[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innoprod Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100577601","performance-and-safety-of-the-innofix-screw-if25-100577601",false,"NCT06800417","Performance and Safety of the Innofix® Screw (IF25)","Performance and Safety of the Innofix® Screw as Part of Stabilization of a Non-displaced Pathologic Fracture (Complete or Impending) of the Pelvic Bone of Cancer Patients by Mini-invasive Percutaneous Fixation by Internal Cemented Screw","IF25","Inclusion Criteria:\n\n* The patient is 18 years old or more\n* The patient is a cancer patient\n* The patient needs a stabilization of a non-displaced pathologic fracture (complete or impending) of the pelvic bone\n* The patient is symptomatic with musculoskeletal pain exacerbated during movement or weight bearing\n* The patient has been informed and he has signed the informed consent\n* The patient must be willing and able to comply with all study requirements including follow-up visits and radiographic assessments\n* The patient is affiliated with the French social security system\n\nExclusion Criteria:\n\n* The patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation\n* The patient is a pregnant woman or considered getting pregnant during its investigation participation\n* The patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator)\n* The patient has got one or more contraindications to general anaesthesia\n* The patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation\n* The use of the InnoFix® screw can interfere with anatomical structures or physiological performances\n* The patient has got an insufficient tissue coverage at the surgical site\n* The patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site\n* The patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications\n* The patient is allergic and\u002For hypersensitive to a component of the InnoFix® modules, of the InnoTool™ instruments and to the used cement\n* The patient has got a haemostasis disorder ((INR \\>1.5, platelets \\\u003C50x109\u002FL)\n* The patient participates to another clinical investigation\n* The patient's life expectancy is lower than 6 months\n* The patient is under guardianship, curatorship or legal protection\n* The patient is deprived of liberty by a judicial or administrative decision","ALL","18 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) \u002F Technical performances (Percutaneous implantation by mini-invasive approach, Efficiency of percutaneous implementation and efficiency of percuatneous cementing) \u002F Safety performances (Preservation of the screw stability after implantation and preservation of the screw integrity after implantation). The safety and performance data about the InnoFix® screw will be used to obtain their CE marking according to the regulation (EU) 2017\u002F745.\n\nThe principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.",[27],"Pathologic Fracture",[29,30,31],"FICS","Pelvis","Cancer","NOT_YET_RECRUITING","2025-01-29",{"date":35,"type":36},"2025-01-30","ACTUAL",{"date":38,"type":21},"2025-05",{"date":40,"type":21},"2026-05",{"name":42,"class":43},"Innoprod Medical","INDUSTRY",""]