RecruitingNot ApplicableNCT07191067

Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty

A 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

Sponsor

Synaptrix, Inc.

Enrollment

120 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Pain

Summary

Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Non-therapeutic stimulation and a medical device called Percutaneous radiofrequency electrical nerve stimulation for people with pain. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPercutaneous radiofrequency electrical nerve stimulation

Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.

DEVICENon-therapeutic stimulation

Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.

Locations(5)

Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center

Daphne, Alabama, United States

Premier Orthopaedic and Trauma Specialists

Upland, California, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Southern Oregon Orthopedics

Medford, Oregon, United States

Virginia Mason Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07191067

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