Knee Osteoarthritis
Conditions
Keywords
Revision TKA, Instability, Stiffness, Aseptic Loosening, Polyethylene Wear, Malrotation, Soft Tissue Imbalance
Brief summary
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.
Interventions
PROCEDUREVERASENSE
Sensor-Assisted Revision TKA
Sponsors
Orthosensor, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure * Include Male and Female subjects * Include subjects 18 years and older * Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation * Patients able to understand study intent, and agree to study participation * Patients must be previously implanted with the following cruciate-retaining (CR) or posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.
Exclusion criteria
* No prior revision surgery on operative side * Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * Culture positive aspiration indicating infection of the joint * ASA class \> III * History of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cause of Early TKA Revision | 12-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 12 months | 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. |
| Veterans Rand 12-Item Health Survey | Change from Baseline at 12-months | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| 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 | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study termination | 0 | 1 |
Baseline characteristics
| Characteristic | Total Revision | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants |
| Sex/Gender, Customized unknown | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 1 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: 12-months
Population: 12 months follow up did not occur due to study termination
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.
Time frame: 12 months
Population: No outcome data was analyzed because of study termination before reaching 12 months period
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
Time frame: Change from Baseline at 12-months
Population: no outcome data was analyzed because of study termination before reaching 12 months period