[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto Ortopedico Rizzoli\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":592},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,97,0,25,[9,46,68,91,115,140,168,197,218,245,266,289,314,335,356,378,399,418,441,459,480,503,529,552,569],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100625440","arthroscopic-treatment-of-acetabular-labral-lesions-intrarticular-injection-of-bone-marrow-vs-hip-arthroscopy-alone-100625440",false,"NCT07422662","Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone","Single-blind Randomized Study on the Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone","Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 55;\n2. Pelvic and hip X-ray showing no severe osteoarthritis (defined as advanced osteoarthritis with large osteophytes, chronic fractures or bone remodeling, severe deformity or bone friction, and\u002For bone-to-bone contact indicative of severe osteoarthritis\u002Fcomplete loss of cartilage);\n3. MRI of the pelvis showing suspected acetabular labral tear;\n4. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical follow-up;\n5. Signature of informed consent.\n\nExclusion Criteria:\n\n1. Patients incapable of understanding and willing;\n2. Diagnosis of leukemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;\n3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;\n4. Patients with uncontrolled diabetes mellitus;\n5. Patients with uncontrolled thyroid metabolic disorders;\n6. Patients who abuse alcohol, drugs, or medications;\n7. Body Mass Index \\> 40;\n8. Pregnancy or breastfeeding, or intention to become pregnant during the study period.\n9. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.\n10. Patients who have undergone hip surgery in the previous 12 months.","ALL","18 Years","55 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The BoneMarrowHip study is a single-blind, randomized, single-center trial. Through this study, the clinical results of patients treated during hip arthroscopy surgery with autologous bone marrow infiltration taken from the ipsilateral iliac crest will be evaluated and compared, comparing the outcomes with a group of patients undergoing the same surgical treatment but without intra-articular infiltration. All selected patients have acetabular labral tears diagnosed by MRI imaging. In addition, the study will evaluate the safety of the treatment by documenting any adverse events.",[28],"FemoroAcetabular Impingement",[30,31,32],"BMAC injection","hip arthroscopy","Acetabular labral tears","NOT_YET_RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":22},"2026-09",{"date":41,"type":22},"2032-04",{"name":43,"class":44},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100553798","analysis-of-the-pathophysiological-and-functional-state-of-the-knee-joint-100553798","NCT06490770","Analysis of the Pathophysiological and Functional State of the Knee Joint","Gait-MRI-Knee","Inclusion Criteria:\n\n* Knee pain and\u002For loss of functionality\n* Kellgren-Lawrence grade less than or equal to 2\n* Arthroscopic evidence of cartilage tissue lesions\n* Evidence of cartilage and\u002For meniscal tissue degeneration and\u002For subchondral bone marrow lesions\n\nExclusion Criteria:\n\n* History\u002Fevidence of previous partial or total knee prosthesis interventions\n* Inability to provide informed consent\n* Conditions or physical disorders incompatible with the use of MRI and electrical stimulation (implanted active and passive biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)","60 Years",{"count":7,"type":22},[25],"Osteoarthritis is the most common degenerative condition affecting the knee joint globally, with an incidence of about 7% of the population. In Italy, it affects approximately 3.9 million people, with a direct treatment cost of around €2.5 billion. At the joint level, osteoarthritis manifests with pain and reduced functionality, worsening as the disease progresses and severely limiting knee movement. Compounding this, osteoarthritis can impact both elderly and younger individuals due to traumatic factors.\n\nDespite its significant impact, effective treatments for osteoarthritis that address its underlying causes are still lacking, focusing mainly on symptom management. Therefore, improving diagnostic and prognostic approaches is crucial to better understand its onset and progression.\n\nMRI is a primary diagnostic tool for assessing the knee joint's pathophysiological state. It uses tissue-specific sequences to investigate joint homeostasis in detail, although it primarily provides insights into morphology, structure, and tissue composition rather than functional changes within the joint. This limitation is noteworthy because joint homeostasis involves complex interactions among biomechanical, structural, and biological processes, which are directly influenced by osteoarthritis.\n\nGait analysis provides valuable diagnostic information on joint function. By integrating sensor measurements and electronic systems with patient-specific musculoskeletal models derived from MRI morphometric data, it is possible to assess the forces and moments within the joint during specific movements.\n\nGiven that osteoarthritis affects the entire joint, employing multidisciplinary approaches can enhance diagnostic precision and provide insights into the progressive impact of degenerative conditions like osteoarthritis on joint health.",[58,59],"Osteoarthritis, Knee","Cartilage Degeneration","RECRUITING",{"date":62,"type":37},"2026-07-02",{"date":64,"type":37},"2025-07-09",{"date":66,"type":22},"2027-04",{"name":43,"class":44},{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":75,"maxAge":53,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100534447","long-term-outcome-evaluation-of-patients-undergoing-autologous-chondrocyte-transplantation-delivered-on-biomaterial-100534447","NCT06238947","Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial","LONG-TERM EVALUATION OF OUTCOMES OF PATIENTS UNDERGOING AUTOLOGOUS CHONDROCYTE TRANSPLANTATION DELIVERED ON BIOMATERIAL (HYALOGRAFT C) Prospective Observational Study","Inclusion Criteria:\n\n* Patients who underwent autologous chondrocyte transplantation surgery delivered on biomaterial (Hyalograft C) from 1999 to 2006 at the Rizzoli Orthopaedic Institute who met the following criteria at the time of surgery:\n* Full-thickness chondral defects (Outerbridge grade III - IV) and osteochondral defects at the femoral condyles, trochlea, patella and tibial plateau.