Knee, Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty
Brief summary
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
Detailed description
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.
Interventions
DEVICEJourney II Bi-Cruciate Stabilized TKA
Total Knee Arthroplasty System
DEVICEJourney II Cruciate Retaining TKA
Total Knee Arthroplasty System
DEVICEJourney II Bi-Cruciate Retaining TKA
Total Knee Arthroplasty System
Sponsors
The University of Tennessee, Knoxville
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients in the age range of 18 years to 85 years (both inclusive) 2. Patients who have a BMI less than 35 3. Patients who do not have previous surgery on the implanted knee that might restrict their movement 4. Patient who are at least 6 months post-operative 5. Patients who do not experience any pain or other post-operative complications 6. Patients who have a stable TKA and can perform a deep knee bend activity 7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms 8. Subjects will have a Journey II, either the BCS or XR, knee system
Exclusion criteria
1. 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. 2. Patients who have currently enrolled in a fluoroscopic study within the past year. 3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims. 4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study. 5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability 6. Subjects who are unable to perform a deep knee bend. 7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents. 8. Subjects without the required type of knee implant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medial AP Translations, in mm | At least 6 months postoperative | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. |
| Lateral AP Translations, in mm | At least 6 months postoperative | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. |
| Maximum Flexion, in Degrees | At least 6 months postoperative | Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending. |
| Axial Rotation, in Degrees | At least 6 months postoperative | Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Journey II Bi-Cruciate Stabilized Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected
Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System | 25 |
| Journey II Cruciate Retaining Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained)
Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System | 25 |
| Journey II Bi-Cruciate Retaining Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained
Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System | 10 |
| Total | 60 |
Baseline characteristics
| Characteristic | Journey II Cruciate Retaining | Journey II Bi-Cruciate Retaining | Journey II Bi-Cruciate Stabilized | Total |
|---|---|---|---|---|
| Age, Customized <18 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18-85 | 25 Participants | 10 Participants | 25 Participants | 60 Participants |
| Age, Customized 85+ | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 5 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 10 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 10 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 10 |
Outcome results
Primary
Axial Rotation, in Degrees
Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.
Time frame: At least 6 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Axial Rotation, in Degrees | 7.1 degrees | Standard Deviation 4.2 |
| Journey II Cruciate Retaining | Axial Rotation, in Degrees | 5.6 degrees | Standard Deviation 5.7 |
| Journey II Bi-Cruciate Retaining | Axial Rotation, in Degrees | 6.0 degrees | Standard Deviation 7 |
Primary
Lateral AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Time frame: At least 6 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Lateral AP Translations, in mm | -12.5 millimeters | Standard Deviation 5 |
| Journey II Cruciate Retaining | Lateral AP Translations, in mm | -4.7 millimeters | Standard Deviation 6.2 |
| Journey II Bi-Cruciate Retaining | Lateral AP Translations, in mm | -9.4 millimeters | Standard Deviation 6.1 |
Primary
Maximum Flexion, in Degrees
Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.
Time frame: At least 6 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Maximum Flexion, in Degrees | 108 degrees | Standard Deviation 13 |
| Journey II Cruciate Retaining | Maximum Flexion, in Degrees | 121 degrees | Standard Deviation 6 |
| Journey II Bi-Cruciate Retaining | Maximum Flexion, in Degrees | 105 degrees | Standard Deviation 13 |
Primary
Medial AP Translations, in mm
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Time frame: At least 6 months postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Medial AP Translations, in mm | -6.9 millimeters | Standard Deviation 2.8 |
| Journey II Cruciate Retaining | Medial AP Translations, in mm | -0.2 millimeters | Standard Deviation 4.3 |
| Journey II Bi-Cruciate Retaining | Medial AP Translations, in mm | -4.4 millimeters | Standard Deviation 3.8 |