An observational study in Leg Length Inequality, sponsored by Orthofix s.r.l.. Recruiting at 6 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Orthofix s.r.l. · Observational
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.
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:
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.
30 studies on the registry are indexed under Leg Length Inequality; 2 are open to participants now.
This study's planned enrollment of 45 is below the median of 90 across 11 observational studies indexed under Leg Length Inequality.
Browse Leg Length Inequality studies →Orthofix s.r.l. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged ≥12 years with congenital or acquired lower limb discrepancy, greater than 30mm
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: at 6 months after implant removal date and at 24 months follow-up
Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE
The clinical safety of Fitbone will be measured Collecting and characterizing the complications (expressed as adverse events and device deficiencies) associated with FITBONE that will be assessed by the investigators.
Time frame: from surgery to 24 months follow-up
Effectiveness of Fitbone by limb lengthening
The lengthening goal is considered 'achieved' when, at the end of bone healing, the limb length is within 5 mm of the lengthening objective defined by the investigator when using FITBONE.
Time frame: 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
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".
Time frame: 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
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.
Time frame: from surgery to 24 months follow-up
Describe pain at each visit using 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.
Time frame: from surgery to 24 months follow-up
Describe patients Range Of Motion (ROM in degrees) evolution at end of bone healing and at 24 months after surgery compared to baseline
The knee range of motion will measured in degree Difference in the range of motion through the passive extension before surgery (baseline) to the end of bone healing, and at 24 months post-surgery
Time frame: from surgery to 24 months follow-up
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