Recruiting
NOVABLOC TKA

NOVABLOC System for Pain and Recovery in Knee Replacement Patients

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What is being tested

Pulsed radiofrequency

+ Non-therapeutic stimulation
Device
Who is being recruted

Pain

Over 21 Years
+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled
Phase 2
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorSynaptrix, Inc.
Study ContactDaniel Guerrero
Last updated: October 20, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 30, 2025Actual date on which the first participant was enrolled.

This study focuses on patients who are having knee replacement surgery, known as Total Knee Arthroplasty (TKA). It aims to evaluate the safety and effectiveness of a system called NOVABLOC in helping manage pain, improving functional recovery, and reducing the need for opioid painkillers after surgery. This research is important because managing pain effectively after surgery can help patients recover faster and reduce the reliance on opioids, which have significant side effects and potential for addiction. Participants in this study are randomly assigned to one of two groups. One group receives the actual NOVABLOC system, while the other group receives a sham treatment, meaning they do not get the real device but think they might be. This helps researchers compare the outcomes accurately. The study measures how well the NOVABLOC system controls pain, aids recovery, and affects opioid use after surgery. Safety is also closely monitored to ensure the treatment does not cause harm. The study is conducted in a blinded manner, meaning neither the participants nor the researchers know who receives which treatment, to ensure unbiased results.

Official TitleA Multi-Center Two-Arm, Randomized, Blinded, Sham-Controlled Trial to Determine the Safety and Efficacy of the NOVABLOC System on Postoperative Pain, Functional Recovery and Opioid Use in Patients Undergoing Primary Total Knee Arthroplasty 
Principal SponsorSynaptrix, Inc.
Study ContactDaniel Guerrero
Last updated: October 20, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pain
Criteria
5 inclusion criteria required to participate
Male or non-pregnant females age ≥ 21 years of age
Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines
Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI)
Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days

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16 exclusion criteria prevent from participating
Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure
Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure
History of substance abuse or misuse
History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Subjects will receive NOVABLOC stimulation prior to their TKA
Group II
Sham
Subject will receive sham non-therapeutic stimulation
Study Objectives
Primary Objectives

The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)
Secondary Objectives

Total morphine equivalents used cumulatively through Day 5

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Alabama Orthopedic Sports Medicine & Baldwin County Surgery CenterDaphne, United StatesSee the location
Recruiting
One Study Center