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

NCT07191067 | Recruiting FDA Device

• 1 other identifier: 1-25-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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

Pain

Outcome Measures

Primary Outcomes (1)

• Worst Pain at Day 10

  The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)

  10 days post-TKA

Secondary Outcomes (1)

• Total morphine equivalents used

  5 days post-TKA

Study Arms (2)

NOVABLOC Stimulation

ACTIVE COMPARATOR

Subjects will receive NOVABLOC stimulation prior to their TKA

Device: Percutaneous radiofrequency electrical nerve stimulation

Sham Stimulation

SHAM COMPARATOR

Subject will receive sham non-therapeutic stimulation

Device: Non-therapeutic stimulation

Interventions

Percutaneous radiofrequency electrical nerve stimulation DEVICE

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

NOVABLOC Stimulation

Non-therapeutic stimulation DEVICE

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

Sham Stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant females age ≥ 21 years of age;
• Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;
• Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);
• Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.
• Able to read and understand instructions and information presented in English.

You may not qualify if:

• Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;
• Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;
• History of substance abuse or misuse;
• History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);
• Prior radiofrequency ablation or cryotherapy for pain on the operative knee;
• Prior TKA on the operative knee;
• BMI \> 40;
• History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;
• Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator);
• History of hip or knee dislocation or bone fractures on the operative leg;
• Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;
• Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \>10) or depression (PHQ-9 score \>15);
• Pregnant, actively planning a pregnancy or breast-feeding a child;
• Uncontrolled diabetes (A1C \> 7.5%);
• History of bleeding disorder;

Sponsors & Collaborators

• Synaptrix, Inc.: lead

Study Sites (4)

Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center

Daphne, Alabama, 36526, United States

RECRUITING

Premier Orthopaedic and Trauma Specialists

Upland, California, 91786, United States

NOT YET RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Guerrero

CONTACT

612-227-1483; dan.guerrero@synaptrix.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 24, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (4)