\n* Patients aged between 14 and 60 years at the time of surgery.\n* Male and female sex.\n\nExclusion Criteria:\n\n* Patients no longer available","14 Years",{"count":77,"type":22},200,"OBSERVATIONAL","Chondro-Long study is prospective observational study for a long-term clinical evaluation (follow-up up to 25 years) in patients treated with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) at the level of femoral condyles, trochlea, patella and tibial plateau.\n\nThe aim of the study is to collect long-term clinical data from the case series of patients surgically treated from 1999 to 2006 with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) or osteochondral defects at the level of femoral condyles, trochlea, patella, and tibial plateau. The objective of the study is to demonstrate the efficacy of this long-term cartilage regeneration technique (follow-up up to 25 years) in improving patient symptomatology and functional capacity",[81,82],"Cartilage Injury","Cartilage Disease",[84,85],"autologous chondrocyte transplantation","osteochondral defects",{"date":36,"type":37},{"date":39,"type":22},{"date":89,"type":22},"2027-02",{"name":43,"class":44},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":45},"100634790","evaluation-of-5-year-survival-and-clinical-outcomes-in-patients-undergoing-total-knee-arthroplasty-with-a-polyethylene-tibial-component-100634790","NCT07544264","Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component","ALLPOLY-TKA","Inclusion Criteria:\n\n1. Male and female subjects aged ≥50 and ≤85 years who are candidates for primary cemented total knee arthroplasty based on physical examination and medical history, including a diagnosis of severe knee pain and disability due to at least one of the following conditions:\n\n   1. Primary or secondary osteoarthritis\n   2. Collagen disorders and\u002For avascular necrosis of the femoral condyle\n   3. Moderate valgus, varus, or flexion deformities (Hip-Knee-Ankle angle within ±15°).\n2. Patients who provide consent and are able to complete the scheduled study procedures and follow-up assessments.\n3. Patients who sign the informed consent approved by the Ethics Committee.\n\nExclusion Criteria:\n\n1. Patients under 50 years of age and over 85 years of age;\n2. Diagnosis of rheumatoid arthritis;\n3. Patients with a contralateral joint prosthesis on the same side;\n4. Coronal plane deformity with a Hip-Knee-Ankle (HKA) angle greater than 15 degrees in varus or valgus.","50 Years","85 Years",{"count":101,"type":22},78,[25],"Total knee arthroplasty (TKA) is one of the most successful procedures in orthopedic surgery for treating advanced knee osteoarthritis, providing pain relief, functional recovery, and improved quality of life. Advances in implant design and materials have further enhanced joint kinematics and patient satisfaction.\n\nAn aging population has increased the number of elderly patients with comorbidities, potentially affecting surgical outcomes and implant longevity. Polyethylene has long been used in knee prostheses; early all-polyethylene tibial components were abandoned due to high wear and failure rates, in favor of metal-backed designs, which became the gold standard.\n\nRecently, highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE) has renewed interest in all-polyethylene tibial components, although their use remains limited. These implants offer potential advantages, including elimination of locking mechanism failures, reduced backside wear, lower costs, and possibly better load distribution.\n\nEvidence from registries, systematic reviews, and meta-analyses shows that 15-year survival of all-polyethylene tibial components is comparable or even superior to metal-backed designs, with no significant differences in clinical-functional outcomes. Additionally, all-poly components are significantly less expensive.\n\nGiven these findings, increasing their use and evaluating outcomes in Italy is warranted. The aim of the present study is to assess implant survival of the Link Symphoknee prosthesis with an all-polyethylene tibial component, along with clinical-functional outcomes and post-discharge readmission rates in patients treated at the Rizzoli Orthopaedic Institute.",[105,106],"Prosthesis Survival","Arthropathy of Knee","2026-06-22",{"date":109,"type":37},"2026-06-23",{"date":111,"type":37},"2026-05-13",{"date":113,"type":22},"2032-10",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100618587","development-and-pre-validation-of-a-machine-learning-based-prediction-algorithm-for-early-functional-recovery-in-patients-undergoing-hip-and-knee-replacement-surgery-100618587","NCT07333560","Development and Pre-validation of a Machine Learning-based Prediction Algorithm for Early Functional Recovery in Patients Undergoing Hip and Knee Replacement Surgery","Development and Pre-validated Multiple Variable Prediction Model Using Machine Learning for Early Functional Recovery After Joint Replacement Surgery.","FISIO_IA","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients underwent elective hip or knee arthroplasty.\n* Patients for whom postoperative physiotherapy was initiated.\n\nExclusion Criteria:\n\n* Patients who underwent surgery for oncologic disease, femoral fracture, or revision joint arthroplasty.\n* Patients for whom postoperative physiotherapy was not provided due to postoperative complications\n* clinical data are unavailable.",{"count":124,"type":22},943,"The goal of this observational study is to develop and pre-validate a machine learning algorithm to predict early recovery of mobility in patients undergoing hip or knee joint replacement surgery. The primary research question is:\n\nCan a machine learning model accurately classify patients with faster versus slower recovery of autonomous mobility in the first days after joint replacement surgery?