[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453955":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"percutaneous osteosynthesis and cementoplasty procedure",null,"Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.\n\nPatients have assessed for pain and quality of life during consultations as part of an interventional radiology procedure (pre-procedure consultation, and follow-up consultations at 1, 3, 6 and 12 months after the procedure.",[13,14,15],"Other: EQ5D (EuroQol 5 Dimensions)","Other: Numerical Rating Scale (NRS)","Other: evaluated the consumption of analgesics",[17,23,29],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"EQ5D (EuroQol 5 Dimensions)","The evaluation of the quality of life was conducted with the EQ5D (EuroQol 5 Dimensions) score (min 0: bad health and max:100 good health).",[9],[22],"evaluation of the quality of life",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Numerical Rating Scale (NRS)","the type and intensity of pain will be evaluated by Numerical Rating Scale (NRS) from 0 to 10 in different positions and in different activities (e.g. background pain, general maximum\u002Fminimum pain, pain of the site treated by the procedure, pain at rest, in lying position, in sitting position, in standing position, at bearing weight, in walking, description of painful irradiations, nocturnal awakenings).",[9],[28],"evaluation of the type and intensity of pain",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"evaluated the consumption of analgesics","the consumption of analgesics by step and by dosage will be evaluated.",[9],[34],{"name":35,"affiliation":5,"role":36},"Sylvain GRANGE, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","(0)477829066","+33","Sylvain.Grange@chu-st-etienne.fr",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":42},"Sylvain BERTHOLON, resident",[46],{"facility":47,"status":48,"city":49,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHU Saint-Etienne","RECRUITING","Saint-Etienne","France","FR",{"type":53,"coordinates":54},"Point",[55,56],4.39,45.43389,{"lat":56,"lon":55},[59],{"name":35,"role":36,"phone":10,"phoneExt":10,"email":10},{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100453955","combination-of-percutaneous-screw-fixation-and-cementoplasty-for-lytic-bone-metastases-100453955",false,"NCT05191264","Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases","Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study","Inclusion Criteria:\n\n* patients who received osteosynthesis\u002Fcementoplasty for Lytic Bone Metastases\n\nExclusion Criteria:\n\n* patient's refusal to participate","ALL","18 Years",{"count":72,"type":73},150,"ESTIMATED","OBSERVATIONAL","In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.\n\nAnalgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.\n\nCementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).\n\nFixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.",[77],"Interventional Radiology",[79,80,81,82],"Screw fixation","cementoplasty","interventional radiology","pain management","2025-03-17",{"date":85,"type":86},"2025-03-18","ACTUAL",{"date":88,"type":86},"2019-07-10",{"date":90,"type":73},"2026-06",{"name":5,"class":6},1]