Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
TKA using Exactech GPS Newton Knee protocol
TKA using manual instrumentation
Kaplan Joint Center, Newton Wellesley Hospital
Newton, Massachusetts, United States
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire
The OKS is a patient reported questionnaire that measures function and pain with a single score.
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire
The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient recovery from TKA using time from hospital stay to discharge
The time of in-patient hospital stay will be measured (in hours).
Time frame: Post-op measure in hours
Patient recovery from TKA by measuring number of outpatient visits
Number of outpatient visits (scheduled and unscheduled)
Time frame: One year post-op
Patient recovery from TKA by measuring number of PT visits
Number of post-op PT visits
Time frame: One year post-op
Patient recovery from TKA by measuring medication consumption
Post-op, prescription medication will be recorded in number of pills and dosage
Time frame: One year post-op
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Patient recovery from TKA by measuring use of assisted walking devices
Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.
Time frame: One year post-op
Knee alignment and soft tissue balance
Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively.
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Knee alignment and soft tissue balance
Patients receiving a TKA NewtonTM Knee, soft-tissue balance will be measured intra-operatively by placing the Newton distractor at the trial reduction stage and acquiring the corresponding joint laxities through the arc of motion.
Time frame: One time (during surgery)