\n\nPatients who have undergone elective hip or knee arthroplasty and received post-operative physiotherapy will have their clinical and perioperative data collected retrospectively (2020-2023) and prospectively (March 2026-December 2027). The algorithm will be trained on retrospective data and tested prospectively to evaluate its predictive performance for early mobilization and length of hospital stay.",[127,128,129,130],"Artificial Intelligence (AI)","Machine Learning","Joint Replacement","Predictive Model","2026-05-27",{"date":133,"type":37},"2026-06-01",{"date":135,"type":37},"2026-03-09",{"date":137,"type":22},"2027-12",{"name":43,"class":44},2,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":139},"100558441","peripheral-mononuclear-cells-to-screen-monitor-and-stratify-the-population-at-risk-of-osteoporosis-and-fractures-100558441","NCT06551155","Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures","Identification, Monitoring, and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood","DISCERN","Inclusion Criteria:\n\n* Healthy patients (at risk and undergoing periodic follow-up and\u002For attending outpatient visits for preventive screening)\n* Osteopenic patients with an available DXA\n* Osteoporotic patients (fractured and non-fractured) with an available DXA or, for fractured patients, a DXA prescribed as part of clinical practice\n* Aged ≥ 40 years of both sexes\n* Body Mass Index (BMI) between 18.5 and 29.9\n\nExclusion Criteria:\n\n* Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias)\n* Coagulation disorders (hereditary or secondary to other disorders)\n* Infections (including HIV-HBV-HCV positivity)\n* Neoplastic diseases (primary and\u002For secondary tumors)\n* Pregnancy or breastfeeding\n* Alcohol consumption (\\>20 g of alcohol per day currently or in the past)\n* Smoking (\\>10 cigarettes per day, currently or in the past)\n* Diabetes\n* Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)","40 Years",{"count":150,"type":22},120,"Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.",[153,154,155],"Osteoporosis","Osteopenia","Osteoporosis Fracture",[157,158,159],"peripheral blood mononuclear cells","screening","diagnosis","2026-05-25",{"date":162,"type":37},"2026-05-28",{"date":164,"type":37},"2024-08-05",{"date":166,"type":22},"2027-02-20",{"name":43,"class":44},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":45},"100420286","compliance-with-proms-detection-through-digital-support-and-correlation-compared-standard-to-outpatient-detection-in-knee-prosthetics-100420286","NCT04752761","Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics","Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto Alla Rilevazione Ambulatoriale Nella Protesica di Ginocchio","DIG-PROMs-k","Inclusion Criteria:\n\n* patients with gonarthrosis with indication of hip arthroplasty\n* males and females aged 18-78 and with a Barthel scale score ≥ 91\n* patients in possession of private digital electronic support (smartphone, tablet or PC)\n\nExclusion criteria:\n\n* patients with a Barthel scale score ≤ 90\n* patients with psychiatric pathologies, a history of drug and alcohol abuse\n* patients not in possession of private digital electronic support","78 Years",{"count":178,"type":22},50,[25],"Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.",[182,183],"Approach-Approach Conflict","Knee Discomfort",[185,186,187,188],"PROMs","Digital","Knee prosthesis","Oxford knee score","2026-05-21",{"date":191,"type":37},"2026-05-26",{"date":193,"type":37},"2020-11-30",{"date":195,"type":22},"2027-12-31",{"name":43,"class":44},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":45},"100553220","evaluation-of-clinical-and-radiographic-findings-in-patients-treated-surgically-for-biceps-long-head-injury-100553220","NCT06483256","Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury","Artro-Bic","Inclusion Criteria:\n\n* Age ≥ 18 at the time of distal biceps tendon repair surgery\n* Surgery performed within 30 days of injury\n* Patients treated surgically for distal biceps tendon injury by arthroscopy-assisted technique at the Shoulder-Elbow Department of the Rizzoli Orthopedic Institute from January 01, 2017 to December 31, 2022.\n\nExclusion Criteria:\n\n* \\\u003C 18 years old at the time of surgery\n* Patients who have presented non-surgery-related problems to the operated limb in the years following surgery such as fractures or subsequent episodes of tendon injury.\n* Patients treated for distal biceps tendon injury by different surgical techniques",{"count":205,"type":22},30,[25],"This is an interventional, single-center study with clinical and radiographic evaluation, at follow-up of at least 2 years, of patients treated surgically with arthroscopy-assisted distal biceps tendon repair at the Rizzoli Orthopaedic Institute. The study consists of 2 phases (Identification of includable patients, Follow-up visit:\n\n* identification by trained medical staff of subjects who meet the study inclusion criteria\n* Patients, after signing informed consent, will be evaluated clinically and radiographically by radiography in lateral and anteroposterior projection at the follow-up visit by specialized medical personnel. A clinical examination will be performed, with subjective and objective evaluation questionnaires administered, and a strength assessment of the operated limb and contralateral limb will be performed using specific dynamometers on the same date as the radiography is performed at the Rizzoli Orthopedic Institute. The radiographic study with standard projections (AP and LL) is used to evaluate any signs of anchor loosening and\u002For presence of heterotopic ossifications (which can limit movement and represent one of the main complications).\n\nStudy-specific radiographs will be performed on the same day as the outpatient clinical evaluation in consultation with the Radiology Service Manager.",[209],"Bicep Tendon Rupture","2026-05-20",{"date":212,"type":37},"2026-05-22",{"date":214,"type":37},"2024-11-13",{"date":216,"type":22},"2026-12",{"name":43,"class":44},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":226,"sex":227,"minAge":228,"maxAge":99,"enrollmentInfo":229,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":139},"100536894","clinical-validation-of-bbct-hip-100536894","NCT06270758","Clinical Validation of BBCT-hip","Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction","ValidaBBCT-hip","Inclusion Criteria:\n\n* caucasic post-menopausal women resident in Emilia-Romagna\n* menopause (\\>= 45 years)\n\nExclusion Criteria:\n\n* tumours\n* not free living\n* Chronic diseases with severe organ failure \u002F endocrine diseases of parathyroid, thyroid, adrenal gland \u002F intestinal malabsorption, osteomalacia \u002F Paget bone \u002F rheumatoid arthritis. Neurodegenerative diseases\n* Long-term continuous therapy (\\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors\n* Previous