[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inion Oy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100629382","performance-and-safety-follow-up-of-bioabsorbable-headless-inion-compressontm-screws-in-the-fixation-of-bone-fractures-in-ankle-knee-and-elbow-of-pediatric-and-adolescent-patients-100629382",false,"NCT07473947","Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients","Inclusion Criteria:\n\n1\\. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability \\\u003C 18 years 3. Suitable and in need for an operation indicated for subject device 4. Ability to give adequate input for the PROM questionnaires 5. Willingness and ability to comply with rehabilitation instructions. 6. Availability for follow-up visits.\n\nExclusion Criteria:\n\n1. Active infection\n2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb)\n3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)\n4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)\n5. Patients with known allergy to the implant constituents or its degradation products.\n6. Spinal and craniomaxillofacial indications.\n7. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation","ALL","17 Years",{"count":18,"type":19},80,"ESTIMATED","INTERVENTIONAL",[22],"NA","The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of pediatric and adolescent patients. The study aims to recruit 80 patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Lighthouse Hospital at Turku University Hospital (TYKS) in Finland. The main focus of the study in terms of performance is to follow up the bone healing\u002Fossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.",[25,26,27],"Ankle Fractures","Knee Fractures","Elbow Fractures",[29,30,31,32,33,34],"bioabsorbable","resorbable","ankle fracture","knee fracture","elbow fracture","fracture fixation","RECRUITING","2026-06-01",{"date":38,"type":39},"2026-06-03","ACTUAL",{"date":41,"type":39},"2026-05-29",{"date":43,"type":19},"2032-12",{"name":45,"class":46},"Inion Oy","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":59,"conditions":60,"keywords":79,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100481933","performance-and-safety-evaluation-of-inion-compresson-screw-in-foot-and-ankle-surgeries-pmcf-investigation-100481933","NCT05555459","Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation","The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle","Inclusion Criteria:\n\n1. Read the patient information bulletin on the study and signed the patient consent form\n2. Adult patient (over 18-year-old)\n3. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon\n4. Ability to fill in questionnaires.\n5. Willingness to comply with rehabilitation instructions.\n6. Availability for follow-up visits.\n\nExclusion Criteria:\n\n1. Active infection\n2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb\n3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)\n4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)\n5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation\n6. Patients with significant neuropathy\n7. Pregnancy\n8. Patients who refuse to participate\n9. Lower limb tumor or metastasis\n10. Complex Regional Pain Syndrome (CRPS) in operated foot","18 Years",{"count":57,"type":19},125,[22],"The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing\u002Fossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.",[61,62,63,64,65,66,67,25,68,69,70,71,72,73,74,75,76,77,78],"Medial Malleolus Fracture","Lisfranc Injury","Lisfranc Fracture","Talus Fracture","Calcaneus Fracture","Navicular Fracture","Deformity, Foot","Foot Fracture","Fractures, Bone","Fracture of Foot","Foot Deformities","Foot Injury","Feet Deformity Tarsus","Metatarsalgia","Hallux Rigidus","Hallux Valgus","Deformity of Toe","Deformity of Foot",[80,81,82,83,84,85,30,86,29,87,88,89,90,91,92],"bioabsorbable screw","compression screw","headless screw","orthopaedic screw","bone fixation","bioabsorbable screw study","biodegradable","fracture fixation with resorbable implants","inion","post-market follow-up study","orthopedic bone fixation","arthrodesis","osteotomy","2026-03-11",{"date":95,"type":39},"2026-03-13",{"date":97,"type":39},"2023-03-07",{"date":99,"type":19},"2032-04-30",{"name":45,"class":46},""]