[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"deformity-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:deformity-foot":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":45,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"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":19,"type":20},125,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"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",[46,47,48,49,50,51,52,53,54,55,56,57,58,59,60],"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","RECRUITING","2026-03-11",{"date":64,"type":65},"2026-03-13","ACTUAL",{"date":67,"type":65},"2023-03-07",{"date":69,"type":20},"2032-04-30",{"name":71,"class":72},"Inion Oy","INDUSTRY",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":73},"100488666","medial-displacement-calcaneal-osteotomy-and-fdl--transfer---with-a-human-allogeneic-cortical-bone-screw-100488666","NCT05643079","Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw","Medial Displacement Calcaneal Osteotomy and FDL- Transfer - a Prospective Comparative Study Between Metal\u002FBio-Tenodesis Screw (Arthrex) and the Human, Allogeneic Cortical Bone Screw (Shark Screw®️, Surgebright-GmbH)","Inclusion Criteria\n\n* Indication for the use of a metal\u002FBio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer.\n* BMI\\\u003C 40 kg\u002Fm²\n\nExclusion Criteria:\n\n* Insufficient knowledge of German\n* Alcohol and drug abuse\n* Pregnant woman or nursing mother\n* Foreseeable compliance problems\n* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis\n* Active osteomyelitis\n* History of foot surgery\n* Advanced osteoarthritis of the lower ankle joint\n* Ulcerations in the skin of the surgical area\n* Immunosuppressive medications that cannot be discontinued\n* BMI \\>40",{"count":82,"type":20},40,"OBSERVATIONAL","The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal\u002FBio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone.\n\nThe main questions it aims to answer are:\n\n* Can the human bone screw achieve union rates like the metal\u002FBio-Tenodesis screw?\n* Is the time to union similar between the different screws?\n* Is the complication rate similar between the different screws?\n* Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups?\n\nParticipants will have\n\n* the surgery\n* follow-ups at 6 weeks, 6 months, 1 and 2 years.\n* X-rays are performed at each follow up.\n* CT-scans are performed after 6 months.\n* activity scores are collected at the follow up after 6 months, 1 year and 2 years.",[86,87,88,32],"Flat Feet","Flexor Tendon Rupture","Tibialis Posterior Dysfunction",[90,91,92,93,94,95,96,97],"human allogeneic cortical bone screw","Shark Screw®","flat foot deformity","FDL Transfer","Tibialis posterior dysfunction","metal screw","Bio-Tenodesis screw","flat foot","2025-03-17",{"date":100,"type":65},"2025-03-20",{"date":102,"type":65},"2022-02-10",{"date":104,"type":20},"2028-02",{"name":106,"class":107},"Orthopedic Hospital Vienna Speising","OTHER"]