[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leg-length-inequality\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leg-length-inequality":25},{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100528101","study-to-assess-the-pain-satisfaction-and-quality-of-life-of-patients-with-fitbone-lengthening-nail-100528101",false,"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.","ALL","12 Years",{"count":20,"type":21},45,"ESTIMATED","OBSERVATIONAL","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)",[25],"Leg Length Inequality",[27,28,29,30,31,32,33,34],"Fitbone","LLD","Bone lengthening","Nail","Nailing","Intramedullary nailing","Intramedullary nail","Motorized Nail","RECRUITING","2025-08-27",{"date":38,"type":39},"2025-08-28","ACTUAL",{"date":41,"type":39},"2024-06-18",{"date":43,"type":21},"2029-06-30",{"name":45,"class":46},"Orthofix s.r.l.","INDUSTRY",6]