FITBONE System for Bone Lengthening Safety and Performance

Study start date: November 19, 2024

Inclusion Criteria: 1. ≥ 18 years old 2. Expressed willingness to participate in the study by signing and dating the informed consent form 3. Has a segmental bone defect, or limb length defect of at least 2 mm up to ≤ 120 mm, considered suitable for correction with an intramedullary lengthening nail, as confirmed by radiographs. Exclusion Criteria: 1. Conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease, or evidence of inadequate vascularity 2. Poor bone quality that would prevent adequate fixation of the device 3. Compromised capacity for healing 4. Metal allergies and sensitivities 5. Patients in which the implant would cross open, healthy epiphyseal growth plates 6. Insufficient intramedullary space which would lead to cortical weakening or vascular damage during implantation 7. Body weight of \> 100 kg 8. No free access for proximal insertion of the intramedullary transport and lengthening nail (e.g., coxa valga) 9. No reliable exclusion of bone infection 10. Expected non-compliance, mentally ill patient or patient with clouded consciousness 11. Pregnancy 12. Pre-existing nerve palsies 13. Bone defect larger than 120 mm 14. Gustilo Open Fracture Classification Grade IIIB or IIIC