## Protocol Section
### Identification Module
**NCT ID:** NCT06412939

**Acronym:** Agile

**Brief Title:** Retrospective Study on Clinical Performance and Safety Profile of Agile Nail

**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

#### Organization Study ID Info
**ID:** OCI_2304
#### Organization
**Class:** INDUSTRY
**Full Name:** Orthofix s.r.l.
#### Secondary ID Infos
**Domain:** IRAS project ID (UK)
**ID:** 335551
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Orthofix s.r.l.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Fractures, Bone

- Impending Fracture

- Deformity; Bone

**Keywords:**

- nail

- intramedullary

- rigid nail

- pediatric

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Agile Nail

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

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

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

**Name:** Agile Nail

**Other Names:**

- Rigid intramedullary nail

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The measurement of efficacy will be mande with the percentage of procedures that have achieved bone union

**Measure:** Percentage of procedures that have achieved bone union at the "bone consolidation assessment" visit

**Time Frame:** After 5 month (approximately) from surgery

**Description:** The measurement will be used to assess efficacy

**Measure:** Post-treatment fracture-free survival

**Time Frame:** up to 1 year

**Description:** The measurement will be used to assess efficacy

**Measure:** 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

**Description:** This outcome will be used to measure safety

**Measure:** 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

**Description:** This outcome will be used to measure safety

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 18 Years

**Minimum Age:** 18 Months

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** EdoKnijff@orthofix.it

**Name:** Edo Knijff

**Phone:** +390456719000

**Role:** CONTACT

**Contact 2:**

**Name:** Tommaso Marano

**Phone:** +390456719000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Leeds

**Contacts:**

***Contact 1:***

- **Email:** patrick.foster@nhs.net

- **Name:** Patrick Foster, MD

- **Phone:** +4401132432799

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Leeds Teaching Hospitals NHS Trust

**Zip:** LS9 7TF

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M12

- Name: Congenital Abnormalities

- Relevance: HIGH

- As Found: Deformity

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M8719

- Name: Fractures, Spontaneous

- Relevance: LOW

- As Found: Unknown

- ID: M12084

- Name: Muscle Rigidity

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000050723

- Term: Fractures, Bone

### Misc Info Module

- Version Holder: 2024-05-31
