NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
| NCT ID | NCT07191067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Synaptrix, Inc. |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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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 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 radi