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)
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
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).
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.
Cohort
Prospective
FITBONE® Lengthening Nail
DeviceThe 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.
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.
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.
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.
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.
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".
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.
Click on the lead sponsor to view all of their trials.
