A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

Not Applicable

Terminated

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

Recruitment & Eligibility

Inclusion Criteria

Age 18 or older
Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria

Pregnant or contemplating pregnancy prior to surgery;
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)
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)
Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): Virtua Joint Replacement Institute
🇺🇸
Voorhees, New Jersey, United States
Virtua Joint Replacement Institute
🇺🇸Voorhees, New Jersey, United States