femur fractures\n* Presence of hip\u002Fknee prosthesis\n\nonly for the fracturegroup:\n\n* presence of fixation devices after the fracture\n* femur fracture due to high energy trauma",true,"FEMALE","65 Years",{"count":230,"type":22},300,"The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.",[153],[234,235,236,237,238],"hip fracture","fracture prediction","finite element","in silico","osteoporotic fracture",{"date":212,"type":37},{"date":241,"type":37},"2023-11-07",{"date":243,"type":22},"2030-11-06",{"name":43,"class":44},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":45},"100532198","carbofix-pedicle-screw-system-evaluation-of-the-clinical-and-radiographic-outcomes-of-the-use-of-a-carbon-fiber-device-compared-to-titanium-devices-in-patients-undergoing-spinal-arthrodesis-for-degenerative-spinal-diseases-100532198","NCT06209684","Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases","Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases","Inclusion Criteria:\n\n* Patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels;\n* Age greater than or equal to 18 years;\n* Ability to understand and sign the informed consent to the study and to follow the required follow-ups.\n\nExclusion Criteria:\n\n* Metabolic bone disease.\n* History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia.\n* Neoplastic disease.\n* History of mental disorder or current psychiatric treatment.\n* Pregnancy.\n* Immunodeficiency diseases.\n* Infectious bone disease (discitis, osteomyelitis)\n* Treatment with drugs that can interfere with bone metabolism\n* Inability to understand and sign the informed consent to the study and to follow the required follow-up visits.\n* Alcohol and\u002For drug abuse\n* Obesity\n* Metal allergy\n* Participation in other studies on drugs or devices (within 30 days)",{"count":253,"type":22},118,[25],"Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI\u002FCT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies.\n\n118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.",[257],"Degenerative Disc Disease",[259],"degenerative spine disease",{"date":212,"type":37},{"date":262,"type":37},"2022-04-29",{"date":264,"type":22},"2027-04-29",{"name":43,"class":44},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":277,"studyType":78,"phases":4,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":45},"100530616","treatment-of-low-flow-venous-malformations-with-electrosclerotherapy-prospective-observational-study-100530616","NCT06189092","Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study","Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico","BESVAM","Inclusion Criteria:\n\n* Diagnosis of low-flow venous malformations eligible for electrosclerotherapy\n* Non-indication for embolizing treatment\n* Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.\n\nExclusion Criteria:\n\n* Previous treatment for \\\u003C 30 days\n* Pregnancy and lactation status\n* Patients of childbearing age without contraceptive use\n* Presence of metal synthetic media\n* COPD with FiO2 \\\u003C 30 mmHg\n* Impaired renal function with eGFR\\\u003C30 ml\u002Fmin\u002F1.73mq\n* Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related\n* Patients who have already received a cumulative dose of Bleomycin ≥100 mg\n* Patients who have undergone prior thoracic radiotherapy\n* Patients with a history of seizures and epilepsy","16 Years",{"count":276,"type":22},65,"1 Year","Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.",[280],"Vascular Malformations",[282],"Electrosclerotherapy",{"date":212,"type":37},{"date":285,"type":37},"2023-10-28",{"date":287,"type":22},"2027-11-28",{"name":43,"class":44},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":45},"100525269","endothelial-damage-in-major-spine-surgery-measured-by-circulating-syndecan-1-an-observational-studyglycortho-100525269","NCT06119542","Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)","Endothelial Glycocalyx Damage in Major Spine Surgery, as Measured by Circulating Syndecan-1 Levels: a Prospective Observational Pilot Study.(GlycOrtho)","GlycOrtho","Inclusion Criteria:\n\n* Undergoing Major Spine Surgery with estimated blood loss\\> 25% of total blood volume\n* American Society of Anesthesiology status 1-2-3\n* Able to comprehend and sign informed consent.\n* If age \\\u003C18 years: parent or legal representative able to comprehend and sign informed consent\n\nExclusion Criteria:\n\n* Surgery outside of laboratory opening hours\n* Patients undergoing spine surgery for genetic syndromes\u002Fneuromuscular scoliosis","12 Years","75 Years",{"count":205,"type":22},"The goal of this observational study is to learn about endothelial damage in major spine surgery, expressed as rise in circulating Syndecan-1.\n\nThe main questions it aims to answer are:\n\n* What is the extent of endothelial glycocalyx shedding in major spine surgery?\n* Are there differences in different type of surgical populations? (adolescent idiopathic scoliosis, adult degenerative spine disease, oncologic surgery)\n\nTo do so, blood samples will be drawn from participants at the following timepoints:\n\n* basal\n* after surgery\n* if transfusion of Fresh Frozen Plasma: before and after transfusion\n* Post-Operative Day 1-2-4",[302],"Spinal Fusion",[304,305,306,307],"Endothelium","Syndecan-1","Surgery","Glycocalyx",{"date":212,"type":37},{"date":310,"type":37},"2026-02-28",{"date":312,"type":22},"2026-09-30",{"name":43,"class":44},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":176,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":334,"locationsCount":45},"100420036","compliance-with-proms-detection-through-digital-support-and-correlation-compared-to-standard-outpatient-proms-detection-in-hip-prosthetics-dig-proms-h-100420036","NCT04749511","Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)","Compliance al Rilevamento PROMs Mediante Supporto Digitale e Correlazione Rispetto al Rilevamento PROMs Ambulatoriale Standard Nella Protesica d'Anca","DIG-PROMs-h","Inclusion Criteria:\n\n* patients with coxarthrosis with indication of hip arthroplasty\n* males and females aged 18-78 and with a Barthel scale score ≥ 91\n* patients in possession of private digital electronic support (smartphone, tablet or PC)\n\nExclusion criteria:\n\n* patients with a Barthel scale score ≤ 90\n* patients with psychiatric pathologies, a history of drug and alcohol