[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kuros Biosurgery AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100610297","a-prospective-randomized-single-blind-controlled-multi-center-study-to-assess-the-safety-and-performance-of-magnetostm-compared-to-autogenous-bone-graft-in-patients-undergoing-hindfoot-or-ankle-fusions-100610297",false,"NCT07225751","A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.","A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions","ASTRA","Inclusion:\n\n1. Patient is able to read\u002Fbe read, understand, and provide written informed consent and has signed the IRB approved informed consent.\n2. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old\n3. Patients requiring one of the following hindfoot fusion procedures, using surgical technique, necessitating rigid hardware fixation and supplemental bone graft\u002F substitute: ankle fusion (tibiotalar) subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints).\n4. Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.\n\nExclusion:\n\n1. Expected to need secondary intervention within one year following surgery.\n2. Had prior fusion or attempted fusion of the joints to be fused.\n3. Patient is not ambulatory.\n4. Surgical technique where bone graft is not expected to be used.\n5. Conditions at the surgeon's discretion in which general bone grafting is not advisable.\n6. Radiographic evidence of fractures or pathologies around the fusion that could negatively impact the fusion process (e.g., growth plate fracture around the fusion or bone cysts).\n7. Significant vascular impairment proximal to the graft site.\n8. Acute and\u002For chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis)\n9. Pre-existing sensory impairment (e.g. diabetes, Charcot). Diabetics patients with HbA1c greater than 7.0 OR that were not sensitive to the 5.07 monofilament will be excluded.\n10. Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia).\n11. If intraoperative soft tissue coverage is not planned or possible.\n12. Receiving treatment with medication interfering with calcium metabolism (chronic use of glucocorticoid and use high dose NSAIDs 800 mg TID for \\> the first 6 weeks post-op).\n13. Has benign or malignant tumor at the surgical site.\n14. Has history or presence of active malignancy (non-invasive skin cancer is allowed).\n15. Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements (e.g. prisoners, physically or mentally compromised, etc.).\n16. Is involved in active litigation relating to his\u002Fher foot and ankle condition.\n17. Participation in an investigational study within 30 days prior to surgery for study devices.\n18. Patient with body mass index (BMI) \\> 50.\n19. Patient cannot comply with all post-operative evaluation and visits .\n20. Any pre-existing condition that the surgeon determines could interfere with the patient's ability to perform objective functional measurements.\n21. Women who are or intend to become pregnant within the next 12 months.","ALL","18 Years","75 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders.\n\nIn this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.",[28,29,30,31,32,33],"Ankle Arthrodesis or Arthroplasty","Hindfoot Fusion","Ankle Deformity","Ankle Disease","Hindfoot Arthrodesis","Hindfoot Pathologies",[35,36],"ankle arthrodesis","hindfoot fusion","RECRUITING","2026-04-08",{"date":40,"type":41},"2026-04-09","ACTUAL",{"date":43,"type":41},"2025-11-25",{"date":45,"type":22},"2028-12",{"name":47,"class":48},"Kuros Biosurgery AG","INDUSTRY",5,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100414686","post-marketing-study-of-magnetos-easypack-putty-standalone-compared-to-demineralized-bone-matrix-or-fibers-mixed-with-autograft-in-patients-undergoing-posterolateral-lumbar-fusion-100414686","NCT04679844","Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion","A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar\u002FThoracolumbar Fusion (PLF)","PROOF","Inclusion Criteria:\n\n* Patient is able to read\u002Fbe read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.\n* Male or female patient ≥ 18 years old.\n* Patients with segmental mechanical spinal instability requiring arthrodesis surgery.\n\nInstability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar\u002Fthoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:\n\n1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion\u002Fextension radiographs),\n2. decreased disc height by \\> 2 mm, but dependent upon the spinal level\n3. Grade II or more listhesis\n4. TLICS equal or greater than 5\n5. Unstable burst fracture\n\n   * Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.\n\nExclusion Criteria:\n\n* Requires \\> two-level fusion or expected to need secondary intervention within one year following surgery.\n* Had prior PLF fusion or attempted PLF fusion at the involved levels.\n* Had previous decompression at the involved levels.\n* Women who are or intend to become pregnant within the next 12 months.\n* To treat conditions in which general bone grafting is not advisable.\n* In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).\n* In case of significant vascular impairment proximal to the graft site.\n* In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage \\>4 renal disease or Paget's Disease) that affect bone or wound healing.\n* In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).\n* When intraoperative soft tissue coverage is not planned or possible.\n* Receiving treatment with medication interfering with calcium metabolism.\n* Has degenerative disc disease (DDD) related to a benign or malignant tumor.\n* Has history or presence of active malignancy.\n* Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.\n* Is involved in active litigation relating to his\u002Fher spinal condition.\n* Has participated in an investigational study within 30 days prior to surgery for study devices.",{"count":59,"type":22},60,[25],"This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.\n\nIn this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.",[63,64,65],"Degenerative Disc Disease","Spine Fusion","Back Pain",[63,64],"2026-03-18",{"date":69,"type":41},"2026-03-20",{"date":71,"type":41},"2024-12-06",{"date":73,"type":22},"2027-08-30",{"name":47,"class":48},6,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100442175","magnetos-flex-matrix-compared-to-trinity-elite-mixed-with-local-autograft-in-patients-undergoing-up-to-four-level-instrumented-posterolateral-fusion-100442175","NCT05037968","MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion","A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar\u002FThoraco-lumbar Fusion (PLF)","PRECISE","Inclusion Criteria:\n\n* Patient is able to read\u002Fbe read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.\n* Male or female patient ≥ 18 years old.\n* Patients with leg pain, and\u002For back pain requiring up to four-level instrumented posterolateral lumbar\u002Fthoraco-lumbar fusion (T11 - S1)\n* Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.\n\nExclusion Criteria:\n\n* Requires \\> four-level fusion or expected to need secondary intervention within one year following surgery.\n* Had prior PLF fusion or attempted PLF fusion at the involved levels\n* Had previous decompression at the involved levels.\n* Women who are or intend to become pregnant within the next 12 months\n* To treat conditions in which general bone grafting is not advisable.\n* In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).\n* In case of significant vascular impairment proximal to the graft site.\n* In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.\n* In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).\n* When intraoperative soft tissue coverage is not planned or possible.\n* Receiving treatment with medication interfering with calcium metabolism.\n* Had leg pain, and\u002For back pain related to a benign or malignant tumor.\n* Had history or presence of active malignancy.\n* Has known substance abuse, psychiatric disorder, or condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.\n* Is involved in active litigation relating to his\u002Fher spinal condition.\n* Has participated in an investigational study within 30 days prior to surgery for study devices.",{"count":85,"type":22},100,[25],"This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.\n\nIn this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.\n\nTrinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.",[63,64,89],"Leg Pain and\u002For Back Pain",[63,64],"2026-02-23",{"date":93,"type":41},"2026-02-25",{"date":95,"type":41},"2024-06-10",{"date":97,"type":22},"2026-12",{"name":47,"class":48},7,""]