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RECRUITING
NCT07191067
NA

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

Sponsor: Synaptrix, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-30

Completion Date

2026-03-30

Last Updated

2026-02-27

Healthy Volunteers

No

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.

Locations (4)

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

Virginia Mason Medical Center

Seattle, Washington, United States