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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Participants who have been implanted with a Smith & Nephew Journey II BCS TKA |
| |
| Journey II Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II CR TKA |
| |
| Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II BCR TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Device | Participants have previously undergone a total knee replacement surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Femorotibial Medial Condylar Rollback | The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Baseline, at time of observation |
| Femorotibial Lateral Condylar Rollback | The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Baseline, at time of observation |
| Femorotibial Axial Rotation | The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Baseline, at time of observation |
| Femorotibial Weight Bearing Flexion | The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Baseline, at time of observation |
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Inclusion Criteria:
Exclusion Criteria:
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All participants will be selected by their respective surgeons. Participants will be screened by eligible surgeon staff and will have the required implant for each site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee | Knoxville | Tennessee | 37996 | United States |
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One knee analyzed per participant
Subjects recruited from surgeon's previously implanted population
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| ID | Title | Description |
|---|---|---|
| FG000 | Journey II Bi-Cruciate Stabilized | Participants who have been implanted with a Smith & Nephew Journey II BCS TKA |
| FG001 | Journey II Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II CR TKA |
| FG002 | Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II BCR TKA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Surgeon-specific techniques and recruitment
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| ID | Title | Description |
|---|---|---|
| BG000 | Journey II Bi-Cruciate Stabilized | Participants who have been implanted with a Smith & Nephew Journey II BCS TKA |
| BG001 | Journey II Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II CR TKA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Femorotibial Medial Condylar Rollback | The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Posted | Mean | Standard Deviation | mm | Baseline, at time of observation |
|
This is a single-day observational study. Participants were not followed over a period of time, and they were not given any intervention. Adverse event would only happen during data collection, such as participants falling or radiation exposure that exceeded the IRB-approved time limit of 2 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Journey II Bi-Cruciate Stabilized | Participants who have been implanted with a Smith & Nephew Journey II BCS TKA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael LaCour | University of Tennessee | 865-974-4159 | mlacour@utk.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2020 | Apr 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| BG002 | Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II BCR TKA |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II BCR TKA |
|
|
| Primary | Femorotibial Lateral Condylar Rollback | The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [mm]. | Posted | Mean | Standard Deviation | mm | Baseline, at time of observation |
|
|
|
| Primary | Femorotibial Axial Rotation | The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Posted | Mean | Standard Deviation | degrees | Baseline, at time of observation |
|
|
|
| Primary | Femorotibial Weight Bearing Flexion | The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in [deg]. | Posted | Mean | Standard Deviation | degrees | Baseline, at time of observation |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Journey II Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II CR TKA | 0 | 71 | 0 | 71 | 0 | 71 |
| EG002 | Journey II Bi-Cruciate Retaining | Participants who have been implanted with a Smith & Nephew Journey II BCR TKA | 0 | 29 | 0 | 29 | 0 | 29 |
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| Male |
|