Assessing pain and quality of life in patients using FITBONE lengthening nails
Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
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 |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Orthofix s.r.l. Industry-sponsored |
| Locations | 6 sites (Saint-Etienne, Auvergne-Rhône-Alpes and 5 other locations) |
| Trial ID | NCT06156384 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this study is observational, similar approaches in assessing patient outcomes in limb lengthening have shown promise, indicating potential for valuable insights.
Eligibility criteria
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 this trial is running
Saint-Etienne, Auvergne-Rhône-Alpes and 5 other locations
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.