Hip FractureNCT06357312
Influence of Static Distal Locking of a Short Proximal Femoral Nail
A study testing hip trochanteric nail in people with Hip Fracture, run by Elda University Hospital at 1 site in Spain.
Trial summary
Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- hip trochanteric nail
- 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 Apr 2024to 1 Apr 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 50 years old
- With unstable intertrochanteric hip fracture
- Operated in the first 48 hours after hospital admission
Who cannot join
- Simultaneous associated fractures
- Fractures with subtrochanteric line
- Non-acute fractures
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Elda University Hospital
Elda, Valencia, 03600
FRANCISCO ANTONIO MIRALLES MUÑOZ, 651552115, fr_miralles@hotmail.com
About this study
Official title: Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail
Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.
Read the detailed description
Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.
- Conditions
- Hip Fracture
- Being tested
- hip trochanteric nail
- Keywords
- hip, fracture, intertrochanteric, elderly, screw
- Medical subject headings
- Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip trochanteric nailDevice
hip trochanteric nail with and without distal interlocking screw
| Study group | Role | What they receive |
|---|---|---|
| Group with distal screw | Experimental | Patients who have been randomly selected for this procedure are included. Receives: Device: hip trochanteric nail |
| Group without distal screw | Experimental | Patients who have been randomly selected for this procedure are included. Receives: Device: hip trochanteric nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional status using the Barthel index
Evaluation of functional status 12 months after hip surgery
Measured: 12 months
Secondary outcomes (2)
Postoperative mechanical complications
Complication rate with nail, cephalic screw, or distal screw
Measured: 12 months
Parker mobility scale
Assessment of the patient's mobility capacity before and 12 months after hip surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2024
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Prospective, comparative, randomized and double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elda University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Antonio Miralles-Muñoz, Elda University Hospital
- Investigators
- Carlos De la Pinta Zazo, Principal investigator, Elda University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357312
- Sponsor's protocol ID
- 2023/11P
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail
- ClinicalTrials.gov ID
- NCT06357312
- Acronym / sponsor ID
- 2023/11P
- Conditions
- Hip Fracture
- Keywords
- hip, fracture, intertrochanteric, elderly, screw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Elda University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 10 Apr 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.
Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.
Detailed description
Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, comparative, randomized and double-blind study
| Arm | Type | Receives |
|---|---|---|
| Group with distal screw | Experimental | Device: hip trochanteric nailPatients who have been randomly selected for this procedure are included. |
| Group without distal screw | Experimental | Device: hip trochanteric nailPatients who have been randomly selected for this procedure are included. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 50 years old
- With unstable intertrochanteric hip fracture
- Operated in the first 48 hours after hospital admission
Key exclusion criteria (3 listed)
- Simultaneous associated fractures
- Fractures with subtrochanteric line
- Non-acute fractures
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 |
|---|---|---|
| hip trochanteric nailhip trochanteric nail with and without distal interlocking screw | Device | Group with distal screw, Group without distal screw |
Primary outcome
Evaluation of functional status using the Barthel index
Time frame: 12 months
Evaluation of functional status 12 months after hip surgery
2 secondary outcomes
Postoperative mechanical complications
Time frame: 12 months
Parker mobility scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Carlos De la Pinta Zazo principal investigator
Elda University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hip trochanteric nail in people with Hip Fracture, run by Elda 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FRANCISCO ANTONIO MIRALLES MUÑOZ (651552115, fr_miralles@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of functional status using the Barthel index (time frame: 12 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 10 Apr 2024.