[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-fracture":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,71],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100617973","us-prospective-evaluation-of-epione-device-for-percutaneous-msk-procedures-100617973",false,"NCT07325578","U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures","Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy","EPIOS","Inclusion Criteria:\n\n* Patients ≥22 years old,\n* Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,\n* Patients who have signed an IRB-approved informed consent form\n* Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure\n* Inclusion criteria linked to the freehand procedure have been discussed and validated\n\nExclusion Criteria:\n\n* Patients with contraindication to undergo general anesthesia,\n* Patients unable to maintain appropriate breathing control,\n* Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated\n* Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,\n* Pregnant or breast-feeding women,\n* Patients subject to a legal protection measure,\n* Patients already participating in another conflicting interventional clinical study,\n* Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.\n* Patients having a coagulation abnormalities or bleeding disorder\n* Patients having an active infection on the day of intervention\n* Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach\n* Exclusion criteria linked to the freehand procedure have been discussed and validated","ALL","22 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.\n\nThe main question is the determination of the rate of feasible procedures assisted by the Epione device\n\nParticipants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:\n\n* The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate\n* Additional CT or CBCT scans during the procedure.",[27,28,29],"Bone Tumor","Osteoporosis","Traumatic Fracture",[31,32,33],"percutaneous procedure","robot assistance","bone procedure","RECRUITING","2026-06-03",{"date":37,"type":38},"2026-06-04","ACTUAL",{"date":40,"type":38},"2026-04-28",{"date":42,"type":21},"2026-10",{"name":44,"class":45},"Precision IO Group","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100455164","device-global-registry-for-the-illuminoss-bone-stabilization-system-100455164","NCT05206981","Device Global Registry for the IlluminOss Bone Stabilization System","IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device","Inclusion Criteria:\n\n1. Patient has been deemed a candidate for the IlluminOss device\n2. Patient is male or non-pregnant female\n3. Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations\n4. Patient is willing and able to give informed consent if required\n5. Traumatic patient is over the age of 50\n6. IlluminOss procedure is the initial procedure to treat the traumatic injury\n\nExclusion Criteria:\n\nUnited States (U.S.)\n\nThis product is contraindicated in U.S. patients who have:\n\n1. an active or incompletely treated infection that could involve the site where the device will be implanted;\n2. are allergic to any of the implant materials or to dental glue;\n3. have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;\n4. distant foci of infections which may spread to the implant site, have open fractures with severe contamination;\n5. or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.\n\nEuropean Union (EU)\n\nThis product is contraindicated in EU patients who have:\n\nFor all Bones:\n\n1. Patients who are considered skeletally immature.\n2. Presence of active or incompletely treated infections that could involve the site where the device will be implanted.\n3. Patients allergic to any of the implant materials, or to dental glue.\n4. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.\n5. Uncooperative patient or patient with neurologic disorder, incapable of following directions.\n6. Distant foci of infections which may spread to the implant site.\n7. Vascular insufficiency.\n8. Open fractures with severe contamination.\n9. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.\n10. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.\n\n    For acute Humerus fractures:\n11. Patients who are under the age of Fifty (50)\n\n    For all bones excluding pathologic Humerus:\n12. Metabolic disorders which may impair bone formation.\n13. Osteomalacia.\n14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.","50 Years",{"count":55,"type":21},300,"1 Year","OBSERVATIONAL","This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.",[29,60],"Pathological Fracture","2026-04-14",{"date":63,"type":38},"2026-04-17",{"date":65,"type":38},"2021-06-11",{"date":67,"type":21},"2026-12",{"name":69,"class":45},"IlluminOss Medical, Inc.",16,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100293225","orthosis-vs-no-orthosis-after-surgically-treated-traumatic-thoracolumbar-fractures-100293225","NCT03097081","ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures","Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures","ORNOT","Inclusion Criteria:\n\n* Age 18 - 65 years\n* Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4\n* AO fracture types A-C\n* Undergoing surgical dorsal fixation for fracture\n\nExclusion Criteria:\n\n* Inadequate knowledge of Dutch language or to fill in questionnaire\n* Complete or partial spinal cord injury (ASIA A to D)\n* (Additional) anterior surgical stabilization\n* Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious\n* Not able to walk before fracturing vertebra\n* Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)\n* Injury Severity Score (ISS) ≥ 16\n* Brain injury with Abbreviated Injury Score (AIS) ≥ 4\n* Solitary Lumbar 5 fracture\n* Inability to wear an orthosis, most probable reasons:\n\n  * BMI \\> 35\n  * Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.\n\n    12 of 27\n  * Pre-existing spine deformities (scoliosis or very severe kyphosis\u002Flordosis) which impair the use of the orthosis or aggravate pain.","18 Years","65 Years",{"count":82,"type":21},45,[24],"Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures.\n\nObjective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis.\n\nStudy design: Randomized controlled intervention study, non-inferiority trial.\n\nStudy population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated by posterior fixation.\n\nIntervention: One group receives standard care and wears an orthosis after surgery for 12 weeks, to use when in vertical position. The intervention group does not wear an orthosis after surgery.\n\nMain study parameters\u002Fendpoints: Main study outcome is the difference in pain noted on the NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change in pain score.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The current guideline for postoperative care regarding dorsal stabilization of spine fractures recommends the use of a post-operative orthosis. While patients generally receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to deviate from this guideline. This is founded by literature that increasingly questions the use of orthoses in the conservative treatment of spine fractures. With the fracture operatively stabilized, the orthosis mainly provides support of gesture and thereby potentially results in pain relief and confidence for patients. On the other hand some patients have a hard time weaning from the orthosis or report discomfort due to the device and prefer not to use it. With subjects being randomized between the use of an orthosis or no orthosis there is no additional risk. This is in part because it is hypothesized that there is no difference in postoperative pain and there might be a lower risk of complications related to the orthosis.",[86,87,29,88],"Spine Fracture","Orthosis","Posterior Fixation","2023-01-21",{"date":91,"type":38},"2023-01-25",{"date":93,"type":4},"2016-11",{"date":95,"type":21},"2026-11",{"name":97,"class":98},"Amsterdam UMC, location VUmc","OTHER",1]