RecruitingNot ApplicableNCT07191067

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

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

Sponsor

Synaptrix, Inc.

Enrollment

120 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Pain

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

Min Age: 21 Years

Inclusion Criteria5

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 Criteria16

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.