RecruitingPain
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Eligible age
21+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Synaptrix, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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;
Where it's recruiting
Source: ClinicalTrials.gov · NCT07191067 · last updated 2026-08-21