NOVABLOC to reduce pain after primary unilateral total knee replacement

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

This trial will test whether the NOVABLOC system can reduce post-operative pain in adults with osteoarthritis undergoing a primary unilateral total knee replacement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Synaptrix, Inc. (industry)
• Locations: 4 sites (Daphne, Alabama and 3 other locations)
• Trial ID: NCT07191067 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, blinded, sham-controlled trial compares percutaneous radiofrequency electrical nerve stimulation using the NOVABLOC system to non-therapeutic (sham) stimulation in patients having primary unilateral total knee arthroplasty for osteoarthritis. Participants are randomized to active or sham treatment and followed for safety and pain outcomes for up to 45 days after surgery. Key eligibility includes adults aged 21 or older with osteoarthritis indicated for primary TKA, while recent chronic high‑dose opioid use and significant cardiac disease are exclusion criteria. The trial collects postoperative pain measures and adverse events to determine whether NOVABLOC provides meaningful pain relief versus sham.

Who should consider this trial

Good fit: Adults aged 21 or older with osteoarthritis scheduled for a primary unilateral total knee replacement who can consent, read English, and are not chronic high‑dose opioid users or have significant cardiac disease are ideal candidates.

Not a fit: Patients with recent chronic high‑dose opioid use, significant cardiac disease, pregnancy, revision or bilateral knee replacements, or inability to attend follow-up visits are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, NOVABLOC could lower post-operative pain after TKA and reduce opioid requirements, potentially speeding recovery.

How similar studies have performed: Peripheral nerve stimulation and percutaneous radiofrequency approaches have shown promise for some pain conditions, but using NOVABLOC in the immediate post-TKA setting is relatively novel.

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.

Where this trial is running

Daphne, Alabama and 3 other locations

• Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center — Daphne, Alabama, United States (RECRUITING)
• Premier Orthopaedic and Trauma Specialists — Upland, California, United States (NOT_YET_RECRUITING)
• University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
• Virginia Mason Medical Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Daniel Guerrero

Conditions: Pain