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Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Sponsor: Synaptrix, Inc.
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
Percutaneous radiofrequency electrical nerve stimulation
Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
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