Hip FracturesChimaeraNCT05197335
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
An observational study of Hip Fractures and Subtrochanteric Fractures, run by Orthofix s.r.l. at 8 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures
- What is being tested?
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 8 sitesItaly
- Study dates
- 9 Jul 2020to 31 Jul 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: An adult patient with a previously untreated proximal femur fracture who, based on the free judgment of the Investigator, will have a regular indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. Eligible patients who meet the inclusion criteria and no exclusion criteria will be considered eligible for participation in this Clinical Investigation.
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Ospedale Regionale EE 'Miulli'
Acquaviva delle Fonti, BA, 70021
A.O. Sant'Anna e San Sebastiano Caserta
Caserta, CE, 81100
A.O.U. Policlinico - Vittorio Emanuele
Catania, CT, 95123
Ospedale S. Giuseppe
Empoli, FI, 50053
Az. Ospedaliero - Universitaria Careggi
Florence, FI, 50134
ASST di Mantova, Osp. Carlo Poma
Mantua, MN, 46100
Nuovo Ospedale di Prato S. Stefano
Prato, PO, 59100
Ospedale di Vicenza
Vicenza, VI, 36100
About this study
Official title: Observational, Prospective and Multicentre Clinical Study for the Evaluation of Clinical Parameters of Elderly Patients With Fractures of the Proximal Femur Treated by the Intramedullary Nail Chimaera (Orthofix Srl) Italian on Documents: Indagine Clinica Osservazionale, Prospettica e Multicentrica Per la Valutazione di Parametri Clinici di Pazienti Anziani Con Frattura Del Femore Prossimale Trattata Mediante il Chiodo Intramidollare Chimaera (Orthofix Srl)
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.
Read the detailed description
Orthofix Srl has developed and placed on the European market the Chimaera Intramedullary Nail after having evaluated the clinical performance and safety of the medical device based on biomechanical tests and clinical data obtained from scientific publications on equivalent products. The outcome of this pre-market assessment established that Chimaera possesses the requirements for CE marking, in particular, it possesses an acceptable risk/benefit ratio if used according to the manufacturer's directions for use.
The enrolled patients, as would happen even if they did not decide to participate in this study, will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
After the surgery and the hospital discharge, the patient will undergo subsequent follow-up visits. The follow-up visits carried out respectively at 1 month and 3 months after the date of surgery, conclude the treatment period which, barring complications, is expected within 8 - 12 weeks from the date of surgery with the consolidation of the fracture of the proximal femur treated. Healing will be verified by the Investigator based on an X-ray check through which he/she will make a qualitative assessment of the bone density at the fracture site and the positioning of the bone stumps. Starting from the 3-month visit and up to 1-year visit, the Investigator will compile the Bowers \& Parker functional score (a measure of effectiveness) for the evaluation of the patient's functional recovery. The score obtained at the follow-up visits will be compared to the score compiled during the discharge visit representative of the pre-fracture patient's status.
For patients that undergo this treatment, the removal of the device is not planned except for serious adverse events that require a second surgery to complete the treatment of the fracture (safety measure). Once the treatment period has ended, the control period begins during which 2 visits will be made, respectively 6 months and 1 year after the date of the surgery. During these visits, clinical data will be collected to follow the evolution of the fracture consolidation and the functional recovery of the patient and the occurrence of any adverse events in the medium term.
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Being tested
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Keywords
- Femur, Fracture, Femoral, Nail, Nailing, Trochanteric, Sliding, Screw, Intramedullary, Elderly Patients
- 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 short nail (length = 180 mm) in combination with one or two telescopic cephalic screwsDevice
The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Age of 65 at the time of signing the informed consent. Receives: Device: Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Needing a Second Surgery
Safety measurement outcome: the percentage of patients who, due to serious adverse events related to Chimaera, will have to undergo a second surgery to continue with the treatment of the proximal femur fracture.
