System
Chattanooga, Tennessee, 34703
Tennessee Foundation for Education and Research
Knoxville, Tennessee, 37923
Tennessee Orthopaedic Clinic
Knoxville, Tennessee, 37923
The University of Tennessee
Knoxville, Tennessee, 37996
About this study
The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith \& Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith \& Nephew BCS TKA and compared these kinematics data to those of normal knees.
Read the detailed description
The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew Journey II BCS TKA.
- Being tested
- Journey II posterior cruciate retaining total knee arthroplasty, Journey II posterior bi-cruciate retaining total knee arthroplasty
- Keywords
- 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.
Journey II posterior cruciate retaining total knee arthroplastyDevice
Also called Journey II PCR TKA
Journey II posterior bi-cruciate retaining total knee arthroplastyDevice
Also called Journey II BCR TKA
| Study group | Role | What they receive |
|---|---|---|
| Smith & Nephew Journey II PCR TKA | Subjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty Receives: Device: Journey II posterior cruciate retaining total knee arthroplasty | |
| Smith & Nephew Journey II BCR TKA | Subjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty Receives: Device: Journey II posterior bi-cruciate retaining total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Kinematics Translations While Ascending Ramp
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking up a ramp. 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 ramp 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 Kinematics Translations While Ascending Ramp
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking up a ramp. 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 ramp 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
Axial Rotation While Ascending Ramp
Femorotibial axial rotation during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation 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 Kinematics Translations While Descending Ramp
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking down a ramp. 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 ramp down). 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 Kinematics Translations While Descending Ramp
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking down a ramp. 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 ramp down). 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
Axial Rotation While Descending Ramp
Femorotibial axial rotation during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation 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 Kinematics Translations During Deep Knee Bend
Anterior Posterior (AP) translations of lateral femoral condyles during a deep knee bend. 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 Kinematics Translations During Deep Knee Bend
Anterior Posterior (AP) translations of medial femoral condyles during a deep knee bend. 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
Axial Rotation During Deep Knee Bend
Femorotibial axial rotation during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) 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 external rotation of the femur, and negative represents internal rotation 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
Maximum Flexion During Deep Knee Bend
Maximum weight-bearing femorotibial flexion during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial range of motion) 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 values are the only possible values in this case, representing the magnitude of weight-bearing flexion. 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 posted23 Mar 2017
- Study startJan 2017
- Primary completion9 Nov 2020
- Study completion9 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
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Richard Komistek, Principal investigator, The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088748
- Sponsor's protocol ID
- 3187FB WIRB20180745
- Status last verified
- Oct 2021
- First submitted
- 16 Mar 2017
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
- Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
- ClinicalTrials.gov ID
- NCT03088748
- Acronym / sponsor ID
- 3187FB WIRB20180745
- Keywords
- total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 23 Mar 2017 (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.
The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with the Smith \& Nephew Journey II posterior cruciate retaining (PCR) total knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously collected data for the Smith \& Nephew BCS TKA and compared these kinematics data to those of normal knees.
Detailed description
The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew Journey II BCS TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smith & Nephew Journey II PCR TKA | – | Device: Journey II posterior cruciate retaining total knee arthroplastySubjects implanted with a Smith \& Nephew Journey II posterior cruciate retaining total knee arthroplasty |
| Smith & Nephew Journey II BCR TKA | – | Device: Journey II posterior bi-cruciate retaining total knee arthroplastySubjects implanted with a Smith \& Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a Smith \& Nephew Journey II posterior cruciate retaining (PCR) or a Smith \& Nephew Journey II bi-cruciate retaining (BCR) total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.
Key inclusion criteria (10 listed)
- Must have must either a Smith \& Nephew Journey II PCR or BCR TKA
- Must be at least three months post-operative
- Must have a Knee Society score of >90 with no ligamentous laxity or pain
- Weigh 250 pounds or less
- Should have good-to-excellent post-operative flexion
Key exclusion criteria (4 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 types of knee implants
- Subjects who are unable to walk up and down a ramp, perform a deep knee bend or rising from that kneeling position without aid or support and without pain
- Subjects who have had other surgical procedures conducted within the past six months that will prohibit them from performing the study activities
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 |
|---|---|---|
| Journey II posterior cruciate retaining total knee arthroplastyAlso: Journey II PCR TKA | Device | Smith & Nephew Journey II PCR TKA |
| Journey II posterior bi-cruciate retaining total knee arthroplastyAlso: Journey II BCR TKA | Device | Smith & Nephew Journey II BCR TKA |
Primary outcome
Lateral Kinematics Translations While Ascending Ramp
Time frame: Baseline
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking up a ramp. 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 ramp 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 Kinematics Translations While Ascending Ramp
Time frame: Baseline
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking up a ramp. 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 ramp 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.
Axial Rotation While Ascending Ramp
Time frame: Baseline
Femorotibial axial rotation during activity of walking up a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp up). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation 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 Kinematics Translations While Descending Ramp
Time frame: Baseline
Anterior Posterior (AP) translations of lateral femoral condyles during activity of walking down a ramp. 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 ramp down). 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 Kinematics Translations While Descending Ramp
Time frame: Baseline
Anterior Posterior (AP) translations of medial femoral condyles during activity of walking down a ramp. 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 ramp down). 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.
Axial Rotation While Descending Ramp
Time frame: Baseline
Femorotibial axial rotation during activity of walking down a ramp. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) during the specified activity (in this case a ramp down). The kinematics (motion) is measured from the beginning of the activity to the end of the activity. Positive represents external rotation of the femur, and negative represents internal rotation 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 Kinematics Translations During Deep Knee Bend
Time frame: Baseline
Anterior Posterior (AP) translations of lateral femoral condyles during a deep knee bend. 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 Kinematics Translations During Deep Knee Bend
Time frame: Baseline
Anterior Posterior (AP) translations of medial femoral condyles during a deep knee bend. 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.
Axial Rotation During Deep Knee Bend
Time frame: Baseline
Femorotibial axial rotation during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial axial rotation) 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 external rotation of the femur, and negative represents internal rotation 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.
Maximum Flexion During Deep Knee Bend
Time frame: Baseline
Maximum weight-bearing femorotibial flexion during a deep knee bend. Data represents the motion of a specific part of the femur bone (in this case femorotibial range of motion) 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 values are the only possible values in this case, representing the magnitude of weight-bearing flexion. 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 principal investigator
The University of Tennessee
4 sites in 1 country: 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 4 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 4 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 4 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 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 Kinematics Translations While Ascending Ramp (time frame: Baseline). The study lists 10 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.