N/A
N=44
Retrospective Study Chimaera Long Nail in Adult Patient
Pertrochanteric Fracture of Femur · Intertrochanteric Fracture of Femur · Subtrochanteric Fracture of Femur
Bottom Line
View on ClinicalTrials.gov: NCT06285981 ↗Enrolled (actual)
44
Serious AEs
4.6%
Results posted
Aug 2025
Primary outcome: Primary: Percent of Patients in Which Bone Union Has Been Achieved — 42 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Chimaera Long Nail (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orthofix s.r.l.
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients in Which Bone Union Has Been Achieved |
42 | — |
| SECONDARY Percent of Patients That Required a Reoperation |
— | — |
Summary
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
Eligibility Criteria
Inclusion Criteria
- The patient expressed his willingness to participate in the Study by signing and dating informed consent.
- Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
- Patients equal or older than 18 years at the time of surgery.
- Patients who underwent surgery performed with CHIMAERATM.
- Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.
Exclusion Criteria
- Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
- Patient has been diagnosed with bilateral proximal femur fractures.
- Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
- Patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study.
- The patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior signing the informed consent .
Data sourced from ClinicalTrials.gov (NCT06285981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.