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

Recruitingn/aAges 12 Years - anyAllOrthofix s.r.l.
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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). * Patients participating in other clinical or have taken part in any clinical study in the last 3 months.
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What it tests

  • FITBONE® Lengthening Nail
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Where

6 sites
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, France
CHU de Strasbourg
Strasbourg, France
CHU Lille - Hôpital Jeanne de Flandre
Lille, France
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, France
Hôpital Sainte-Marguerite AP-HM
Marseille, France
CHU de La Réunion site Sud Saint-Pierre
Saint-Pierre, Reunion
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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