Primary Osteoarthritis of Knee Nos
Conditions
Brief summary
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include: 1. Patients' self-reported awareness of their artificial joints during activities of daily living; 2. Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life; 3. Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; 4. The accuracy of implant placement and limb alignment
Interventions
PROCEDURERobot Assisted Total Knee Replacement
A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
PROCEDURETraditional Total Knee Replacement
A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
Sponsors
Virtua Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 or older 2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI 3. Willing to provide informed consent, participate in study, and comply with study protocol
Exclusion criteria
1. Pregnant or contemplating pregnancy prior to surgery; 2. Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement) 3. Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups) 4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Forgotten Joint Score (FJS) | 1 year | The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS) | 1 year | The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). |
| Patient Reported Veterans Rand 12-item Health Survey Score (VR-12) | 1 year | The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental 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. |
| The Mechanical Alignment of the Post-operative Limb | 6 weeks postoperatively | The mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robot Assisted Total Knee Replacement In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
Robot Assisted Total Knee Replacement: A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints | 39 |
| Traditional Total Knee Replacement The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
Traditional Total Knee Replacement: A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints | 53 |
| Total | 92 |
Baseline characteristics
| Characteristic | Robot Assisted Total Knee Replacement | Traditional Total Knee Replacement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 53 Participants | 91 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 51 Participants | 89 Participants |
| Region of Enrollment United States | 39 participants | 53 participants | 92 participants |
| Sex: Female, Male Female | 26 Participants | 33 Participants | 59 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Patient Reported Forgotten Joint Score (FJS)
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
Time frame: 1 year
Population: Study canceled due to lack of resources. The personnel responsible for collecting data left the hospital system before any data was collected and the investigators involved did not have the time necessary to collect and organize data. Therefore, no data was collected at the 1-year timeframe, leading to no data available for analysis.
Secondary
Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Time frame: 1 year
Population: Study canceled due to lack of resources. The personnel responsible for collecting data left the hospital system before any data was collected and the investigators involved did not have the time necessary to collect and organize data. Therefore, no data was collected at the 1-year timeframe, leading to no data available for analysis.
Secondary
Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental 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: 1 year
Secondary
The Mechanical Alignment of the Post-operative Limb
The mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared.
Time frame: 6 weeks postoperatively