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

Not Applicable

Not yet recruiting

• Conditions: Pain

• Registration Number: NCT07191067
• Lead Sponsor: Synaptrix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-09-26
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Worst Pain at Day 10	10 days post-TKA	The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)

Secondary Outcome Measures

Name	Time	Method
Total morphine equivalents used	5 days post-TKA	Total morphine equivalents used cumulatively through Day 5