Pertrochanteric Fracture of FemurNCT06285981
Retrospective Study Chimaera Long Nail in Adult Patient
An observational study of Pertrochanteric Fracture of Femur and Intertrochanteric Fracture of Femur, run by Orthofix s.r.l. at 2 sites in Italy.
Trial summary
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
- What is being tested?
- Chimaera Long Nail
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Nov 2023to 18 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
AORN Sant'Anna e San Sebastiano
Caserta, CE, 81100
Craeggi Hospital
Florence, FI, 50134
About this study
Official title: 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
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
Read the 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.
- Conditions
- Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
- Being tested
- Chimaera Long Nail
- Keywords
- intramedullary nail, chimaera, orthofix, fractures, femur
- Medical subject headings
- Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimaera Long NailDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with femur fractures | adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur Receives: Device: Chimaera Long Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start27 Nov 2023
- Primary completion17 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pertrochanteric Fracture of FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285981
- Sponsor's protocol ID
- OCI_2206
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2024
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06285981
- Acronym / sponsor ID
- OCI_2206
- Conditions
- Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
- Keywords
- intramedullary nail, chimaera, orthofix, fractures, femur
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with femur fractures | – | Device: Chimaera Long Nailadult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimaera Long NailThe 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. | Device | patients with femur fractures |
Primary outcome
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.
1 secondary outcome
Percent of Patients That Required a Reoperation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertrochanteric Fracture of Femur and Intertrochanteric Fracture of Femur, run by Orthofix s.r.l. at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients in Which Bone Union Has Been Achieved (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.