abuse\n* patients not in possession of private digital electronic support",{"count":178,"type":22},[25],"Two methods for detecting outcomes after hip prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (WOMAC Score) VS detection using digital questionnaires created on Google Forms and sent to the patient's smartphone on which the compilation takes place in the extra area outpatient.",[326],"Quality of Life",[185,186,328,329],"Hip prosthesis","WOMAC score",{"date":212,"type":37},{"date":193,"type":37},{"date":333,"type":22},"2027-03-01",{"name":43,"class":44},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":228,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":45},"100418585","study-of-parameters-of-osteosarcopenia-in-patients-with-hip-fracture-100418585","NCT04730622","Study of Parameters of Osteosarcopenia in Patients With Hip Fracture","Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck","Inclusion Criteria:\n\n* Patients who came to observation with femoral neck fracture of possible osteoporotic nature (no or minimal trauma) to be treated with endoprosthesis or hip arthroplasty.\n* Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).\n\nExclusion Criteria:\n\n* Previous osteoporotic fractures\n* Previous prosthetic surgery for orthopedic diseases\n* Pre-existing clinical conditions that led to permanent immobility\n* Neoplastic diseases\n* Autoimmune diseases\n* Severe myopathies\n* Chronic viral infections (HBV, HCV, HIV);\n* Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin\n* Paget's disease",{"count":343,"type":22},100,"The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck. The control group will consist of patients undergoing a hip replacement for osteoarthritis, as the decrease in muscle function and bone quality is less severe in this condition than in osteoporosis.",[346,347],"Osteoporotic Fracture of Femur","Osteoarthritis, Hip",[153,349,328],"Sarcopenia",{"date":212,"type":37},{"date":352,"type":37},"2020-11-23",{"date":354,"type":22},"2026-12-31",{"name":43,"class":44},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":226,"sex":17,"minAge":18,"maxAge":176,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":45},"100352525","total-knee-arthroplasty-fast-track-protocol-is-the-future-100352525","NCT03869996","Total Knee Arthroplasty: Fast Track Protocol is the Future?","Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty","FastTrack-G","Inclusion Criteria:\n\n* patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty\n* BMI \\\u003C 32\n* Time up ang go test \\\u003C\u002F= 12 seconds\n* American Society of Anesthesiologists physical status classification system (ASA) \\\u003C\u002F= 2\n* preoperative hemoglobin (HB) \\>13 g\u002Fdl\n* patients eligible for spinal anesthesia\n* presence of a care-giver\n\nExclusion Criteria:\n\n* psychiatric diseases\n* preoperative use of crutches\n* ASA \\> 3\n* preoperative HB \\\u003C 13 g\u002Fdl",{"count":365,"type":22},64,[25],"Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.",[58,106],[370,371],"fast track care","total knee arthroplasty",{"date":212,"type":37},{"date":374,"type":37},"2019-02-25",{"date":376,"type":22},"2026-11-01",{"name":43,"class":44},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":388,"studyType":78,"phases":4,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":45},"100638345","retrospective-and-prospective-evaluation-of-hip-short-stem-performed-by-anterior-approach-100638345","NCT07600632","Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach","Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study","AMISP","Inclusion Criteria:\n\n* Diagnosis of primary hip osteoarthritis or osteonecrosis\n* Minimally invasive direct anterior approach\n* Cementless femoral component\n* Minimum follow-up of 2 years\n* Patient willingness to participate in the study with written informed consent\n* Age over 18 years\n* Male or female patients\n\nExclusion Criteria:\n\n* Other diagnoses of secondary hip osteoarthritis\n* Non-anterior surgical approach\n* Cemented or other types of components\n* Patient unwillingness to participate in the study\n* Inadequate clinical and radiological documentation",{"count":387,"type":22},400,"5 Years","This study aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA). Short femoral stems have been developed to preserve proximal femoral bone stock, potentially provide a more physiological load transfer, and facilitate implantation through less invasive surgical exposures, particularly in younger and more active patients.\n\nThe stem is a cementless hydroxyapatite-coated triple-tapered short stem, has been previously used because its design allows simplified femoral canal preparation and easier implant insertion during minimally invasive anterior approaches, where femoral exposure may be technically demanding. However, previous reports have shown conflicting results regarding implant survivorship and radiographic outcomes, including increased rates of radiolucent lines, pedestal formation, and stem subsidence, particularly among younger and more active patients.\n\nThe present study will investigate the technical and clinical implications of using short femoral stems through a minimally invasive anterior approach. Primary outcomes will include perioperative complication rates, wound characteristics, peri-incisional tissue condition, postoperative bleeding, and other surgery-related complications. Secondary outcomes will include postoperative pain, functional recovery, clinical outcome scores, implant survivorship, and serial radiographic findings at short- and mid-term follow-up.\n\nGiven the limited evidence currently available regarding the short- and mid-term performance of short femoral stems implanted through the direct anterior approach, this study aims to provide a comprehensive clinical and radiographic evaluation of these implants over time. Adverse events will be continuously monitored through scheduled clinical and radiographic assessments.",[391],"Hip Arthritis","2026-05-18",{"date":210,"type":37},{"date":395,"type":37},"2025-09-12",{"date":397,"type":22},"2030-12",{"name":43,"class":44},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":45},"100635760","descriptive-analysis-of-surgeries-in-patients-with-multiple-osteochondromas-100635760","NCT07556874","Descriptive Analysis of Surgeries in Patients With Multiple Osteochondromas","Analisi Descrittiva di Chirurgie in Pazienti Con Osteocondromi Multipli","CHIROS","Inclusion Criteria:\n\n* Patients diagnosed with multiple osteochondromas who underwent surgery at the IOR between January 1, 2012, and February 28, 2025.