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

NCT07191067 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Percutaneous radiofrequency electrical nerve stimulation

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

DEVICE

Non-therapeutic stimulation

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

Sponsors & Collaborators

  • Synaptrix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191067 on ClinicalTrials.gov