Assessing pain and quality of life in patients using FITBONE lengthening nails
Official title: Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
Run by Orthofix s.r.l. · NCT06156384 · Data updated 2026-11-12
This study looks at how the FITBONE lengthening procedure affects pain and quality of life for patients aged 12 and older with a leg length difference of 30mm or more.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Orthofix s.r.l. Industry-sponsored |
| Locations | 6 sites (Saint-Etienne, Auvergne-Rhône-Alpes and 5 other locations) |
| Status | Recruiting |
| Started | June 18, 2024 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | August 28, 2025 |
| Trial ID | NCT06156384 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 12 years or older with a leg length discrepancy greater than 30mm who are undergoing femoral or tibial lengthening with FITBONE.
✕Probably not a fit
Patients with medical conditions contraindicated for FITBONE use or those likely to be lost to follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates patients aged 12 and older who are undergoing a lower limb lengthening procedure with FITBONE due to a leg length discrepancy of 30mm or more. Over a period of 24 months, the study will assess pain levels, patient satisfaction, and quality of life using various standardized scales. Data will be collected through a standardized case record form after informed consent, with healthcare providers managing patients according to usual clinical practices. The study aims to gather insights into the outcomes associated with the FITBONE lengthening procedure.
Why it matters
Potential benefit: If successful, this study could provide valuable information on pain management and quality of life improvements for patients undergoing limb lengthening procedures.
How similar studies have gone: While this study is observational, similar approaches in assessing patient outcomes in limb lengthening have shown promise, indicating potential for valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, France Recruiting -
CHU de Strasbourg
Strasbourg, Grand Est, France Recruiting -
CHU Lille - Hôpital Jeanne de Flandre
Lille, Hauts-de-France, France Recruiting -
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, Occitanie, France Recruiting -
Hôpital Sainte-Marguerite AP-HM
Marseille, Provence-Alpes-Côte d'Azur Region, France Recruiting -
CHU de La Réunion site Sud Saint-Pierre
Saint-Pierre, La Réunion, Reunion Recruiting
Study contacts
- Principal investigator: Franck Accadbled, Prof. — Centre hospitalier universitaire (CHU) de Toulouse
- Study coordinator: Tommaso Marano
- Email: tommasomarano@orthofix.it
- Phone: +39 0456719000
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.