An interventional study of Gamma 3 Nail (Stryker) and Chimaera Nail (Orthofix) in Proximal Femoral Fractures, sponsored by Puerta de Hierro University Hospital. Terminated at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Puerta de Hierro University Hospital · Not applicable, Interventional, and Treatment
The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).
Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.
Randomized, open and prospective clinical trial.
Following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. At those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (FAC) will be collected.
36 studies on the registry are indexed under Proximal Femoral Fractures; 6 are open to participants now.
This study's enrollment of 200 is above the median of 68 across 22 interventional studies indexed under Proximal Femoral Fractures.
Browse Proximal Femoral Fractures studies →Puerta de Hierro University Hospital is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Device: Gamma 3 Nail (Stryker)
A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Device: Chimaera Nail (Orthofix)
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
Incidence of cut-out.
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.
Time frame: 0-6 months
Functional Ambulatory Categories (FAC)
Classifies patients into 6 categories based on their ability and need for assistance with ambulation. Classifies patients into 6 categories based on their ability and need for help with ambulation, where 0 is equivalent to a patient with the impossibility of ambulation and 5 is a patient completely independent for ambulation.
Time frame: 0-6 months
Tip-apex distance
Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views.
Time frame: 3-6 months
Parker index
Indicates the distance of the screw from the inferior edge of the femoral neck in anteroposterior view or from the posterior edge of the femoral neck in lateral view.
Time frame: 3-6 months
Baumgaertner reduction quality criteria
3 groups are established according to the quality of reduction: good, acceptable and bad
Time frame: 3-6 months
Number of Surgical complications (Intraoperative)
Intraoperative complications
Time frame: 0-1 month
Number of Surgical complications (post-operative)
Postoperative complications
Time frame: 0-6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Jan 2026, 22 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Sep 2025 → Jan 2026 and completion Apr 2026 → Jan 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Puerta de Hierro University Hospital