New nail shows promise for healing broken thighs
NCT ID NCT06285981
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
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44 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
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Dec 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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AORN Sant'Anna e San Sebastiano
Caserta, CE, 81100, Italy
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Craeggi Hospital
Florence, FI, 50134, Italy
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