Clinical trial NCT05197335: Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Subtrochanteric Fractures
Intertrochanteric Fractures
Pertrochanteric Fracture
Keywords: Femur
Fracture
Femoral
Nail
Nailing
Trochanteric
Sliding
Screw
Intramedullary
Elderly Patients
Lead sponsor: Orthofix s.r.l.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 213
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Patients needing a Second Surgery
timeFrame: 6 months
Secondary outcomes:
measure: Functional Score of Bowers & Parker
timeFrame: 12 months
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Regionale EE 'Miulli'
state: BA
city: Caserta
country: Italy
facility: A.O. Sant'Anna e San Sebastiano Caserta
state: CE
city: Catania
country: Italy
facility: A.O.U. Policlinico - Vittorio Emanuele
state: CT
city: Empoli
country: Italy
facility: Ospedale S. Giuseppe
state: FI
city: Firenze
country: Italy
facility: Az. Ospedaliero - Universitaria Careggi
state: FI
city: Mantova
country: Italy
facility: ASST di Mantova, Osp. Carlo Poma
state: MN
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato S. Stefano
state: PO
city: Vicenza
country: Italy
facility: Ospedale di Vicenza
state: VI
Study officials:
References:
citation: 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.
citation: 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.
citation: Innocenti M, Civinini R, Carulli C, Matassi F. Proximal femural fractures: epidemiology. Clin Cases Miner Bone Metab. 2009 May;6(2):117-9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.