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

NCT06156384 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-08-28

No results posted yet for this study

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)

Conditions

  • Leg Length Inequality

Interventions

DEVICE

FITBONE® Lengthening Nail

The patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter. After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation.

Sponsors & Collaborators

  • Orthofix s.r.l.

    lead INDUSTRY

Principal Investigators

  • Franck Accadbled, Prof. · Centre hospitalier universitaire (CHU) de Toulouse

  • Maxime Fabre-Aubrespy, MD · Hôpital Sainte-Marguerite AP-HM

  • Damien Fron, MD · CHU Lille

  • Jean-Christophe Ruzic, MD · CHU de La Réunion site Sud Saint-Pierre

  • Hassan Al Khoury Salem, MD · CHU de Saint-Étienne Hôpital Nord

  • Ludovic Paul Schneider, MD · CHU de Strasbourg

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • France
  • Reunion

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156384 on ClinicalTrials.gov