RecruitingNot Applicable

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

United States120 participantsStarted 2025-09-30

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Worst Pain at Day 10

Timeframe: 10 days post-TKA

Trial details

NCT IDNCT07191067

SponsorSynaptrix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Daniel Guerrero

612-227-1483 dan.guerrero@synaptrix.net

View on ClinicalTrials.gov More Pain trials