Actively Recruiting
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Led by Orthofix s.r.l. · Updated on 2025-08-28
45
Participants Needed
6
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older with congenital or acquired lower limb discrepancy greater than 30mm undergoing femoral or tibia bone lengthening with FITBONE
- Patients with a regular indication for surgical intervention with FITBONE according to manufacturer instructions
- Patient or legally acceptable representative can understand the informed consent form
- Informed consent form is correctly obtained
You will not qualify if you...
- Patients with medical conditions contraindicated according to FITBONE instructions for use
- Patients with conditions that may interfere with study execution or likely to be lost to follow-up as judged by the investigator
- Patients with medical conditions posing safety concerns or interfering with study participation as judged by the investigator
- Patients requiring or having concomitant devices that cannot be safely removed (except permitted devices)
- Patients participating in or having participated in another clinical study within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42270
Actively Recruiting
2
CHU de Strasbourg
Strasbourg, Grand Est, France, 67091
Actively Recruiting
3
CHU Lille - Hôpital Jeanne de Flandre
Lille, Hauts-de-France, France, 59120
Actively Recruiting
4
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, Occitanie, France, 31300
Actively Recruiting
5
Hôpital Sainte-Marguerite AP-HM
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13274
Actively Recruiting
6
CHU de La Réunion site Sud Saint-Pierre
Saint-Pierre, La Réunion, Reunion, 97448
Actively Recruiting
Research Team
T
Tommaso Marano
CONTACT
D
Daniela Cangiano
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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