Fractures, Bone Clinical Trial
— AgileOfficial 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
Verified date | May 2024 |
Source | Orthofix s.r.l. |
Contact | Edo Knijff |
Phone | +390456719000 |
EdoKnijff[@]orthofix.it | |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
Orthofix s.r.l. |
United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A | |
Completed |
NCT03506958 -
Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
|
||
Completed |
NCT04426981 -
Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
|
N/A | |
Recruiting |
NCT04389749 -
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
|
N/A | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
Recruiting |
NCT05594199 -
Feasibility of a Virtual Smoking Cessation Program
|
N/A | |
Completed |
NCT04514601 -
A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
|
||
Completed |
NCT05138640 -
Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
|
||
Completed |
NCT02272972 -
Performance Improvement Program on Imaging II
|
||
Completed |
NCT04215315 -
Fracture In Preterm Infants Study (FIPIN Study)
|
||
Completed |
NCT03219125 -
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
|
||
Completed |
NCT04151732 -
Factors Associated With Future Fractures in Middle-aged Men and Women
|
||
Terminated |
NCT05655130 -
Distal Radius Steroid
|
Phase 1 | |
Completed |
NCT02714257 -
Working to Increase Stability Through Exercise
|
N/A | |
Completed |
NCT02428244 -
Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients
|
N/A | |
Recruiting |
NCT04501510 -
Ultrasonography in Fracture Management
|
||
Completed |
NCT03852095 -
Single Time Management Diseases in Pediatric Traumatology
|
||
Completed |
NCT04440631 -
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
|
||
Completed |
NCT03370900 -
Learning Retention in Radiograph Interpretation
|
N/A |