Femoral Neck FracturesNCT06263309
Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis
An observational study of Femoral Neck Fractures and Femoral Neck Shortening, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes. METHODS: Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Femoral Neck Fractures, Femoral Neck Shortening
- What is being tested?
- Femoral neck shortening measurement
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent osteosynthesis for femoral neck fracture (FNF)
Who may be able to join
- Patients aged 80 years and younger
- Minimum of 2 years' follow-up
- Diagnosed with a femoral neck fracture
- Treated with either cannulated screws or a Dynamic Hip Screw (DHS).
Who cannot join
- Patients with multiple fractures in the same extremity
- Presence of malignancy
- Diagnosis of osteoporosis
- Systemic inflammatory or metabolic diseases
- Infection or malignancy in the hip joint
- Insufficient medical records
- Patients unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.
METHODS:
Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.
Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment.
- Conditions
- Femoral Neck Fractures, Femoral Neck Shortening
- Being tested
- Femoral neck shortening measurement
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral neck shortening measurementDiagnostic test
We examine femoral neck shortening in patients with femoral neck fractures.
| Study group | Role | What they receive |
|---|---|---|
| Good Functional Score | Harris hip score > 80 Receives: Diagnostic Test: Femoral neck shortening measurement | |
| Bad Functional Score | Harris Hip score < 80 Receives: Diagnostic Test: Femoral neck shortening measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip score
Hip functional score
Measured: minimum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Samet Gokceoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263309
- Sponsor's protocol ID
- Femoralneckfracture
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis
- ClinicalTrials.gov ID
- NCT06263309
- Acronym / sponsor ID
- Femoralneckfracture
- Conditions
- Femoral Neck Fractures, Femoral Neck Shortening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 16 Feb 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.
OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.
METHODS:
Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.
Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Functional Score | – | Diagnostic Test: Femoral neck shortening measurementHarris hip score > 80 |
| Bad Functional Score | – | Diagnostic Test: Femoral neck shortening measurementHarris Hip score < 80 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent osteosynthesis for femoral neck fracture (FNF)
Key inclusion criteria (4 listed)
- Patients aged 80 years and younger
- Minimum of 2 years' follow-up
- Diagnosed with a femoral neck fracture
- Treated with either cannulated screws or a Dynamic Hip Screw (DHS).
Key exclusion criteria (7 listed)
- Patients with multiple fractures in the same extremity
- Presence of malignancy
- Diagnosis of osteoporosis
- Systemic inflammatory or metabolic diseases
- Infection or malignancy in the hip joint
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 |
|---|---|---|
| Femoral neck shortening measurementWe examine femoral neck shortening in patients with femoral neck fractures. | Diagnostic test | Bad Functional Score, Good Functional Score |
Primary outcome
Harris Hip score
Time frame: minimum 2 years
Hip functional score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures and Femoral Neck Shortening, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 16 Feb 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Harris Hip score (time frame: minimum 2 years). 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 16 Feb 2024.