CompletedNot Applicable

Retrospective Study Chimaera Long Nail in Adult Patient

Italy44 participantsStarted 2023-11-27

Plain-language summary

The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient expressed his willingness to participate in the Study by signing and dating informed consent.
✓. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
✓. Patients equal or older than 18 years at the time of surgery.
✓. Patients who underwent surgery performed with CHIMAERATM.
✓. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.

✕. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
✕. Patient has been diagnosed with bilateral proximal femur fractures.
✕. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
✕. 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.
✕. 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 .

Percent of Patients in Which Bone Union Has Been Achieved

Timeframe: 12 months

NCT IDNCT06285981

SponsorOrthofix s.r.l.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-17

Results submitted2025-07-22

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient expressed his willingness to participate in the Study by signing and dating informed consent.
✓. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
✓. Patients equal or older than 18 years at the time of surgery.
✓. Patients who underwent surgery performed with CHIMAERATM.
✓. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.

✕. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
✕. Patient has been diagnosed with bilateral proximal femur fractures.
✕. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
✕. 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.
✕. 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 .