Intertrochanteric Fracture of Femur, Pertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
Conditions
Keywords
intramedullary nail, chimaera, orthofix, fractures, femur
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.
Interventions
DEVICEChimaera Long Nail
The CHIMAERATM, is an internal fixation system intended 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.
Sponsors
Orthofix s.r.l.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient expressed his willingness to participate in the Study by signing and dating informed consent. 2. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU. 3. Patients equal or older than 18 years at the time of surgery. 4. Patients who underwent surgery performed with CHIMAERATM. 5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.
Exclusion criteria
1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet. 2. Patient has been diagnosed with bilateral proximal femur fractures. 3. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed. 4. 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. 5. 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients in Which Bone Union Has Been Achieved | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients That Required a Reoperation | 6 months | The safety profile of CHIMAERATM will be assessed through the percentage of patients that required a reoperation (i.e., additional surgery). |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Femur Fractures adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Chimaera Long Nail: The CHIMAERATM, is an internal fixation system intended 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. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Patients With Femur Fractures |
|---|---|
| Age, Customized Age | 74 years STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 2 / 44 |
| serious Total, serious adverse events | 2 / 44 |
Outcome results
Primary
Percent of Patients in Which Bone Union Has Been Achieved
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.
Time frame: 12 months
Population: Only 42 out of 44 enrolled patient were analysed for the performance endpoint because Two patients did not meet the CIP criteria for the primary endpoint evaluation and were not included in the efficacy analysis of clinical benefit, but were included in study evaluation for safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Femur Fractures | Percent of Patients in Which Bone Union Has Been Achieved | 42 Participants |
Secondary
Percent of Patients That Required a Reoperation
The safety profile of CHIMAERATM will be assessed through the percentage of patients that required a reoperation (i.e., additional surgery).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Femur Fractures | Percent of Patients That Required a Reoperation | 0 Participants |