\n* Patients of both sexes, regardless of age.\n\nExclusion Criteria:\n\n\\- Patients with conditions that are part of the differential diagnosis for the condition under study, such as enchondromatosis and solitary exostosis.",{"count":230,"type":22},"Multiple Osteochondromas (MO), also known as Multiple Cartilaginous Exostoses, is an autosomal dominant skeletal disorder with an incidence of approximately 1 in 50,000 in Western populations. Most cases are associated with pathogenic variants in the EXT1 and EXT2 genes, which lead to a systemic reduction of heparan sulfate, causing abnormalities in bone growth and other physiological processes.\n\nSymptoms typically appear in childhood and include the development of bony protrusions often associated with pain due to compression of muscles and nerves. Patients are generally shorter than average and may experience dislocations, subluxations, reduced motor function, and skeletal deformities such as genu valgum, limb asymmetry, and scoliosis. The most severe complication is malignant transformation into chondrosarcoma, occurring in 0.5-5% of adult patients. Diagnosis is mainly based on imaging techniques (X-ray, CT, MRI, ultrasound) and is confirmed by the presence of at least two osteochondromas after excluding other conditions.\n\nFollowing diagnosis, patients or their caregivers often raise questions regarding disease progression, the number and type of surgical interventions required, and differences between pediatric and adult surgical approaches. This retrospective observational cohort study aims to characterize the number and types of surgical procedures performed in MO patients at a European referral center, the Rizzoli Orthopaedic Institute.",[410],"Multiple Osteochondroma",{"date":412,"type":37},"2026-05-15",{"date":414,"type":37},"2025-10-23",{"date":416,"type":22},"2028-10",{"name":43,"class":44},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":45},"100536717","arterial-chemoembolization-for-the-treatment-of-desmoid-fibromatosis-100536717","NCT06268457","Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis","Chemioembolizzazione Arteriosa Per il Trattamento Della Fibromatosi Desmoide: Studio Osservazionale Prospettico","Embodesmo","Inclusion Criteria:\n\n* FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)\n* Patients who are not candidates for surgery or cryoablation\n\nExclusion Criteria:\n\n* Patients with life expectancy \\\u003C3 months or severely impaired status functional status (ASA 4)\n* Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT)\n* Patients with coagulation deficiency or plateletopenic disease\n* Patients with documented active infection",{"count":427,"type":22},20,"Desmoid fibromatoses are rare (1-2 cases\u002Fmillion per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.\n\nThe current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.",[430],"Desmoid",[432],"Chemoembolization","2026-05-11",{"date":435,"type":37},"2026-05-14",{"date":437,"type":37},"2024-02-20",{"date":439,"type":22},"2028-02-01",{"name":43,"class":44},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":456,"leadSponsor":458,"locationsCount":45},"100533320","radiomics-compared-with-conventional-response-criteria-for-predicting-progression-of-desmoid-tumor-after-cryoablation-100533320","NCT06224283","Radiomics Compared With Conventional Response Criteria for Predicting Progression of Desmoid Tumor After Cryoablation","Confronto Tra Radiomica e i Criteri Convenzionali di Risposta Nella Previsione Della Progressione Del Tumore Desmoide Dopo Crioablazione","Cryomics","Inclusion Criteria:\n\n* desmoid tumor treated at Rizzoli Orthopaedic Institute with cryoablation\n* baseline MRI\n* clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up\n\nExclusion Criteria:\n\n\\- not meeting inclusion criteria",{"count":450,"type":22},21,"Desmoid tumors (DT) are uncommon tumors that arise from musculoaponeurotic structures. Despite benign, they can cause pain and disability due to their tendency to be locally aggressive. Cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic DT. This involves repeated cycles of freezing, leading to cell death. Recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.Although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Nevertheless, MRI can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. These changes in heterogeneity can be quantified using a radiomics approach. The aim of this study is to develop radiomics response criteria dedicated to the evaluation of DT treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to RECIST 1.1.",[430],{"date":454,"type":37},"2026-05-12",{"date":437,"type":37},{"date":457,"type":22},"2026-10-31",{"name":43,"class":44},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":277,"studyType":78,"phases":4,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":45},"100530615","arterial-embolization-for-the-treatment-of-bone-metastases-prospective-observational-study-100530615","NCT06189079","Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study","Embolizzazione Arteriosa Per il Trattamento Delle Metastasi Ossee: Studio Osservazionale Prospettico","EMBONEMET","Inclusion Criteria:\n\n* Patients of either sex of age or older who are candidates for embolization therapy\n* Life expectancy \\> 3 months\n* Single metastatic or oligometastatic.\n* Plurimetastatic if a particular site is causing painful symptoms or at risk for pathologic rupture\n\nExclusion Criteria:\n\n* Patients with life expectancy \\\u003C3 months or severe functional status impairment (ASA 4)\n* Patients with hypovascular metastasis documented by angiography or MRI perfusion study with MDC.\n* Patients with coagulation deficiency or plateletopenic patients.\n* Patients with documented active infection.",{"count":468,"type":22},60,"To date, arterial embolization constitutes one of the most popular methods in minimally invasive treatment of bone metastases, allowing good results in terms of pain reduction, local control of disease and reduction of peri-operative bleeding, with low invasiveness.",[471],"Bone Metastases",[473],"Arterial embolization",{"date":454,"type":37},{"date":476,"type":37},"2023-05-10",{"date":478,"type":22},"2028-08",{"name":43,"class":44},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":45},"100573398","virtual-reality-for-anxiety-in-interventional-radiology-procedures-100573398","NCT06745765","Virtual Reality for Anxiety in Interventional Radiology Procedures","Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study","VR-IR","Inclusion Criteria:\n\n* Indication to CT-guided biopsy in local anesthesia\n* Informed consent signature\n\nExclusion Criteria:\n\n* Lack of patient consent to trial.