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Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Sponsor: Orthofix s.r.l.
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)
Official title: Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
45
Start Date
2024-06-18
Completion Date
2029-06-30
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
FITBONE® Lengthening Nail
The patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter. After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation.
Locations (6)
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, France
CHU de Strasbourg
Strasbourg, Grand Est, France
CHU Lille - Hôpital Jeanne de Flandre
Lille, Hauts-de-France, France
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, Occitanie, France
Hôpital Sainte-Marguerite AP-HM
Marseille, Provence-Alpes-Côte d'Azur Region, France
CHU de La Réunion site Sud Saint-Pierre
Saint-Pierre, La Réunion, Reunion