Status:
RECRUITING
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Lead Sponsor:
Synaptrix, Inc.
Conditions:
Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07191067
Start Date
September 30 2025
End Date
March 30 2026
Last Update
October 17 2025
Active Locations (1)
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1
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center
Daphne, Alabama, United States, 36526