TerminatedNot Applicable

A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

Stopped: Insufficient research coordinating support to continue recruitment and data collection

United States92 participantsStarted 2018-04-20

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Patient Reported Forgotten Joint Score (FJS)

Timeframe: 1 year

Trial details

NCT IDNCT03523897

SponsorVirtua Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-14

Results submitted2023-09-18

View on ClinicalTrials.gov More Primary Osteoarthritis of Knee Nos trials