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

February 15, 2022 updated by: Orthofix s.r.l.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Acquaviva Delle Fonti, BA, Italy, 70021
        • Ospedale Regionale EE 'Miulli'
    • CE
      • Caserta, CE, Italy, 81100
        • A.O. Sant'Anna E San Sebastiano Caserta
    • CT
      • Catania, CT, Italy, 95123
        • A.O.U. Policlinico - Vittorio Emanuele
    • FI
      • Empoli, FI, Italy, 50053
        • Ospedale S. Giuseppe
      • Firenze, FI, Italy, 50134
        • Az. Ospedaliero - Universitaria Careggi
    • MN
      • Mantova, MN, Italy, 46100
        • ASST di Mantova, Osp. Carlo Poma
    • PO
      • Prato, PO, Italy, 59100
        • Nuovo Ospedale di Prato S. Stefano
    • VI
      • Vicenza, VI, Italy, 36100
        • Ospedale di Vicenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Score of Bowers & Parker
Time Frame: 12 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthofix s.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2020

Primary Completion (ANTICIPATED)

March 31, 2022

Study Completion (ANTICIPATED)

July 31, 2022

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCI_1901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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