[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orthofix s.r.l.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100599075","truelok-elevate-pmcf-study-100599075",false,"NCT07079774","TrueLok Elevate PMCF Study","Post-Market Clinical Follow-up Study of the TrueLok Elevate Transverse Bone Transport System for the Treatment of Lower Limb Ulcers as Soft Tissue Defects","Inclusion Criteria:\n\nAged 18 years or older at the time of surgery Willing and able to sign and date the study-specific informed consent form in accordance with national and institutional ethics requirements Willing and able to comply with requirements of the protocol, including follow-up requirements Indicated for surgical intervention using the TrueLok Elevate Transverse Bone Transport System for the treatment of soft tissue defects in the form of lower limb ulcers\n\nPresence of a chronic ulcer, defined as:\n\n* Present for at least 3 months, and\n* Unresponsive to standard non-surgical or surgical wound management, including but not limited to debridement, negative pressure wound therapy (VAC), offloading, antibiotics, or vascular optimisation\n\nExclusion Criteria:\n\nMental or cognitive impairment or physiological or behavioural conditions that, in the opinion of the investigator, would preclude reliable adherence to postoperative care instructions, follow-up assessments, or study procedures\n\nKnown or presenting with the following signs of a systemic inflammatory response syndrome (SIRS) as exhibiting two or more of the following conditions:\n\no\n\n* Heart rate \\>90 beats\u002Fmin\n* Respiratory rate \\>20 breaths\u002Fmin\n* PaCO2 \\\u003C32-mm Hg\n* White blood cell count \\>12.000 or \\\u003C4.000\u002Fcu mm\n* 10% immature (band) forms Known hypersensitivity or allergy to any material used in the TrueLok Elevate Transverse Bone Transport System (e.g., stainless steel, titanium) Current participation in another interventional clinical study that, in the opinion of the investigator, may interfere with the objectives or outcomes of this study Presence of active malignancy or systemic infection that, in the investigator's opinion, may interfere with wound healing or the study protocol Life expectancy of less than 12 months Simultaneous bilateral application of the TrueLok Elevate Transverse Bone Transport System Current incarceration at the time of enrolment Any condition or clinical circumstance that, in the opinion of the investigator, would make participation not in the best interest of the subject or would interfere with the study objectives","ALL","18 Years",{"count":19,"type":20},153,"ESTIMATED","OBSERVATIONAL","The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport. It promotes local vascular and wound healing through controlled corticotomy and gradual distraction. The system is intended for adult patients with bony and\u002For soft tissuedefects.",[24,25,26],"Wound of Skin","Ulcers","Soft Tissue Defect","RECRUITING","2026-03-31",{"date":30,"type":31},"2026-04-01","ACTUAL",{"date":33,"type":31},"2025-11-24",{"date":35,"type":20},"2028-11-24",{"name":37,"class":38},"Orthofix s.r.l.","INDUSTRY",5,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100528101","study-to-assess-the-pain-satisfaction-and-quality-of-life-of-patients-with-fitbone-lengthening-nail-100528101","NCT06156384","Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail","Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail","FitForFrance","Inclusion Criteria:\n\n* Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE\n* Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU\n* The patient (or his\u002Fher legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)\n* The informed consent form is correctly obtained\n\nExclusion Criteria:\n\n* Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.\n* Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.\n* Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.\n* Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).\n* Patients participating in other clinical or have taken part in any clinical study in the last 3 months.","12 Years",{"count":50,"type":20},45,"This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.\n\nThe following parameters will be assessed for up to 24 months.\n\n* Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)\n* Patient satisfaction using the Patient Global Impression of change (PGI-C) scale\n* QoL using the 36-Item Short Form Survey\u002FPaediatric Quality of Life Inventory (SF-36\u002FPedsQL)",[53],"Leg Length Inequality",[55,56,57,58,59,60,61,62],"Fitbone","LLD","Bone lengthening","Nail","Nailing","Intramedullary nailing","Intramedullary nail","Motorized Nail","2025-08-27",{"date":65,"type":31},"2025-08-28",{"date":67,"type":31},"2024-06-18",{"date":69,"type":20},"2029-06-30",{"name":37,"class":38},6,""]