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The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with femur fractures | adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimaera Long Nail | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults suffering from pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERATM) was part of the normal clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AORN Sant'Anna e San Sebastiano | Caserta | CE | 81100 | Italy | ||
| Craeggi Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Femur Fractures | adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Femur Fractures | adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep infection | Infections and infestations | Non-systematic Assessment | Deep infection not dependent on nail, but on patient's physical condition. nail removal plus antibiotic therapy still ongoing at end of infection, will need to undergo another procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Orthofix | 0456719077 | danielacangiano@orthofix.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2023 | Jun 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2024 | Jun 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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|
| Florence |
| FI |
| 50134 |
| Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| 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). | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 44 |
| 2 |
| 44 |
| 2 |
| 44 |
|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient underwent reduction and synthesis procedure for femoral shaft fracture with plate and screws plus bank bone stick with cerclage |
|
| Anemia | Surgical and medical procedures | Non-systematic Assessment |
|
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