[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DePuy Synthes Products, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100636546","a-study-of-virtuguide-system-and-depuy-synthes-lapidus-implant-in-participants-undergoing-lapidus-procedure-100636546",false,"NCT07567092","A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure","VIRTUGUIDE™ SYSTEM REGISTRY","Inclusion criteria:\n\n* Participants, both male and female, \\>= 22 years old at the time of consent\n* Participants undergoing a primary Lapidus procedure for the correction of hallux valgus using the VIRTUGUIDE System (software + instruments) and who receive a compatible DePuy Synthes Lapidus implant\n* Participants must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROMs)\n* All primary Lapidus fixation implants are used on-label according to the implant IFU\u002FFDA cleared labeling\n* Participants who can speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and are willing and able to provide informed patient consent for participation and have authorized the transfer of his\u002Fher information to DePuy Synthes\n\nExclusion criteria:\n\n* Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed\n* In the opinion of the Principal Investigator, the subject is unable to comply with the requirements of the registry\n* Participant has known allergies to implant components\n* Participant presenting for a revision of a Lapidus procedure\n* Participant has existing hardware in the operative joint","ALL","22 Years",{"count":19,"type":20},100,"ESTIMATED","12 Months","OBSERVATIONAL","The purpose of this study is to assess the surgeon experience and surgery outcomes in participants undergoing index Lapidus procedure for the correction of hallux valgus (a foot deformity where the big toe angles outward towards the other toes, causing a painful bony bump at the base of the big toe joint) using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implants.",[25],"Hallux Valgus","NOT_YET_RECRUITING","2026-06-04",{"date":29,"type":30},"2026-06-05","ACTUAL",{"date":32,"type":20},"2026-05-15",{"date":34,"type":20},"2028-05-15",{"name":36,"class":37},"DePuy Synthes Products, Inc.","INDUSTRY",8,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":38},"100597482","fibergraft-aeridyan-posterolateral-fusion-study-100597482","NCT07059065","FIBERGRAFT Aeridyan Posterolateral Fusion Study","A Post-market, Prospective, Controlled, Multicenter Clinical Study to Evaluate Radiographic Fusion of FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute in Subjects Who Undergo a Lumbar Posterolateral Fusion Surgery","INCLUSION CRITERIA\n\n1. Subjects who require a 1-3 level instrumented PLF fusion in the lumbar spine in conjunction with a 1 to 2 consecutive level posterior lumbar interbody fusion procedure between L1-S1.\n2. Skeletally mature subjects at least 18 years of age at the time of consenting.\n3. Willing to provide voluntary written informed consent prior to participation in the clinical study.\n\nEXCLUSION CRITERIA\n\n1. Subjects who had previous fusion surgery at the index level(s).\n2. Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and\u002For an interbody fusion at more than two levels\n3. Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.\n4. Pregnant subjects or planning to become pregnant within the next 24 months.\n5. Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.\n6. Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.\n7. Subjects who have an uncontrolled systemic or metabolic disease which, in the Investigator's opinion, would compromise their health, safety, or ability to participate or follow-up in this clinical study.\n8. Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.\n9. Subjects that have infection or osteomyelitis at the graft site. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.\n10. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.\n11. Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.\n12. Subjects unable to comply, and\u002For in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.\n13. Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine\n14. Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).\n15. Body Mass Index (BMI) ≥ 45\n16. Unilateral posterior instrumentation\n17. Subject is currently involved in a workers' compensation claim.\n18. Subject has participated in an interventional clinical trial within the last 6 months or plans to participate in an interventional clinical trial within the next 24 months.","18 Years",{"count":48,"type":20},316,"INTERVENTIONAL",[51],"NA","This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level instrumented lumbar posterolateral fusion surgery. This clinical study will be conducted at up to 10 clinical sites within the United States.",[54],"Degenerative Spine Disease","RECRUITING",{"date":29,"type":30},{"date":58,"type":30},"2025-08-15",{"date":60,"type":20},"2029-05-31",{"name":36,"class":37},""]