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New nail for hip fractures tested in seniors

NCT ID NCT05197335

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how well the Chimaera intramedullary nail works in elderly patients with hip fractures. Researchers tracked 206 people aged 65 and older who had surgery with this device. The main goal was to see how many needed a second surgery due to problems, and they also measured pain, mobility, and independence during recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chimaera intramedullary nail (a metal rod inserted into the thigh bone to stabilize a hip fracture)
What this could lead to
If successful, this study will confirm that the Chimaera nail is safe and effective for treating hip fractures in elderly patients, potentially improving recovery and reducing the need for repeat surgeries.
What could go wrong
This is an observational study, not a controlled trial, so results may be less conclusive. The device is already on the market, so this is about confirming real-world performance, not a breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

206 people

The number who actually took part.

Started

Jul 2020

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • A.O. Sant'Anna e San Sebastiano Caserta

    Caserta, CE, 81100, Italy

  • A.O.U. Policlinico - Vittorio Emanuele

    Catania, CT, 95123, Italy

  • ASST di Mantova, Osp. Carlo Poma

    Mantua, MN, 46100, Italy

  • Az. Ospedaliero - Universitaria Careggi

    Florence, FI, 50134, Italy

  • Nuovo Ospedale di Prato S. Stefano

    Prato, PO, 59100, Italy

  • Ospedale Regionale EE 'Miulli'

    Acquaviva delle Fonti, BA, 70021, Italy

  • Ospedale S. Giuseppe

    Empoli, FI, 50053, Italy

  • Ospedale di Vicenza

    Vicenza, VI, 36100, Italy

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