[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AO Innovation Translation Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":305},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,49,78,106,135,159,182,208,229,254,277],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100269748","primary-tumor-research-and-outcomes-network-100269748",false,"NCT02790983","Primary Tumor Research and Outcomes Network","Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine","PTRON","Inclusion criteria\n\n* Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and\u002For spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.).\n* Informed consent obtained, i.e.:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the registry according to the Registry Plan (RP)\n  * Signed and dated EC\u002FIRB approved written informed consent\n\nOR\n\n* Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide independent written informed consent\n\nExclusion Criteria:\n\n\\- Patient diagnosed with a metastatic tumor of the spine.","ALL",{"count":19,"type":20},1350,"ESTIMATED","3 Years","OBSERVATIONAL","This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.",[25],"Spinal Column Tumor",[27,28,29,30,31,32,33,34,35],"Registry","Spine","Surgery","Medical Oncology","Radiation Oncology","Neoplasms","Systemic Oncologic Therapy","Radiation Therapy","Tumor Markers","RECRUITING","2026-02-24",{"date":39,"type":40},"2026-02-25","ACTUAL",{"date":42,"type":4},"2016-10",{"date":44,"type":20},"2028-12",{"name":46,"class":47},"AO Innovation Translation Center","OTHER",19,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":22,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100361866","alloplastic-total-temporomandibular-joint-tmj-replacement-registry-100361866","NCT03991728","Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry","International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements","Inclusion Criteria:\n\n* Age 18 years and or older\n* Patients requiring alloplastic total TMJ replacement\n* Informed consent obtained, i.e.:\n\n  * Ability to understand the content of the patient information\u002Finformed consent form (ICF)\n  * Willingness and ability to participate in the registry according to the Registry Plan (RP)\n  * Signed and dated ethics committee (EC) \u002F Institutional review board (IRB) approved written informed consent\n\nExclusion Criteria:\n\n* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment\n* Pregnancy or women planning to conceive within the study period\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study","18 Years",{"count":58,"type":20},200,"5 Years","Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).\n\nThis registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.",[62],"Temporomandibular Joint Disorders",[64,65,66,67,68,27],"Temporomandibular joint","TMJ replacement","Trauma","Ankylosis","Degenerative joint disease","2026-02-17",{"date":71,"type":40},"2026-02-18",{"date":73,"type":40},"2019-10-15",{"date":75,"type":20},"2033-12",{"name":46,"class":47},23,{"id":79,"slug":4,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":87,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100376534","NCT04182776","Fragility Fractures of the Pelvis (FFP)","Fragility Fractures of the Pelvis: Observational Outcome Study","Inclusion Criteria:\n\n* Age 65 years or older at time of injury\n* Diagnosis, via CT scan as per standard of care, of FFP grade II or higher according to the Rommens and Hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures)\n* Informed consent obtained, ie:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the registry according to the standard of care in each clinic\n  * Signed and dated Ethics Committee (EC)\u002F Institutional Review Board (IRB) approved written informed consent OR\n  * Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide independent written informed consent\n\nExclusion Criteria:\n\n* Pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma)\n* FFP type I fractures\n* Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above)\n* Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections)\n* Concomitant osteoporotic fractures outside of pelvis\n* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present registry","65 Years",{"count":86,"type":20},420,"1 Year","Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann.\n\nPatients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).",[90],"Pelvic Fracture",[92,93,94,95,96],"Pelvis","Fragility Fracture","Classification","Conservative","Operative","2025-12-15",{"date":99,"type":40},"2025-12-19",{"date":101,"type":40},"2022-03-01",{"date":103,"type":20},"2026-06",{"name":46,"class":47},10,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100608247","rate-of-bone-union-after-surgery-with-stand-alone-fibergraft-100608247","NCT07199075","Rate of Bone Union After Surgery With Stand-alone Fibergraft","Fusion Rate of Anterior Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Using Titanium Cages Filled With Stand-alone Fibergraft in Lumbar Spinal Fusion","Fibergraft","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity.