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

NCT06156384 | Recruiting

• 2 other identifiers: OCI_23012023-A02702-43
• Study Type: observational
• Target: 45
• Locations: 2 countries
• Sites: 6

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 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

Keywords

Fitbone; LLD; Bone lengthening; Nail; Nailing; Intramedullary nailing; Intramedullary nail; Motorized Nail

Outcome Measures

Primary Outcomes (3)

• Describe Patients' Pain by Visual Analog Scale (VAS)

  Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.

  at 6 months after implant removal date and at 24 months follow-up

• Describe Patients' patient Quality of Life (QoL) using Short Form 36 Health Survey (SF-36) for adult patients and PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale for children patients.

  The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.

  at 6 months after implant removal date and at 24 months follow-up

• Describe Patients' satisfaction

  A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing Very much improved; to 7 being Very much worse.

  at 6 months after implant removal date and at 24 months follow-up

Secondary Outcomes (6)

• Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE

  from surgery to 24 months follow-up

• Effectiveness of Fitbone by limb lengthening

  at the end of bone healing, approximately 6 months

• Assess satisfaction evolution at implant removal , 6 months after Fitbone removal and at 24 months after surgery

  from surgery to 24 months follow-up

• Describe evolution of QoL at 6 months after Fitbone removal and at 24 months after surgery, compared to baseline

  from surgery to 24 months follow-up

• Describe pain at each visit using VAS

  from surgery to 24 months follow-up

Study Arms (1)

Patients

Patients aged ≥12 years with congenital or acquired lower limb discrepancy, greater than 30mm

Device: FITBONE® Lengthening Nail

Interventions

FITBONE® Lengthening Nail DEVICE

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.

Patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The aim of the study is to have a representative population of FITBONE patients in France, who are cimpliant with the inclusion criteria, during the 1 year enrollment period. Any centre in France that uses FITBONE in their routine clinical practice will be invited and have the opportunity to participate in this study. All centres must systematically and without exception offer every patient being implanted with FITBONE the opportunity to participate in the study, limiting selection bias and increasing the representativeness of this study to the French population.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (6)

CHU de Saint-Étienne Hôpital Nord

Saint-Etienne, Auvergne-Rhône-Alpes, 42270, France

RECRUITING

CHU de Strasbourg

Strasbourg, Grand Est, 67091, France

RECRUITING

CHU Lille - Hôpital Jeanne de Flandre

Lille, Hauts-de-France, 59120, France

RECRUITING

Centre hospitalier universitaire (CHU) de Toulouse

Toulouse, Occitanie, 31300, France

RECRUITING

Hôpital Sainte-Marguerite AP-HM

Marseille, Provence-Alpes-Côte d'Azur Region, 13274, France

RECRUITING

CHU de La Réunion site Sud Saint-Pierre

Saint-Pierre, La Réunion, 97448, Reunion

RECRUITING

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Franck Accadbled, Prof.

  Centre hospitalier universitaire (CHU) de Toulouse

  PRINCIPAL INVESTIGATOR

• Maxime Fabre-Aubrespy, MD

  Hôpital Sainte-Marguerite AP-HM

  PRINCIPAL INVESTIGATOR

• Damien Fron, MD

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Ruzic, MD

  CHU de La Réunion site Sud Saint-Pierre

  PRINCIPAL INVESTIGATOR

• Hassan Al Khoury Salem, MD

  CHU de Saint-Étienne Hôpital Nord

  PRINCIPAL INVESTIGATOR

• Ludovic Paul Schneider, MD

  CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Marano

CONTACT

+39 0456719000; tommasomarano@orthofix.it

Daniela Cangiano

CONTACT

+39 0456719000; danielacangiano@orthofix.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 5, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

FR (5); RE (1)