[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607631":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":122,"collaborators":26,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":26,"enrollmentInfo":134,"targetDuration":26,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Synaptrix, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NOVABLOC Stimulation","ACTIVE_COMPARATOR","Subjects will receive NOVABLOC stimulation prior to their TKA",[13],"Device: Percutaneous radiofrequency electrical nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Stimulation","SHAM_COMPARATOR","Subject will receive sham non-therapeutic stimulation",[19],"Device: Non-therapeutic stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Percutaneous radiofrequency electrical nerve stimulation","Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-therapeutic stimulation","Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Daniel Guerrero","CONTACT","612-227-1483","dan.guerrero@synaptrix.net",[38,60,76,92,106],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center","RECRUITING","Daphne","Alabama","36526","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-87.9036,30.60353,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Natalia Alexeeva, PhD","315-395-3300","natalex7230@outlook.com",{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Daniel Matthews, MD","PRINCIPAL_INVESTIGATOR",{"facility":61,"status":40,"city":62,"state":63,"zip":64,"country":44,"countryCode":45,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"UBMD Orthopedics and Sports Medicine","Williamsville","New York","14221",{"type":47,"coordinates":66},[67,68],-78.73781,42.96395,{"lat":68,"lon":67},[71,74],{"name":72,"role":34,"phone":73,"phoneExt":26,"email":26},"Sonja Pavlesen, MD","716-906-5954",{"name":75,"role":59,"phone":26,"phoneExt":26,"email":26},"Shridar Rachala, MD",{"facility":77,"status":40,"city":78,"state":79,"zip":80,"country":44,"countryCode":45,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of North Carolina","Chapel Hill","North Carolina","27517",{"type":47,"coordinates":82},[83,84],-79.05584,35.9132,{"lat":84,"lon":83},[87,90],{"name":88,"role":34,"phone":26,"phoneExt":26,"email":89},"Karen Van Manen","karen_vanmanen@med.unc.edu",{"name":91,"role":59,"phone":26,"phoneExt":26,"email":26},"Stuart Grant, MD",{"facility":93,"status":40,"city":94,"state":95,"zip":96,"country":44,"countryCode":45,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Southern Oregon Orthopedics","Medford","Oregon","97504",{"type":47,"coordinates":98},[99,100],-122.87559,42.32652,{"lat":100,"lon":99},[103,104],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},{"name":105,"role":59,"phone":26,"phoneExt":26,"email":26},"Jeffrey Jancuska, MD",{"facility":107,"status":40,"city":108,"state":109,"zip":110,"country":44,"countryCode":45,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Virginia Mason Medical Center","Seattle","Washington","98101",{"type":47,"coordinates":112},[113,114],-122.33207,47.60621,{"lat":114,"lon":113},[117,120],{"name":118,"role":34,"phone":26,"phoneExt":26,"email":119},"Leslie Stevens","leslie.stevens@commonspirit.org",{"name":121,"role":59,"phone":26,"phoneExt":26,"email":26},"David Auyong, MD",{"type":123,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":135,"type":136},120,"ESTIMATED","INTERVENTIONAL",[139],"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.",[142],"Pain","2026-08-20",{"date":145,"type":146},"2026-08-21","ACTUAL",{"date":148,"type":146},"2025-09-30",{"date":150,"type":136},"2026-12-31",{"name":5,"class":6},5]