\n* Undergone primary surgery of ALIF or XLIF using titanium cages filled with standalone Fibergraft and with the following criteria fulfilled (ie, the index surgery):\n\n  * ALIF (up to 2 levels) as either standalone (ie, no posterior procedure) or as an anterior first procedure with posterior procedure as a second procedure.\n  * XLIF (up to 2 levels) as an anterior first procedure with posterior procedure as a second procedure.\n* Consenting to have CT scans taken to allow assessment of fusion status at 12-24 months post index surgery\n\n  * This criterion is applicable to patients who have not undergone revision surgery.\n  * For patients who have undergone revision surgery due to any reason other than nonunion, which typically occurs within 1 year of the index surgery, this criterion is only applicable if it is possible to obtain the CT scan within 12-24 months of the index surgery. If no CT scan can be taken during this window, the patient does not need to undergo the CT scan; in such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will be retrospectively retrieved to assess the fusion status at the time of the revision surgery.\n  * This criterion is not applicable to patients who underwent revision surgery due to nonunion, which typically occurs 1 year after the index surgery; these patients do not need to undergo the CT scan. In such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will also be retrospectively retrieved to assess and grade the fusion status at the time of the revision surgery.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Revision surgery\n* Standalone XLIF\n* Posterior lumbar interbody fusion\n* Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome\n* Diagnosis of Parkinson's disease\n* Body mass index \\> 35kg\u002Fm2",{"count":115,"type":20},80,"Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine.\n\nAt the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body.\n\nThis study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure",[118,119,120,121,122,123,124],"Spine Degeneration","Spine Disorder","Spine Pain","Spine Fusion","Spine Fusion for Degenerative Spine Disease","Nerve Root Compress;Lumbosac","Spondylolisthesis","NOT_YET_RECRUITING","2025-09-22",{"date":128,"type":40},"2025-09-30",{"date":130,"type":20},"2025-10-31",{"date":132,"type":20},"2026-05-30",{"name":46,"class":47},1,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":143,"targetDuration":145,"studyType":22,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100314825","periprosthetic-fracture-registry-ppfx-100314825","NCT03378557","Periprosthetic Fracture Registry (PPFx)","Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty","PPFx","Inclusion Criteria:\n\n* Age ≥18 years\n\n  * Post-operative PPFx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring\n\n    * osteosynthesis alone or\n    * component revision plus plate\u002Fnail osteosynthesis\n  * Informed consent obtained, i.e.:\n\n    * Ability of the patient or assigned representative to understand the content of the patient information \u002F Informed Consent Form\n    * Signed and dated EC \u002F IRB approved written informed consent\n  * Ability to attend post-operative follow up visits\n\nExclusion Criteria:\n\n* Pregnancy or women planning to conceive within the study period\n* Prisoner",{"count":144,"type":20},600,"12 Months","This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty.\n\nA registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.",[148,149],"Periprosthetic Fractures","Periprosthetic Fracture Around Prosthetic Joint Implant","2025-09-08",{"date":152,"type":40},"2025-09-12",{"date":154,"type":40},"2018-12-31",{"date":156,"type":20},"2027-03-31",{"name":46,"class":47},13,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100433264","case-series-on-the-clinical-performance-of-va-clavicle-and-clavicle-hook-plate-27-systems-100433264","NCT04921865","Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems","Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use:\n\n  * VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments\n  * VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint\n  * VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations\n* Expected ability to attend postoperative FU visits\n* Patient informed and consent obtained according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Stable clavicle fractures\n* Systemic infection or infection localized to the site of the proposed implantation\n* Concomitant nerve or vessel injury\n* Polytrauma (Injury Severity Score ≥ 16)\n* BMI ≥40\n* Uncontrolled severe systemic disease or terminal illness\n* Intraoperative decision to use other implant",{"count":167,"type":20},76,"The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System.\n\nA minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation.