Clinical Trial

Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail

Study acronym: FitForFrance
Recruiting
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Summary
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. The following parameters will be assessed for up to 24 months. * Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA) * Patient satisfaction using the Patient Global Impression of change (PGI-C) scale * QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-12-04; most recent amendment 2025-08-27.
Status change: Not Yet Recruiting → Recruiting 2024-06-20
Trial Details
NCT Number NCT06156384
Lead Sponsor Orthofix s.r.l.
Conditions Leg Length Inequality
Enrollment 45 participants
Start Date 2024-06-18
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-28