Knee Injuries
Conditions
Keywords
Total Knee Replacement Arthroplasty
Brief summary
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.
Interventions
PROCEDURESpinal Surgery
TKA under standard of care spinal surgery.
DEVICEVerasense 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition. * Patient with chronic knee pain who is indicated for total hip or knee replacement surgery * Patient is at least 50 years of age * Patient is willing to participate in pre- and postoperative surveys
Exclusion criteria
* Failure to complete pre-operative surveys. * Revision Total Knee Arthroplasty * Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy * Contralateral Total Knee Arthroplasty * Prior tibial plateau fracture * Ligamentous Insufficiency * History of fibromyalgia, chronic fatigue syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | Month 12 Post-Surgery | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Month 12 Post-Surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Sensor Guided Spinal Surgery | Total |
|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 7.1 | 71.3 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants |
| Region of Enrollment United States | 26 participants | 26 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
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.
Time frame: Month 12 Post-Surgery
Population: 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.
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.
Time frame: Month 12 Post-Surgery
Population: 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.