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Procedure
Newton™ TKA Protocol for Total Knee Replacement
N/A
Waitlist Available
Research Sponsored by Newton-Wellesley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-op
Awards & highlights
No Placebo-Only Group
Summary
This trial compared patient outcomes and recovery after knee replacement surgery using traditional instruments versus a new technique called the Newton TM Knee Protocol.
Who is the study for?
This trial is for patients at the Kaplan Joint Center, Newton Wellesley Hospital who are scheduled to have a total knee replacement (TKA) with a specific implant. It's not open to those with certain medical conditions that could interfere with the study.
What is being tested?
The study compares traditional TKA methods against the Newton™ Knee Protocol, which uses computer navigation and full arc of motion gap balancing to potentially improve patient recovery and clinical outcomes.
What are the potential side effects?
While specific side effects aren't listed, typical risks associated with knee replacement surgery may include pain, swelling, infection risk at the surgical site, blood clots, or issues related to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient recovery from TKA by measuring medication consumption
Patient recovery from TKA by measuring number of PT visits
Patient recovery from TKA by measuring number of outpatient visits
+5 moreSecondary study objectives
Knee alignment and soft tissue balance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigationExperimental Treatment1 Intervention
The intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
Group II: Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentationActive Control1 Intervention
The comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation.
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Who is running the clinical trial?
Newton-Wellesley HospitalLead Sponsor
13 Previous Clinical Trials
4,696 Total Patients Enrolled
ExactechIndustry Sponsor
16 Previous Clinical Trials
30,376 Total Patients Enrolled