New nail shows promise for healing broken thighs

NCT ID NCT06285981

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at how well the CHIMAERA nail, a metal rod placed inside the thigh bone, helps heal certain types of hip and upper thigh fractures. Researchers reviewed medical records of 44 adults who had the surgery to see if the bone healed within a year and if any additional surgeries were needed. The goal was to understand the nail's benefits and safety in everyday medical practice.

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 placed inside the thigh bone to stabilize fractures)
What this could lead to
If results are positive, it could confirm that this nail is a reliable option for healing specific types of thigh bone fractures.
What could go wrong
This is a small, retrospective study with only 44 patients, so findings may not apply to everyone. It also does not compare the nail to other treatments.

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

44 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 2024

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

Adults suffering from pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERATM) was part of the normal clinical practice.

Ages

18 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: 1. The patient expressed his willingness to participate in the Study by signing and dating informed consent. 2. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU. 3. Patients equal or older than 18 years at the time of surgery. 4. Patients who underwent surgery performed with CHIMAERATM. 5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study. Exclusion Criteria: 1. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet. 2. Patient has been diagnosed with bilateral proximal femur fractures. 3. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed. 4. Patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study. 5. The patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior 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

  • AORN Sant'Anna e San Sebastiano

    Caserta, CE, 81100, Italy

  • Craeggi Hospital

    Florence, FI, 50134, Italy

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