\n\nOutcomes will be collected until up to 2 years after surgery.",[170,171,172],"Clavicle","Acromioclavicular Joint","Fracture","2025-08-28",{"date":175,"type":40},"2025-08-29",{"date":177,"type":40},"2024-07-10",{"date":179,"type":20},"2029-09-30",{"name":46,"class":47},7,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":189,"targetDuration":191,"studyType":22,"phases":4,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":48},"100370038","registry-to-collect-data-on-patients-undergoing-segmental-mandibular-defect-reconstruction-following-oral-squamous-cell-carcinoma-resection-and-drugs-induced-osteonecrosis-100370038","NCT04098146","Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis","A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis","Inclusion Criteria:\n\n* The study includes patients with an initial pathological\u002Fhistologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.\n* Age 18 years and older\n* Bisphosphonate related osteonecrosis of the mandible\n* Immunomodulatory drugs induced mandibular osteonecrosis\n* Patients presented with ameloblastoma affecting the mandible\n* Patients presented with osteosarcomas of the mandible\n* Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney\n* Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm\n* Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach\n* Informed consent obtained, ie:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB\u002FEC approved ICF OR\n  * Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide to provide independent written informed consent\n\nExclusion Criteria:\n\n* Tumors affecting the condyle\n* Patients under palliative care\n* Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures\n\nIntraoperative exclusion criteria:\n\n* Nonsegmental mandibular defect (eg. box resection\u002Fpartial resection)\n* Segmental mandibular defect of less than 2 cm\n* Mandibular defects extending beyond the sigmoid notch into the condyles\n\nAdditional exclusion criterion:\n\n• No osseous reconstruction with autologous bone performed within 18 months from resection",{"count":190,"type":20},300,"2 Years","Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.",[194,195],"Mandibular Reconstruction","Segmental Mandibular Defects",[197,198,199,200],"Mandibular osteotomy","Free bone flap","Reconstructive surgical procedure","Adjuvant Irradiation \u002F Chemotherapy",{"date":202,"type":40},"2025-09-04",{"date":204,"type":40},"2022-09-12",{"date":206,"type":20},"2030-12-31",{"name":46,"class":47},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":215,"targetDuration":87,"studyType":22,"phases":4,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100371178","an-international-multicenter-prospective-registry-on-post-traumatic-long-bones-defects-100371178","NCT04112992","An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects","An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Skeletally mature\n* Post traumatic bone defect \\> 2 cm either\n\n  * initially after injury or\n  * after surgical debridement\n* Informed consent obtained, i.e.:\n\n  * Ability to understand the content of the patient information\u002FICF\n  * Willingness and ability to participate in the clinical investigation according to the registry plan\n  * Signed and dated EC\u002FIRB approved written informed consent OR\n  * Written consent provided according to the IRB\u002FEC defined and approved procedures for patients who are not able to provide independent written informed consent\n\nExclusion Criteria:\n\n* Any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices\n* Any not medically managed severe systemic disease\n* Pregnancy\n* Prisoners\n* Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry",{"count":144,"type":20},"Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group.\n\nReports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations.\n\nIn a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.",[218,219],"Limb Fracture","Bone Loss",[221],"long bone defect",{"date":175,"type":40},{"date":224,"type":40},"2024-07-03",{"date":226,"type":20},"2029-03-30",{"name":46,"class":47},21,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":236,"targetDuration":237,"studyType":22,"phases":4,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100581052","ao-csh-mainstream-study-on-cervical-spine-degeneration-100581052","NCT06845293","AO CSH Mainstream Study on Cervical Spine Degeneration","CASDEM","Inclusion Criteria:\n\n* Age 18 years and older\n* Undergoing primary surgical treatment for cervical degenerative disease\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Age under 18 years\n* Patients with spinal infection\n* Patients with spinal tumor\n* Patients with acute spinal injuries\u002Ftrauma within 1 year",{"count":190,"type":20},"1 Day","Adult patients with cervical degenerative diseases undergoing primary anterior and\u002For posterior cervical fusion will be prospectively enrolled from participating sites.