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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Age of 65 at the time of signing the informed consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale EE 'Miulli' | Acquaviva delle Fonti | BA | 70021 | Italy | ||
| A.O. Sant'Anna e San Sebastiano Caserta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24080557 | Background | 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. | |
| 26186669 | Background | Sheehan 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. |
| Label | URL |
|---|---|
| ICJME. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Age of 65 at the time of signing the informed consent. Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2019 |
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|
| 12 months |
| Caserta |
| CE |
| 81100 |
| Italy |
| A.O.U. Policlinico - Vittorio Emanuele | Catania | CT | 95123 | Italy |
| Ospedale S. Giuseppe | Empoli | FI | 50053 | Italy |
| Az. Ospedaliero - Universitaria Careggi | Florence | FI | 50134 | Italy |
| ASST di Mantova, Osp. Carlo Poma | Mantua | MN | 46100 | Italy |
| Nuovo Ospedale di Prato S. Stefano | Prato | PO | 59100 | Italy |
| Ospedale di Vicenza | Vicenza | VI | 36100 | Italy |
| 22461159 | Background | Innocenti M, Civinini R, Carulli C, Matassi F. Proximal femural fractures: epidemiology. Clin Cases Miner Bone Metab. 2009 May;6(2):117-9. |
| 25721490 | Background | Orive 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. |
| 21283071 | Background | Sciard 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. |
| 25662415 | Background | Prestmo 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. |
| 27259572 | Background | Bowers 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Age of 65 at the time of signing the informed consent. Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 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. | Adult patients with a previously untreated proximal femur fracture who, in the Investigator's sole judgment, has a standard indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. Eligible patients who meet the following inclusion criteria and none of the exclusion criteria will be considered suitable for participation in this Clinical Investigation. | Posted | Count of Participants | Participants | 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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). | Adult patients with a previously untreated proximal femur fracture who, in the Investigator's sole judgment, has a standard indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. We report the Bowers & Parker functional score results at one year after surgery (Visit 6), based on data from 129 patients who completed the assessment at this time point. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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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 | Study Group | Age of 65 at the time of signing the informed consent. Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: 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. | 28 | 206 | 79 | 206 | 23 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative anemia | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Multiple fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fracture and Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Disease complication and Peripheral oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Non-systematic Assessment |
| ||
| Klebsiella infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Supraventricular extrasystoles | Cardiac disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
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| Delirium | Nervous system disorders | Non-systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Marasmus | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Metabolic alkalosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Red blood cell transfusion | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Arterial haemorrhage | Vascular disorders | Non-systematic Assessment |
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| Embolism | Vascular disorders | Non-systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
| ||
| Metabolic alkalosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anaemia postoperative | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Orthofix SRL | +39-045-6719000 | danielacangiano@orthofix.it |
| Dec 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2019 | Aug 20, 2025 | ICF_001.pdf |
| 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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