Proximal Femoral FracturesNCT06293495
Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures
A study testing Gamma 3 Nail (Stryker) and Chimaera Nail (Orthofix) in people with Proximal Femoral Fractures, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Proximal Femoral Fractures
- What is being tested?
- Gamma 3 Nail (Stryker) and Chimaera Nail (Orthofix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.
- Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.
Who cannot join
- Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.
- Subcapital fracture of the proximal femur.
- Subtrochanteric fracture of the proximal femur.
- Pathological fracture.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Proximal Femoral Fractures
- Being tested
- Gamma 3 Nail (Stryker), Chimaera Nail (Orthofix)
- Keywords
- Proximal femoral fracture, Hip fracture, Cut-out
- Medical subject headings
- Proximal Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma 3 Nail (Stryker)Device
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Chimaera Nail (Orthofix)Device
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
| Study group | Role | What they receive |
|---|---|---|
| Single Cephalic Screw System | Active comparator | A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. Receives: Device: Gamma 3 Nail (Stryker) |
| Double Cephalic Screw System | Experimental | A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. Receives: Device: Chimaera Nail (Orthofix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cut-out.
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.
Measured: 0-6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 3-6 months
Baumgaertner reduction quality criteria
3 groups are established according to the quality of reduction: good, acceptable and bad
Measured: 3-6 months
Number of Surgical complications (Intraoperative)
Intraoperative complications
Measured: 0-1 month
Number of Surgical complications (post-operative)
Postoperative complications
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Why it stopped: The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femoral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective trial with a CE-marked medical devices
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro-José Torrijos-Garrido, Puerta de Hierro University Hospital
- Investigators
- Pedro José Torrijos Garrido, MD, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293495
- Sponsor's protocol ID
- CUT-OUT
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06293495
- Acronym / sponsor ID
- CUT-OUT
- Conditions
- Proximal Femoral Fractures
- Keywords
- Proximal femoral fracture, Hip fracture, Cut-out
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, prospective trial with a CE-marked medical devices
| Arm | Type | Receives |
|---|---|---|
| Single Cephalic Screw System | Active comparator | Device: Gamma 3 Nail (Stryker)A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. |
| Double Cephalic Screw System | Experimental | Device: Chimaera Nail (Orthofix)A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.
- Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.
Key exclusion criteria (4 listed)
- Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.
- Subcapital fracture of the proximal femur.
- Subtrochanteric fracture of the proximal femur.
- Pathological fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma 3 Nail (Stryker)Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system) | Device | Single Cephalic Screw System |
| Chimaera Nail (Orthofix)Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw) | Device | Double Cephalic Screw System |
Primary outcome
Incidence of cut-out.
Time frame: 0-6 months
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.
6 secondary outcomes
Functional Ambulatory Categories (FAC)
Time frame: 0-6 months
Tip-apex distance
Time frame: 3-6 months
Parker index
Time frame: 3-6 months
Baumgaertner reduction quality criteria
Time frame: 3-6 months
Number of Surgical complications (Intraoperative)
Time frame: 0-1 month
Number of Surgical complications (post-operative)
Time frame: 0-6 months
Results and safety
The study was stopped early (reason given: The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro José Torrijos Garrido, MD, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma 3 Nail (Stryker) and Chimaera Nail (Orthofix) in people with Proximal Femoral Fractures, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early because of limited clinical use of the intramedullary nail with two cephalic screws, resulting in insufficient participant recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cut-out. (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.