A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
- Conditions
- Total Knee Arthroplasty
- Registration Number
- NCT06678750
- Lead Sponsor
- Newton-Wellesley Hospital
- Brief Summary
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
- Detailed Description
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®).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant
- Patients may be excluded due to some medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient satisfaction with TKA using patient reported KOOS JR Questionnaire Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op The OKS is a patient reported questionnaire that measures function and pain with a single score.
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op 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.
Patient recovery from TKA using time from hospital stay to discharge Post-op measure in hours The time of in-patient hospital stay will be measured (in hours).
Patient recovery from TKA by measuring number of outpatient visits One year post-op Number of outpatient visits (scheduled and unscheduled)
Patient recovery from TKA by measuring number of PT visits One year post-op Number of post-op PT visits
Patient recovery from TKA by measuring medication consumption One year post-op Post-op, prescription medication will be recorded in number of pills and dosage
Patient recovery from TKA by measuring use of assisted walking devices One year post-op Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.
- Secondary Outcome Measures
Name Time Method Knee alignment and soft tissue balance One time (during surgery) 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.
Trial Locations
- Locations (1)
Kaplan Joint Center, Newton Wellesley Hospital
🇺🇸Newton, Massachusetts, United States