\n\nPatients will be treated and followed up at the participating sites per local standard of care. Several variables related to the patient characteristics and fusion details will be collected. The mainstream study will not collect follow-up (FU) data.\n\nThe duration of this patient cohort is currently planned as open ended.",[240],"Cervical Spine Degenerative Disease",[240,242,243,244,245],"prospective multicenter patient cohort","anterior fusion","posterior fusion","Clinical Study Hub","2025-02-24",{"date":248,"type":40},"2025-02-25",{"date":250,"type":20},"2025-07-01",{"date":252,"type":20},"2035-07-31",{"name":46,"class":47},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":4},"100558424","surgical-treatment-of-pelvis-in-fragility-fracture-in-germany-a-prospective-national-multicenter-observational-comparative-cohort-study-comparing-isolated-posterior-versus-combined-anterior-posterior-surgical-fracture-stabilization-100558424","NCT06550934","Surgical Treatment of Pelvis in Fragility Fracture in Germany: a Prospective, National, Multicenter, Observational, Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization","AO TOP","Inclusion Criteria:\n\n* Patients with sacral FFP (no concomitant injuries) Types: IIc, IIIc, IVb, IVc according to Rommens and Hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included)\n* Diagnostic workup for fracture diagnosis and classification performed using CT scan as per standard of care\n* Indication for surgical fracture fixation as considered by the attending surgeon\n* Age ≥ 65 yrs.\n* Low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture\n* ASA-Score ≤ 3 pts.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Patients with multiple fractures\n* Instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and\u002For fractures of the pubic rami next to the symphysis, that indicate instability\n* Pelvic fractures due to high-energy trauma\n* Pathologic fractures (eg, fractures caused by malignancy or infection)\n* History of pelvic fracture or pelvic ring surgery (hip joint implants do not count)\n* Clinically significant or unstable medical or surgical condition that prevents surgical treatment",{"count":86,"type":20},"Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.\n\nPain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.",[264],"Pelvis; Fracture",[92,266,94,267,96,268],"Fragility fracture","Management","Outcome","2025-02-13",{"date":271,"type":40},"2025-02-14",{"date":273,"type":20},"2025-03",{"date":275,"type":20},"2027-10",{"name":46,"class":47},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100470801","fracture-monitor---femur-100470801","NCT05410587","Fracture Monitor - Femur","Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients with Femur Fractures Treated with a Locking Compression Plate","Inclusion Criteria:\n\n* Age 18 years or older\n* Closed growth plates at time of injury\n* Femoral fracture requiring osteosynthesis and treated with one of the following plates:\n\n  * DePuy Synthes LCP® 4.5\u002F5, Broad\n  * DePuy Synthes LCP® 4.5\u002F5, Broad Curved\n  * DePuy Synthes LCP® Condylar Plate 4.5\u002F5.0\n  * DePuy Synthes VA-LCP® Condylar Plate 4.5\u002F5.0\n  * DePuy Synthes LCP® Distal Femur\n  * DePuy Synthes LCP® Proximal Femoral Plate 4.5\u002F5.0\n  * DePuy Synthes LCP® Proximal Femur Hook Plate\n  * 41medical AG, Biphasic Plate DF\n* ASA score 1-3\n* Full weight-bearing capacity prior to the injury\n* The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg\n* Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care\n* Ability to provide written informed consent\n\nPreoperative exclusion Criteria:\n\n* Concomitant fractures in the contralateral leg\n* Electromagnetic hypersensitivity\n* Implanted electromagnetic bone stimulators\n* Pregnancy (determined by pregnancy test)\n* Prisoner\n* Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation\n\nIntraoperative exclusion criteria:\n\n* Use of compression lag screw across fracture fragment\n* Compression osteosynthesis\n* Precontouring of implant at the area of the attachment of Fracture Monitor T1\n* Double-plating technique\n* Soft-tissue coverage \\> 6 cm above the data logger\n* Concurrent use of intramedullary nail\n* Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1\n* Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available",{"count":285,"type":20},37,"INTERVENTIONAL",[288],"NA","Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care.\n\nThe primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability.\n\nAll adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device.\n\nAll patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months.\n\nThe results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.",[291],"Femoral Fracture",[293,294,295],"Fracture fixation, internal","Femur","Fracture healing","2025-01-30",{"date":298,"type":40},"2025-02-03",{"date":300,"type":40},"2023-10-03",{"date":302,"type":20},"2026-07",{"name":46,"class":47},4,""]