Retrospective Study on Clinical Performance and Safety Profile of Agile Nail

Fractures, Bone Clinical Trial

— Agile  

Official title:

Multicenter Retrospective Observational Study to Assess the Clinical Performance and Safety Profile of Agile Nail in Paediatric Patients Who Have Suffered 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: Agile Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412939
• Other study ID #: OCI_2304
• Secondary ID: 335551
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Orthofix s.r.l.
• Contact: Edo Knijff
• Phone: +390456719000
• Email: EdoKnijff[@]orthofix.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

Inclusion Criteria:

1. The patient has been adequately informed by providing the PIS. 1.1 The patient expressed his willingness to participate in the Study by signing and dating informed consent (valid only for UK patients according to local law).

2. Patients who had a regular indication for surgical intervention with Agile Nail according to the manufacturer's IFU.

3. Patients in pediatric age ((> 18 month and < 18 years) at the time of surgery.

4. Patients skeletally immature.

5. Patients who underwent surgery performed with Agile Nail.

6. Patients with clinical data registered in her/him medical records sufficient to assess the safety and efficacy endpoint of the study: in particular, the patient has at least one followup at minimum 3 months from the surgery where is possible for the investigator to assess the consolidation of the treated bone.

7. The patient had surgery at least 1 year before enrollment.

Exclusion Criteria:

1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet.

2. Patient who had/has a concomitant not permitted device which cannot be safely removed.

3. Patient for whom there are other concurrent medical or other conditions that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study.

4. The patient had surgery less than 1 year before enrollment.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Deformity; Bone
• Fractures, Bone
• Impending Fracture

Intervention

Device:
• Agile Nail
Intramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix s.r.l.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After 5 month (approximately) from surgery
Primary	Post-treatment fracture-free survival	The measurement will be used to assess efficacy	up to 1 year
Primary	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	from the date of surgery until the last follow-up, assessed up to 1 year
Primary	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	from the date of surgery until the last follow-up, assessed up to 1 year
Primary	Percentage of procedures who experienced at least one MDDs that caused an effect on the patient	This outcome will be used to measure safety	from the date of surgery until the last follow-up, assessed up to 1 year