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limited eligible population
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This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Revision | A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. |
| |
| Total Revision | A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERASENSE | Procedure | Sensor-Assisted Revision TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cause of Early TKA Revision | The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital. | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated. | 12 months |
| Veterans Rand 12-Item Health Survey |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are candidates for revision TKA and meet all inclusion and no exclusion will be offered study participation without regard to race, sex, economic status, or religious belief.
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| Name | Affiliation | Role |
|---|---|---|
| William Leone, MD | Holy Cross Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital, Orthopedic Institute | Fort Lauderdale | Florida | 33334 | United States |
The investigator decided to terminate the study because the evaluable population required for the study was very limited after only one subject was recruited during the one-year recruitment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Partial Revision | A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. VERASENSE: Sensor-Assisted Revision TKA |
| FG001 | Total Revision | A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). VERASENSE: Sensor-Assisted Revision TKA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No subject was recruited for the "Partial Revision" study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Partial Revision | A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. VERASENSE: Sensor-Assisted Revision TKA |
| BG001 | Total Revision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cause of Early TKA Revision | The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital. | 12 months follow up did not occur due to study termination | Posted | 12-months |
|
Date of inclusion to date of termination up to 6 months
No patient was enrolled to the "partial revision" group.
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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 | Partial Revision | Revision of tibial liner. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Knee pain after patient twisted operated knee |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Barga | Stryker | +12018315073 | Kevin.Barga@stryker.com |
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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 | Jan 9, 2017 | Feb 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| C562456 | Volvulus Of Midgut |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health |
| Change from Baseline at 12-months |
A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). VERASENSE: Sensor-Assisted Revision TKA |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | No data were collected for Sex/Gender | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Knee Society Score | This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated. | No outcome data was analyzed because of study termination before reaching 12 months period | Posted | 12 months |
|
|
| Secondary | Veterans Rand 12-Item Health Survey | This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health | no outcome data was analyzed because of study termination before reaching 12 months period | Posted | Change from Baseline at 12-months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Total Revision | Revision of all components | 0 | 1 | 0 | 1 | 1 | 1 |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Knee pain after patient fell on the operated knee |
|
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| D012216 |
| Rheumatic Diseases |