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

NCT ID: NCT07191067

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

NOVABLOC Stimulation

Subjects will receive NOVABLOC stimulation prior to their TKA

Group Type: ACTIVE_COMPARATOR

Percutaneous radiofrequency electrical nerve stimulation

Intervention Type: DEVICE

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

Sham Stimulation

Subject will receive sham non-therapeutic stimulation

Group Type: SHAM_COMPARATOR

Non-therapeutic stimulation

Intervention Type: DEVICE

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

Interventions

Percutaneous radiofrequency electrical nerve stimulation

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

Intervention Type: DEVICE

Non-therapeutic stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synaptrix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center

Daphne, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Guerrero

Role: CONTACT

dan.guerrero@synaptrix.net

612-227-1483

Facility Contacts

Natalia Alexeeva, PhD

Role: primary

natalex7230@outlook.com

315-395-3300

Other Identifiers

1-25-001

Identifier Type: -

Identifier Source: org_study_id