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

NCT07191067

RecruitingNA

Sponsor: Synaptrix, Inc.

Conditions: Pain

Interventions: Percutaneous radiofrequency electrical nerve stimulation, Non-therapeutic stimulation

Countries: United States

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 overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (5)

Daphne, Alabama, United States
Williamsville, New York, United States
Chapel Hill, North Carolina, United States
Medford, Oregon, United States
Seattle, Washington, United States