Retrospective Study on Clinical Performance and Safety Profile of Agile Nail

NCT06412939 | Terminated

• 2 other identifiers: OCI_2304335551
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fractures, Bone; Impending Fracture; Deformity; Bone

Keywords

nail; intramedullary; rigid nail; pediatric

Outcome Measures

Primary Outcomes (5)

• 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

• Post-treatment fracture-free survival

  The measurement will be used to assess efficacy

  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

  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

  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

  from the date of surgery until the last follow-up, assessed up to 1 year

Study Arms (1)

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

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

Interventions

Agile Nail DEVICE

Intramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation

Also known as: Rigid intramedullary nail

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

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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).
• Patients who had a regular indication for surgical intervention with Agile Nail according to the manufacturer's IFU.
• Patients in pediatric age ((\> 18 month and \< 18 years) at the time of surgery.
• Patients skeletally immature.
• Patients who underwent surgery performed with Agile Nail.
• 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.
• The patient had surgery at least 1 year before enrollment.

You may not qualify if:

• Patient who had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet.
• Patient who had/has a concomitant not permitted device which cannot be safely removed.
• 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.
• The patient had surgery less than 1 year before enrollment.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Wounds and Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patrick Foster, MD

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 14, 2024
• Study Start: July 26, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)