Recruiting

NOVABLOC TKANOVABLOC System for Pain and Recovery in Knee Replacement Patients

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What is being tested

Percutaneous radiofrequency electrical nerve stimulation

+ Non-therapeutic stimulation

Device
Who is being recruted

Neurologic Manifestations+1

+ Pain

+ Signs and Symptoms

Over 21 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorSynaptrix, Inc.
Study ContactDaniel Guerrero
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual 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
NCT07191067
Principal SponsorSynaptrix, Inc.
Study ContactDaniel Guerrero
Last updated: January 28, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Secondary Objectives

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 Center

Daphne, United StatesOpen Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center in Google Maps
Recruiting
One Study Center