Observational Retrospective Study to Assess the Clinical Benefit and Safety Profile of the Intramedullary Nail CHIMAERA in Adult Patient Who Have Suffered Pertrochanteric, Intertrochanteric and Subtrochanteric Fractures of the Femur in Daily Practice: CHIMAERA Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Percent of Patients in Which Bone Union Has Been Achieved
Study Overview
Brief Summary
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
Detailed Description
The CHIMERA study intends to evaluate the clinical benefits of the study medical/investigational device in the standard clinical practice. The study will be conducted in two sites located in Italy; both considered reference sites for the treatment of adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERA) was part of the normal clinical practice. The CHIMAERA, is an internal fixation system intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch. The participant investigators will retrospectively include a maximum of 44 patients meeting inclusion and exclusion criteria (considering an imprecision of 5%) that will contribute for approximately 44 patients in which CHIMAERA was used.
The study is designed to analyze medical records of adult patients who underwent CHIMAERA implantation from 2018 to 2023 in the standard clinical practice setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 .
Outcomes
Primary Outcomes
Percent of Patients in Which Bone Union Has Been Achieved
Time Frame: 12 months
The clinical benefit of CHIMAERATM will be assessed by the percentage of patients in which bone union has been achieved within 12 months from the nail implant.
Secondary Outcomes
- Percent of Patients That Required a Reoperation(6 months)