An observational study in Fractures, Bone, Impending Fracture and Deformity; Bone, sponsored by Orthofix s.r.l.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Orthofix s.r.l. · Observational
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For Use (IFU) in the time frame from the time of surgery until the last follow-up visit available at the hospitals.
The study will be conducted in two investigational sites, one in France and one in United Kingdom, both experienced in the treatment of pediatric patients with femoral shaft and subtrochanteric fractures and deformity correction procedures or have performed prophylactic nailing of impending pathologic fractures, where the usage of AGILE NAIL (known as AGILE) was part of the normal clinical practice.
Investigator of both study sites will provide data for a maximum of 45 patients meeting inclusion and exclusion criteria (Considering a drop-out or a non-evaluable rate of 10% of the procedures) that will contribute for approximately 45 procedures in which AGILE was used.
No diagnostic or therapeutic intervention outside of routine clinical practice will be applied. The study has been designed to analyze medical records of patients where study data was collected as part of their routine clinical practice. Therefore, patients will be retrospectively enrolled in the study. Patients who have undergone AGILE implantation from 04/2018 to 12/2022 are considered for the study. The observation period of study subjects will comprise from surgery until the last follow up visit available.
Medical records of the participating sites are expected to contain all the required information.
In United Kingdom, no study visit will be required but according to local legislation, it will be essential that before collecting any information from medical records, participants or their guardians are asked for specific informed consent to be signed by them before any collection of patient information takes place.
However, in France, due to the use of primary data and the foreseen exemption of the informed consent (IC) form (see Section 14.2 Informed Consent), no study visit will be required.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Orthofix s.r.l. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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The full analysis set includes all paediatric patients who that have been treated for femoral shaft and subtrochanteric fractures or have performed prophylactic nailing of impending pathologic fractures or have undergone fixation of femurs that have been surgically prepared for deformity correction with the Agile nail, that will be systematically consecutive screened at the centers.
Exclusion Criteria:
The full analysis set includes all paediatric patients who that have been treated for femoral shaft and subtrochanteric fractures or have performed prophylactic nailing of impending pathologic fractures or have undergone fixation of femurs that have been surgically prepared for deformity correction with the Agile nail, that will be systematically consecutive screened at the centers.
Device: Agile Nail
Intramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation
Also known as: Rigid intramedullary nail
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit
The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union
Time frame: After 5 month (approximately) from surgery
Post-treatment fracture-free survival
The measurement will be used to assess efficacy
Time frame: up to 1 year
Percentage of procedures in which deformity correction was maintained according to investigator's opinion (only for procedure where the indication is "Deformity Correction")
The measurement will be used to assess efficacy
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
Percentage of procedures with at least one serious/not serious adverse event certainly related or possibly related to Agile Nail (ADEs/SADEs)
This outcome will be used to measure safety
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
Percentage of procedures who experienced at least one MDDs that caused an effect on the patient
This outcome will be used to measure safety
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Orthofix s.r.l.