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Departure of study surgeon investigator.
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The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Spinal Surgery | Active Comparator | Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. |
|
| Sensor Guided Spinal Surgery | Experimental | The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Surgery | Procedure | TKA under standard of care spinal surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) | The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | Month 12 Post-Surgery |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems. | Month 12 Post-Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Hertling, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Spinal Surgery | Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. Spinal Surgery: TKA under standard of care spinal surgery. |
| FG001 | Sensor Guided Spinal Surgery | The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. Verasense Knee System device: Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study personnel involved in data collection did not log information on patients in the Standard of Care Spinal Surgery Arm into the study's shared drive. These personnel have since departed from the institution. All efforts by the study team to obtain this information/contact the departed personnel have been unsuccessful. The Principal Investigator believes these missing data to be permanently unavailable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Spinal Surgery | Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. Spinal Surgery: TKA under standard of care spinal surgery. |
| BG001 | Sensor Guided Spinal Surgery |
| 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 | Knee Society Score (KSS) | The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | This study was interrupted as the surgeon investigator decided to retire from clinical practice. Following the surgeon investigator's assessment, no intervention was performed based on the intra-operative results of the pressure load measurement. For that reason, the PI deemed the study team should not compare the surgical results using the KSS. Therefore, this measure was not assessed among study participants; no data are available for this outcome measure as it was not assessed. | Posted | Month 12 Post-Surgery |
|
1 year.
Assessments performed by study personnel and surgical team while in the hospital; then assessments performed by surgeon at scheduled follow-up visits
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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 | Standard of Care Spinal Surgery | Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. Spinal Surgery: TKA under standard of care spinal surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arthur Hertling | NYU Langone Health | 2125986085 | Arthur.Hertling@nyulangone.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Aug 14, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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This is a randomized prospective study looking at the impact sensor guidance has on the outcome of patients and comparing to that of patients with a standard technique.
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| Verasense Knee System device |
| Device |
Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. |
|
|
The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.
Verasense Knee System device: Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Standard of Care Spinal Surgery | Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. Spinal Surgery: TKA under standard of care spinal surgery. |
| OG001 | Sensor Guided Spinal Surgery | The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. Verasense Knee System device: Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. |
|
| Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems. | This study was interrupted as the surgeon investigator decided to retire from clinical practice. Following the surgeon investigator's assessment, no intervention was performed based on the intra-operative results of the pressure load measurement. For that reason, the PI deemed the study team should not compare the surgical results using the KOOS. Therefore, this measure was not assessed among study participants; no data are available for this outcome measure as it was not assessed. | Posted | Month 12 Post-Surgery |
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Sensor Guided Spinal Surgery | The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. Verasense Knee System device: Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. | 0 | 26 | 0 | 26 | 0 | 26 |
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