[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481933":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":62,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":100,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Inion Oy","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CompressOn group","EXPERIMENTAL","125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws.",[13],"Procedure: Operation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Operation","Bone fixation operation in foot or ankle area using bioabsorbable headless screw\u002Fs",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Mäenpää","Tampere University Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Marika Manni, MD","CONTACT","+358 50 366 9994","marika.manni@inion.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Kati Marttinen","+358 40 841 6217","kati.marttinen@inion.com",[37],{"facility":24,"status":38,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Tampere","33520","Finland","FI",{"type":44,"coordinates":45},"Point",[46,47],23.78712,61.49911,{"lat":47,"lon":46},[50,54,57,59,61],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":53},"Heikki Mäenpää, MD","+358 3 311 611","heikki.maenpaa@pshp.fi",{"name":55,"role":56,"phone":20,"phoneExt":20,"email":20},"Nikke Partio, MD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":20,"phoneExt":20,"email":20},"Outi Päiväniemi, MD",{"name":60,"role":56,"phone":20,"phoneExt":20,"email":20},"Evgenii Brushtein, MD",{"name":51,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100481933","performance-and-safety-evaluation-of-inion-compresson-screw-in-foot-and-ankle-surgeries-pmcf-investigation-100481933",false,"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","ALL","18 Years",{"count":74,"type":75},125,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Medial Malleolus Fracture","Lisfranc Injury","Lisfranc Fracture","Talus Fracture","Calcaneus Fracture","Navicular Fracture","Deformity, Foot","Ankle Fractures","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",[101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"bioabsorbable screw","compression screw","headless screw","orthopaedic screw","bone fixation","bioabsorbable screw study","resorbable","biodegradable","bioabsorbable","fracture fixation with resorbable implants","inion","post-market follow-up study","orthopedic bone fixation","arthrodesis","osteotomy","2026-03-11",{"date":118,"type":119},"2026-03-13","ACTUAL",{"date":121,"type":119},"2023-03-07",{"date":123,"type":75},"2032-04-30",{"name":5,"class":6},1]