- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03088748
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
October 11, 2021 updated by: Richard Komistek, The University of Tennessee, Knoxville
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
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Chattanooga, Tennessee, United States, 34703
- Erlanger Health System
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Knoxville, Tennessee, United States, 37996
- The University of Tennessee
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Knoxville, Tennessee, United States, 37923
- Tennessee Foundation for Education and Research
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Knoxville, Tennessee, United States, 37923
- Tennessee Orthopaedic Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Smith & Nephew Journey II PCR TKA
Subjects implanted with a Smith & Nephew Journey II posterior cruciate retaining total knee arthroplasty
|
Other Names:
|
Smith & Nephew Journey II BCR TKA
Subjects implanted with a Smith & Nephew Journey II posterior bi-cruciate retaining total knee arthroplasty
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard Komistek, The University of Tennessee
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
November 9, 2020
Study Completion (ACTUAL)
November 9, 2020
Study Registration Dates
First Submitted
March 16, 2017
First Submitted That Met QC Criteria
March 16, 2017
First Posted (ACTUAL)
March 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 12, 2021
Last Update Submitted That Met QC Criteria
October 11, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3187FB WIRB20180745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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