Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail

NCT05197335 | Completed Results

• 1 other identifier: OCI_1901
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Hip Fractures; Subtrochanteric Fractures; Intertrochanteric Fractures; Pertrochanteric Fracture

Keywords

Femur; Fracture; Femoral; Nail; Nailing; Trochanteric; Sliding; Screw; Intramedullary; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional Score of Bowers & Parker

  12 months

Study Arms (1)

Study Group

Age of 65 at the time of signing the informed consent.

Device: Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws

Interventions

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.

Study Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (8)

Ospedale Regionale EE 'Miulli'

Acquaviva delle Fonti, BA, 70021, Italy

Location

A.O. Sant'Anna e San Sebastiano Caserta

Caserta, CE, 81100, Italy

Location

A.O.U. Policlinico - Vittorio Emanuele

Catania, CT, 95123, Italy

Location

Ospedale S. Giuseppe

Empoli, FI, 50053, Italy

Location

Az. Ospedaliero - Universitaria Careggi

Florence, FI, 50134, Italy

Location

ASST di Mantova, Osp. Carlo Poma

Mantova, MN, 46100, Italy

Location

Nuovo Ospedale di Prato S. Stefano

Prato, PO, 59100, Italy

Location

Ospedale di Vicenza

Vicenza, VI, 36100, Italy

Location

Related Publications (7)

• 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.

  PMID: 24080557 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.

  PMID: 26186669 BACKGROUND

• Innocenti M, Civinini R, Carulli C, Matassi F. Proximal femural fractures: epidemiology. Clin Cases Miner Bone Metab. 2009 May;6(2):117-9.

  PMID: 22461159 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.

  PMID: 25721490 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.

  PMID: 21283071 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.

  PMID: 25662415 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.

  PMID: 27259572 BACKGROUND

Related Links

• ICJME. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals.

MeSH Terms

Conditions

Hip Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Orthofix SRL

danielacangiano@orthofix.it

+39-045-6719000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 19, 2022
• Study Start: July 9, 2020
• Primary Completion: March 31, 2022
• Study Completion: July 31, 2022
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Locations

IT (8)