Measured: 6 months
Secondary outcomes (1)
Functional Score of Bowers & Parker
Efficacy measurement outcome: the functional score of Bowers \& Parker for the evaluation of the functional recovery of the patient. This score is made of three continuous scales defined for pain, mobility and functional independence. The Pain score is assessed from 0 (Unable to answer) to 8 (Constant and severe pain in the hip requiring regular strong analgesia such as opiates). The Mobility score is assessed from 1 (Never uses any walking aid and no restriction in walking distance) to 10 (Bedbound most or all of the day). The Functional score is assessed from 1 (Completely independent. Requires no assistance in basic or advanced activities of daily living (ADL) including shopping) to 8 (Patient temporarily resident in hospital requiring both nursing and medial care).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start9 Jul 2020
- Primary completion31 Mar 2022
- Study completion31 Jul 2022
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Prospective
- Enrolment
- 206 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
- NCT05197335
- Sponsor's protocol ID
- OCI_1901
- Acronym
- Chimaera
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2021
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Close JD, Swartz K, Deu R. Hip fracture in older patients: tips and tools to speed recovery. J Fam Pract. 2013 Sep;62(9):484-92.
PubMed 24080557Sheehan SE, Shyu JY, Weaver MJ, Sodickson AD, Khurana B. Proximal Femoral Fractures: What the Orthopedic Surgeon Wants to Know. Radiographics. 2015 Sep-Oct;35(5):1563-84. doi: 10.1148/rg.2015140301. Epub 2015 Jul 17.
PubMed 26186669Innocenti M, Civinini R, Carulli C, Matassi F. Proximal femural fractures: epidemiology. Clin Cases Miner Bone Metab. 2009 May;6(2):117-9.
PubMed 22461159Orive M, Aguirre U, Garcia-Gutierrez S, Las Hayas C, Bilbao A, Gonzalez N, Zabala J, Navarro G, Quintana JM. Changes in health-related quality of life and activities of daily living after hip fracture because of a fall in elderly patients: a prospective cohort study. Int J Clin Pract. 2015 Apr;69(4):491-500. doi: 10.1111/ijcp.12527. Epub 2015 Feb 27.
PubMed 25721490Sciard D, Cattano D, Hussain M, Rosenstein A. Perioperative management of proximal hip fractures in the elderly: the surgeon and the anesthesiologist. Minerva Anestesiol. 2011 Jul;77(7):715-22. Epub 2011 Feb 1.
PubMed 21283071Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.
PubMed 25662415Bowers TM, Parker MJ. Assessment of outcome after hip fracture: development of a universal assessment system for hip fractures. SICOT J. 2016;2:27. doi: 10.1051/sicotj/2016018. Epub 2016 Jun 3.
PubMed 27259572
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective and Multicentre Clinical Study for the Evaluation of Clinical Parameters of Elderly Patients With Fractures of the Proximal Femur Treated by the Intramedullary Nail Chimaera (Orthofix Srl) Italian on Documents: Indagine Clinica Osservazionale, Prospettica e Multicentrica Per la Valutazione di Parametri Clinici di Pazienti Anziani Con Frattura Del Femore Prossimale Trattata Mediante il Chiodo Intramidollare Chimaera (Orthofix Srl)
- ClinicalTrials.gov ID
- NCT05197335
- Acronym / sponsor ID
- Chimaera / OCI_1901
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Keywords
- Femur, Fracture, Femoral, Nail, Nailing, Trochanteric, Sliding, Screw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 20 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Orthofix Srl has developed and placed on the European market the Chimaera Intramedullary Nail after having evaluated the clinical performance and safety of the medical device based on biomechanical tests and clinical data obtained from scientific publications on equivalent products. The outcome of this pre-market assessment established that Chimaera possesses the requirements for CE marking, in particular, it possesses an acceptable risk/benefit ratio if used according to the manufacturer's directions for use.
