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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Lille - Hôpital Jeanne de Flandre
RECRUITING
Lille
Hôpital Sainte-Marguerite AP-HM
RECRUITING
Marseille
CHU de Saint-Étienne Hôpital Nord
RECRUITING
Saint-etienne
CHU de Strasbourg
RECRUITING
Strasbourg
Centre hospitalier universitaire (CHU) de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Tommaso Marano
tommasomarano@orthofix.it
+39 0456719000
Backup
Daniela Cangiano
danielacangiano@orthofix.it
+39 0456719000
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 45
Treatments
Patients
Patients aged ≥12 years with congenital or acquired lower limb discrepancy, greater than 30mm
Related Therapeutic Areas
Sponsors
Leads: Orthofix s.r.l.

This content was sourced from clinicaltrials.gov