N/A
N=206
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
Hip Fractures · Subtrochanteric Fractures · Intertrochanteric Fractures · Pertrochanteric Fracture
Bottom Line
View on ClinicalTrials.gov: NCT05197335 ↗Enrolled (actual)
206
Serious AEs
38.4%
Results posted
Jan 2026
Primary outcome: Primary: Percentage of Patients Needing a Second Surgery — 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Orthofix s.r.l.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Needing a Second Surgery |
— | — |
| SECONDARY Functional Score of Bowers & Parker |
4.11; 3.14; 1.73 | — |
Summary
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body. The sponsor has planned to actively collect clinical data relating to the use of Chimaera Intramedullary Nail in a representative number of users and elderly patients with fractures of the proximal femur. The data obtained from this clinical investigation will be used to complete the pre-market clinical evaluation carried out on the Chimaera with post-market clinical data from the use of the device in normal clinical practice.
Eligibility Criteria
Inclusion Criteria
- directly or indirectly (through a respondent) will have expressed their will to participate in the study by signing and dating the informed consent;
- will have reached the age of 65 at the time of signing the informed consent;
- he/she will have been diagnosed with a fracture in the pertrochanteric, intertrochanteric or subtrochanteric region of the femur, stable or unstable, not previously treated;
- based on the investigator's judgment, he will have a regular indication for surgical treatment with an intramedullary nail;
- the fracture will be treated with the Chimaera short nail (length = 180 mm) and one or two telescopic lag screws, according to the manufacturer's instructions for use.
Exclusion Criteria
- will undergo surgery to treat the results of a previously treated fracture;
- he/she will have been diagnosed with a pathological fracture of oncological origin (primary tumor or skeletal metastasis);
- he/she will have been diagnosed with a fracture in the diaphyseal and/or distal region of the femur;
- he/she will have been diagnosed with an open fracture (type II and III according to the classification of Gustilo and Anderson) of the proximal femur;
- he/she will have been diagnosed with multiple fractures (including bilateral proximal femur fractures);
- in the pre-or intra-operative phase it will be decided to treat the fracture with the long version of the Chimaera nail and/or with non-telescopic cephalic screws (fixed length);
- will have a medical condition that constitutes a contraindication to treatment with Chimaera according to the manufacturer's instructions for use;
- will have a suspected or certified hypersensitivity/allergy to some component of the device that comes into contact with the patient;
- will present some clinical condition that, in the Investigator's opinion, could interfere with the procedures of the Clinical Investigation or that could jeopardize the safety of the patient;
- at the same time he will be treated with an unauthorized device that cannot be removed without endangering the safety of the patient;
- will be participating in other clinical trials or had participated in other clinical trials in the 3 months before signing the informed consent.
Data sourced from ClinicalTrials.gov (NCT05197335). 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.