The enrolled patients, as would happen even if they did not decide to participate in this study, will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
After the surgery and the hospital discharge, the patient will undergo subsequent follow-up visits. The follow-up visits carried out respectively at 1 month and 3 months after the date of surgery, conclude the treatment period which, barring complications, is expected within 8 - 12 weeks from the date of surgery with the consolidation of the fracture of the proximal femur treated. Healing will be verified by the Investigator based on an X-ray check through which he/she will make a qualitative assessment of the bone density at the fracture site and the positioning of the bone stumps. Starting from the 3-month visit and up to 1-year visit, the Investigator will compile the Bowers \& Parker functional score (a measure of effectiveness) for the evaluation of the patient's functional recovery. The score obtained at the follow-up visits will be compared to the score compiled during the discharge visit representative of the pre-fracture patient's status.
For patients that undergo this treatment, the removal of the device is not planned except for serious adverse events that require a second surgery to complete the treatment of the fracture (safety measure). Once the treatment period has ended, the control period begins during which 2 visits will be made, respectively 6 months and 1 year after the date of the surgery. During these visits, clinical data will be collected to follow the evolution of the fracture consolidation and the functional recovery of the patient and the occurrence of any adverse events in the medium term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screwsAge of 65 at the time of signing the informed consent. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- An adult patient with a previously untreated proximal femur fracture who, based on the free judgment of the Investigator, will have a regular indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. Eligible patients who meet the inclusion criteria and no exclusion criteria will be considered eligible for participation in this Clinical Investigation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
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 short nail (length = 180 mm) in combination with one or two telescopic cephalic screwsThe enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period. | Device | Study Group |
Primary outcome
Percentage of Patients Needing a Second Surgery
Time frame: 6 months
Safety measurement outcome: the percentage of patients who, due to serious adverse events related to Chimaera, will have to undergo a second surgery to continue with the treatment of the proximal femur fracture.
1 secondary outcome
Functional Score of Bowers & Parker
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24080557Close JD, Swartz K, Deu R. Hip fracture in older patients: tips and tools to speed recovery. J Fam Pract. 2013 Sep;62(9):484-92.
- Background: PubMed 26186669Sheehan SE, Shyu JY, Weaver MJ, Sodickson AD, Khurana B. Proximal Femoral Fractures: What the Orthopedic Surgeon Wants to Know. Radiographics. 2015 Sep-Oct;35(5):1563-84. doi: 10.1148/rg.2015140301. Epub 2015 Jul 17.
- Background: PubMed 22461159Innocenti M, Civinini R, Carulli C, Matassi F. Proximal femural fractures: epidemiology. Clin Cases Miner Bone Metab. 2009 May;6(2):117-9.
- Background: PubMed 25721490Orive M, Aguirre U, Garcia-Gutierrez S, Las Hayas C, Bilbao A, Gonzalez N, Zabala J, Navarro G, Quintana JM. Changes in health-related quality of life and activities of daily living after hip fracture because of a fall in elderly patients: a prospective cohort study. Int J Clin Pract. 2015 Apr;69(4):491-500. doi: 10.1111/ijcp.12527. Epub 2015 Feb 27.
- Background: PubMed 21283071Sciard D, Cattano D, Hussain M, Rosenstein A. Perioperative management of proximal hip fractures in the elderly: the surgeon and the anesthesiologist. Minerva Anestesiol. 2011 Jul;77(7):715-22. Epub 2011 Feb 1.
- Background: PubMed 25662415Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.
- Background: PubMed 27259572Bowers TM, Parker MJ. Assessment of outcome after hip fracture: development of a universal assessment system for hip fractures. SICOT J. 2016;2:27. doi: 10.1051/sicotj/2016018. Epub 2016 Jun 3.
- ICJME. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Subtrochanteric Fractures, run by Orthofix s.r.l. at 8 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 11 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 20 Jan 2026). 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?
Percentage of Patients Needing a Second Surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197335, which also lists 7 linked publications.
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 20 Jan 2026.