\n* Lack of eligibility to perform CT-guided needle biopsy, or eligibility to perform the procedure but with administration of general anesthesia or sedation.\n* patients who do not speak Italian or English will be excluded;\n* patients with visual and\u002For hearing impairment;\n* patients on analgesics or anxiolytics;\n* patients with the following conditions: dementia, psychiatric disorders; headache, dizziness, recent head injury, epilepsy, and other conditions in which the application of VR glasses has been judged to be potentially harmful; and when the topical anesthetic (lidocaine and prilocaine \\[eutectic mixture of local anesthetic (EMLA)\\]) or tetracaine (Ametop) was not properly applied before surgery.",{"count":489,"type":22},236,[25],"The goal of this clinical trial is to learn if virtual reality works to reduce anxiety in patients undergoing interventional radiology procedures. The main questions it aims to answer are:\n\nDoes virtual reality lower anxiety in patients undegoing minimally invasive procedures? Can it help the platient's compliance and operators' satisfaction? Researchers will compare virtual reality to usual preoperative care to see if virtual reality is effective.\n\nParticipants will:\n\nUse virtual reality for 20 minutes before the intervention starts. Complete questionnaires before and after the procedure.",[493],"Preoperative Anxiety",[495,496],"Virtual reality","Preoperative care","2026-05-08",{"date":433,"type":37},{"date":500,"type":37},"2024-11-01",{"date":216,"type":22},{"name":43,"class":44},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":512,"conditions":513,"keywords":518,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":528,"locationsCount":45},"100636749","fibrous-dysplasia-an-epidemiological-and-correlational-evaluation-of-multimodal-data-100636749","NCT07569731","Fibrous Dysplasia: An Epidemiological and Correlational Evaluation of Multimodal Data","Fibrous Dysplasia: An Epidemiological and Correlational Study of Anthropometric, Clinical, Treatment, and Genetic Data","FIBR DYSPLASIA","Inclusion Criteria:\n\n* All patients affected by Fibrous Dysplasia, McCune-Albright syndrome and Mazabraud syndrome (retrospectively included from 2009)\n* Availability of clinical and radiological data collected during their recovery at the IOR\n* Availability of tumor tissue in the biobank in sufficient quantity and quality\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria",{"count":77,"type":22},"Fibrous dysplasia is a benign, pseudotumoral, genetic but non-hereditary condition characterized by the presence of one or more areas of abnormal bone development in which the normal structure is replaced by fibrous tissue. It is an extremely heterogeneous condition, as it can be monostotic, polyostotic, or panostotic, or it may occur within the context of more complex syndromes such as McCune-Albright syndrome (in which polyostotic fibrous dysplasia is associated with café-au-lait spots and precocious puberty) or Mazabraud syndrome (in which intramuscular myxomas are present).\n\nThis condition is caused by post-zygotic missense mutations, so it is never hereditary, and the affected individual will constitute a so-called \"genetic mosaic,\" a fact that explains the wide variability in the localization of the pathological areas. The mutations in question occur in a gene (GNAS) located on chromosome 20 (20q13.2-13.3); this gene encodes a G protein with GTPase activity, the function of which is consequently impaired.\n\nThe aim of this study is to evaluate in detail the characteristics of the patients, their hospitalizations, and related interventions. Given the rarity of the condition, such investigations are often conducted on very limited datasets. The present study is expected to include over 200 patients, providing a comprehensive picture.\n\nAn additional aim is to assess the impact of somatic mutations in the GNAS gene and their impact in terms of clinical manifestations.",[514,515,516,517],"Fibrous Dysplasia","Fibrous Dysplasia of Bone","Fibrous Dysplasia\u002FMcCune-Albright Syndrome","Mazabraud Syndrome",[514,519,517,520,521,522],"McCune-Albright Syndrome","Surgical procedures","GNAS","Pain","2026-05-07",{"date":454,"type":37},{"date":526,"type":37},"2022-05-12",{"date":34,"type":22},{"name":43,"class":44},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":535,"maxAge":298,"enrollmentInfo":536,"targetDuration":538,"studyType":78,"phases":4,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":45},"100636758","outcomes-of-surgical-treatment-using-a-custom-made-device-for-total-ankle-and-talar-replacement-in-the-management-of-severe-cases-of-bone-loss-or-bone-compromise-a-pilot-study-100636758","NCT07569848","Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.","\\*\\*INCLUSION CRITERIA:\\*\\*\n\n1. Male or female patients aged between 35 and 75 years.\n2. Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.\n3. Severe cases of bone loss or talar bone compromise.\n4. Customisation performed at the Rizzoli Orthopaedic Institute.\n5. Signed informed consent for participation in the study.\n6. Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.\n\n\\*\\*EXCLUSION CRITERIA:\\*\\*\n\n1. Patients unable to understand or provide informed consent.\n2. Pregnant women.\n3. Body mass index (BMI) \\> 40.\n4. Refusal to sign the informed consent form for study participation.\n5. Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.\n6. Known hypersensitivity to device materials.\n7. Active or suspected latent infection in or around the affected ankle joint.\n8. Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).\n9. Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.\n10. Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.\n11. Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., \\>30 days).\n12. Pregnant and\u002For fertile women.","35 Years",{"count":537,"type":22},26,"36 Months","On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation.