[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Synaptrix, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100607631","pivotal-study-on-the-novabloc-system-for-patients-undergoing-primary-total-knee-arthroplasty-100607631",false,"NCT07191067","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","NOVABLOC-TKA","Inclusion Criteria:\n\n1. Male or non-pregnant females age ≥ 21 years of age;\n2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;\n3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);\n4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.\n5. Able to read and understand instructions and information presented in English.\n\nExclusion Criteria:\n\n1. Chronic opioid use (average ≥ 30 oral morphine equivalents \u002F day) ≤ thirty (30) days of the TKA procedure;\n2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;\n3. History of substance abuse or misuse;\n4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);\n5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee;\n6. Prior TKA on the operative knee;\n7. BMI \\> 40;\n8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;\n9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \\[ear\\] stimulator);\n10. History of hip or knee dislocation or bone fractures on the operative leg;\n11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;\n12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \\>10) or depression (PHQ-9 score \\>15);\n13. Pregnant, actively planning a pregnancy or breast-feeding a child;\n14. Uncontrolled diabetes (A1C \\> 7.5%);\n15. History of bleeding disorder;\n16. Participating in another clinical trial\u002Finvestigation within 45 days prior to signing informed consent.","ALL","21 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Pain","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2025-09-30",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Synaptrix, Inc.","INDUSTRY",5,""]