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

Synaptrix, Inc.

Status: Enrolling

Conditions: Pain

Treatments: Device: Percutaneous radiofrequency electrical nerve stimulation; Device: Non-therapeutic stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07191067

1-25-001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

NOVABLOC Stimulation

Active Comparator group

Description:

Subjects will receive NOVABLOC stimulation prior to their TKA

Treatment:

Device: Percutaneous radiofrequency electrical nerve stimulation

Sham Stimulation

Sham Comparator group

Description:

Subject will receive sham non-therapeutic stimulation

Treatment:

Device: Non-therapeutic stimulation