Fractures, BoneAgileNCT06412939
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
An observational study of Fractures, Bone and Impending Fracture, run by Orthofix s.r.l. at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Fractures, Bone, Impending Fracture, Deformity; Bone
- What is being tested?
- Agile Nail
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2024to 26 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Being tested
- Agile Nail
- Keywords
- nail, intramedullary, rigid nail, pediatric
- Medical subject headings
- Fractures, Bone, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agile NailDevice
Also called Rigid intramedullary nail
Intramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Agile Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 5 month (approximately) from surgery
Post-treatment fracture-free survival
The measurement will be used to assess efficacy
Measured: 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
Measured: 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
Measured: 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
Measured: from the date of surgery until the last follow-up, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start26 Jul 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Why it stopped: This observational, retrospective study was discontinued as part of a strategic decision to reallocate resources to new product development. All patients had completed treatment before the study start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Foster, MD, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412939
- Sponsor's protocol ID
- OCI_2304
- Other IDs
- 335551
- Acronym
- Agile
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06412939
- Acronym / sponsor ID
- Agile / OCI_2304
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Keywords
- nail, intramedullary, rigid nail, pediatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This observational, retrospective study was discontinued as part of a strategic decision to reallocate resources to new product development. All patients had completed treatment before the study start.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in pediatric age (> 18 month and < 18 years) at the time of surgery | – | Device: Agile NailThe 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. |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agile NailAlso: Rigid intramedullary nailIntramedullary implantation of the Agile intramedullary rigid nail in femur to provide bone fixation | Device | Patients in pediatric age (> 18 month and < 18 years) at the time of surgery |
Primary outcome
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit
Time frame: After 5 month (approximately) from surgery
The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union
Post-treatment fracture-free survival
Time frame: up to 1 year
The measurement will be used to assess efficacy
Percentage of procedures in which deformity correction was maintained according to investigator's opinion (only for procedure where the indication is "Deformity Correction")
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
The measurement will be used to assess efficacy
Percentage of procedures with at least one serious/not serious adverse event certainly related or possibly related to Agile Nail (ADEs/SADEs)
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
This outcome will be used to measure safety
Percentage of procedures who experienced at least one MDDs that caused an effect on the patient
Time frame: from the date of surgery until the last follow-up, assessed up to 1 year
This outcome will be used to measure safety
Results and safety
The study was stopped early (reason given: This observational, retrospective study was discontinued as part of a strategic decision to reallocate resources to new product development. All patients had completed treatment before the study start.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Foster, MD principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Impending Fracture, run by Orthofix s.r.l. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This observational, retrospective study was discontinued as part of a strategic decision to reallocate resources to new product development. All patients had completed treatment before the study start.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit (time frame: After 5 month (approximately) from surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.