Status:
RECRUITING
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Lead Sponsor:
Orthofix s.r.l.
Conditions:
Leg Length Inequality
Eligibility:
All Genders
12+ years
Brief 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 ...
Detailed Description
The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06156384
Start Date
June 18 2024
End Date
June 30 2029
Last Update
August 28 2025
Active Locations (6)
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1
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42270
2
CHU de Strasbourg
Strasbourg, Grand Est, France, 67091
3
CHU Lille - Hôpital Jeanne de Flandre
Lille, Hauts-de-France, France, 59120
4
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, Occitanie, France, 31300