\n\nRecently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible.\n\nThe customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process.\n\nThe aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.",[541,542,543],"Arthrosis","Ankle Arthritis","Ankle Replacement","2026-04-29",{"date":546,"type":37},"2026-05-06",{"date":548,"type":37},"2022-02-11",{"date":550,"type":22},"2031-03",{"name":43,"class":44},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":45},"100636757","clinical-and-radiological-evaluation-over-10-years-after-bilateral-subtalar-arthrorisis-surgery-with-endorthesis-and-calcaneal-stop-for-the-correction-of-pediatric-flatfoot-100636757","NCT07569835","Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot","ARTRO-LONG","INCLUSION CRITERIA:\n\nPatients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study \"Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop\" by Prof. Giannini, still in follow-up at IOR.\n\nEXCLUSION CRITERIA:\n\nPatients who have undergone subsequent surgical procedures on the foot and ankle",{"count":427,"type":22},"VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle).\n\nThe secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope.\n\nTIP-TOE TEST:\n\nThe patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe.\n\nJACK TEST:\n\nThis consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible.\n\nTIP-TOE WALKING TEST:\n\nThe patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch.\n\nMEARY'S ANGLE:\n\nMeasured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph.\n\nTALOCALCANEAL ANGLE:\n\nMeasured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.\n\nVAS:\n\nThe Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).\n\nPODOSCOPE FOOTPRINT ASSESSMENT:\n\nEvaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot.\n\nSAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available.\n\nENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent.\n\nDATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents.\n\nA dedicated data collection form will be used to record clinical information and the results of the analyses by the study.\n\nFor each enrolled patient, a Case Report Form (CRF) will be completed.",[562],"Flat Foot Acquired Bilateral (Pes Planus)",{"date":546,"type":37},{"date":565,"type":37},"2024-05-30",{"date":567,"type":22},"2026-05",{"name":43,"class":44},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":226,"sex":17,"minAge":18,"maxAge":18,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":45},"100636601","sensitivity-and-tests-for-evaluation-of-plantar-fasciopathy-100636601","NCT07567807","Sensitivity and Tests for Evaluation of Plantar Fasciopathy","STEP","Inclusion Criteria:\n\n* PF group:\n\n  * Patients on the waiting list at Clinic I of the Rizzoli Orthopaedic Institute for surgical intervention with a diagnosis of recalcitrant PF lasting at least 12 months\n  * Age \\>18 years\n  * MRI of the foot and ankle negative for other local causes of pain included in the differential diagnosis of PF\n  * Negative electromyography for tarsal tunnel syndrome\n* Control group:\n\n  * Age \\>18 years\n  * Outpatients followed at Clinic I for conditions unrelated to the foot and ankle, with no clinical history of foot pain or pathology in the preceding 12 months\n\nExclusion Criteria:\n\n* PF and control groups:\n\n  * Minor patients\n  * Patients with diagnosed rheumatologic diseases currently under pharmacological treatment\n  * Patients with diabetes or diabetic neuropathy\n  * Pregnant women",{"count":577,"type":22},45,[25],"Plantar fasciopathy (PF), one of the leading causes of foot pain, affects up to one in ten individuals in their lifetime. Characterized by pain and structural alterations at the proximal insertion of the plantar fascia on the calcaneus, the term \"PF\" has replaced \"plantar fasciitis,\" as degenerative tissue changes predominate over inflammatory processes.\n\nThe pathogenesis of PF remains incompletely understood but appears to involve the gastrocnemius muscle, which is part of an integrated biomechanical unit including the calcaneus and the plantar fascia. Diagnosis is primarily based on clinical history and physical examination, while imaging modalities such as ultrasound and magnetic resonance imaging assist in excluding differential diagnoses. A simple clinical test to distinguish PF from other causes of heel pain, such as plantar fat pad syndrome or Baxter's nerve entrapment, could improve diagnostic efficiency.\n\nGiven the biomechanical relationship between the Achilles tendon and the plantar fascia, and their shared association with gastrocnemius tightness, a clinical test adapted from Achilles tendon assessment may be useful for diagnosing PF. In 2003, the Royal London Hospital proposed a diagnostic approach for Achilles tendinopathy based on pain reduction during active ankle dorsiflexion, which reduces tension in the tendon. The same concept could be applied, with appropriate modifications, to PF.\n\nThe present study aims to evaluate the sensitivity, specificity, reproducibility, and predictive value of localized tenderness at the medial calcaneal tuberosity and of a modified version of the Royal London Hospital Test in patients with PF. Secondarily, it will assess the reproducibility and prevalence of the Silfverskiöld test, supporting the concept of a biomechanical unit involving the triceps surae, calcaneus, and plantar fascia.\n\nAim of this study is to evaluate the sensitivity, specificity, reproducibility, and predictive value of tenderness at the medial calcaneal tuberosity and of a modified version of the Royal London Hospital Test in patients presenting with clinical signs of PF. The modified version of the Royal London Hospital Test for PF has not yet been formally validated in the literature. However, the study was designed following the methodology adopted by Prof. Maffulli for the validation of the original test. Therefore, this is an exploratory study aimed at collecting preliminary data on this new diagnostic test. The secondary objectives of this study is to evaluate the reproducibility and prevalence of the Silfverskiöld test in the study population.",[581],"Plantar Fasciitis, Chronic",[583,584],"plantar fasciopathy","Silfverskiöld test","2026-04-28",{"date":587,"type":37},"2026-05-05",{"date":589,"type":37},"2025-04-01",{"date":312,"type":22},{"name":43,"class":44},""]