About this trial
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)
Eligibility criteria
Qualifiers
Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)
The informed consent form is correctly obtained
Disqualifiers
Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.
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.
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.
Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).
Trial design
Treatments tested in this trial
- FITBONE® Lengthening Nail