NCT06156384

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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)

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 standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice. Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions. Six visits are planned: 1. Surgery (baseline) 2. End of the distraction phase 3. End of bone healing 4. Implant removal 5. 6-month post-removal 6. 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery. The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery. Pain will be assessed at all timepoints. Measurement of pain at the end of the distraction phase, the patient will be requested to report the pain experienced in the past week, at the moment, and during or immediately after the distraction period. At other time points, pain for only at the moment will be captured. Range of motion (ROM) will be measured at the end of bone healing, and at the 24 months post-surgery. Lengthening achieved will be measured at the end of bone healing. Any incidence of adverse events will be recorded at any point during the 24-month follow-up period.

Conditions

• Leg Length Inequality

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-18
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2023-12-05
• Last updated: 2025-08-28

Locations

6 sites across 2 countries: France, Reunion