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Active, not recruiting Not applicable

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

NCT07191067 · tracked via the Priya Life Science USA tracker
Sponsor
Synaptrix, Inc
Phase
Not applicable
Started
2025-09-30
Last updated
2026-10-26

Condition(s) studied

Pain

Investigational drug(s) / intervention(s)

Percutaneous radiofrequency electrical nerve stimulationNon-therapeutic stimulation

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.

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male or non-pregnant females age ≥ 21 years of age; 2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines; 3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI); 4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days. 5. Able to read and understand instructions and information presented in English. Exclusion Criteria: 1. Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure; 2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure; 3. History of substance abuse or misuse; 4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities); 5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee; 6. Prior TKA on the operative knee; 7. BMI \> 40; 8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions; 9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator); 10. History of hip or knee dislocation or bone fractures on the operative leg; 11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin; 12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \>10) or depression (PHQ-9 score \>15); 13. Pregnant, actively planning a pregnancy or breast-feeding a child; 14. Uncontrolled diabetes (A1C \> 7.5%); 15. History of bleeding disorder; 16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.

Primary outcome measure(s)

  • Worst Pain at Day 10 — 10 days post-TKA
    The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)

Trial sites (5)

FacilityCityRegionStatus
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center Daphne Alabama
UBMD Orthopedics and Sports Medicine Williamsville New York
University of North Carolina Chapel Hill North Carolina
Southern Oregon Orthopedics Medford Oregon
Virginia Mason Medical Center Seattle Washington
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07191067 on ClinicalTrials.gov ↗ ← All trials in the USA