Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Recruiting now
Conditions studied: Leg Length Inequality
In brief
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)
Key facts
- Study ID
- NCT06156384
- Run by
- Orthofix s.r.l.
- People needed
- 45
- Starts
- 2024-06-18
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2025-08-28
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- CHU de Saint-Étienne Hôpital Nord — Saint-Etienne, Auvergne-Rhône-Alpes, France (enrolling)
- CHU de Strasbourg — Strasbourg, Grand Est, France (enrolling)
- CHU Lille - Hôpital Jeanne de Flandre — Lille, Hauts-de-France, France (enrolling)
- Centre hospitalier universitaire (CHU) de Toulouse — Toulouse, Occitanie, France (enrolling)
- Hôpital Sainte-Marguerite AP-HM — Marseille, Provence-Alpes-Côte d'Azur Region, France (enrolling)
- CHU de La Réunion site Sud Saint-Pierre — Saint-Pierre, La Réunion, Reunion (enrolling)
Full record on ClinicalTrials.gov
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