Femoral Neck FracturesNCT06162637
Femoral Neck Locking Plate Vs Multiple Cannulated Cancellous Screws in Treatment of Femoral Neck Fractures in Young Adults: Randomized Controlled Clinical Trial Study
A study testing femoral neck locking plate and multiple cannulated cancellous screws in people with Femoral Neck Fractures, run by Eslam Mohamed AHmed at 1 site in Egypt.
Trial summary
Fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. It is also seen in young patients with high-energy trauma. Immediate diagnosis and management are required to prevent threatening joint complications. Fracture neck femur in young adults is unsolved problem. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- femoral neck locking plate and multiple cannulated cancellous screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients (20-55) years
- having unilateral traumatic femoral neck fracture
- idependent walker before trauma without any aids
Who cannot join
- open fracture
- pathological fracture
- preexisting deformity
- other pelvic or ipsilateral femoral injuries
- renal impairment or were on high dose steroids
Trial locations and contacts
1 site in 1 country.
Abdelrahman H Khalifa, professor contact
About this study
Fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. It is also seen in young patients with high-energy trauma. Immediate diagnosis and management are required to prevent threatening joint complications. Fracture neck femur in young adults is unsolved problem. The preservation of the native hip anatomy and biomechanics is essential in active young adults. Because of the vulnerable blood supply to the femoral part of the hip joint following these fractures, there is a high risk of developing avascular necrosis (AVN) and non-union. Any sort of surgical fixation should aim at preservation the blood supply while securing enough mechanical stability until the fracture unites. Open reduction is indicated in fractures which cannot be anatomically reduced by gentle manipulation. This should be carried out without any delay since this potentially can reduce the incidence of AVN. Treatment of fracture neck femur still controversial. There are several methods for treatment of fracture neck femur as multipe cannulated cancellous screws, locking plate, dynamic hip screw (DHS) with anti-rotational screw, and arthroplasty. There is no internal fixation method superior to another. In this study, we will compare the clinical and radiographic results of femoral neck locking plate vs multiple cannulated cancellous screw in treating femoral neck fractures in young adults.
- Conditions
- Femoral Neck Fractures
- Being tested
- femoral neck locking plate, multiple cannulated cancellous screws
- 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 locking plateDevice
femoral neck fractures fixation by femoral neck locking plate
multiple cannulated cancellous screwsDevice
femoral neck fractures fixation by multiple cannulated cancellous screws
| Study group | Role | What they receive |
|---|---|---|
| A | Other | grup A with femoral neck fracture will be fixed by femoral neck locking plate Receives: Device: femoral neck locking plate |
| B | Other | grup B with femoral neck fracture will be fixed by Multiple cannulated cancellous screws Receives: Device: multiple cannulated cancellous screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of pain on the Harris Hip Score (HHS) 6 months post operative
the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores range for improvement of pain from 44 (no pain) to 0 (totally disabled cripped pain).
Measured: 6 months
Clinical evaluation of gait limping on the Harris Hip Score (HHS) 6 months post operative
the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores for limping gait range from 11 (none) to 0 (unable to walk).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam Mohamed AHmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Mohamed AHmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162637
- Sponsor's protocol ID
- Soh-Med-23-11-02MS
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Panula J, Pihlajamaki H, Mattila VM, Jaatinen P, Vahlberg T, Aarnio P, Kivela SL. Mortality and cause of death in hip fracture patients aged 65 or older: a population-based study. BMC Musculoskelet Disord. 2011 May 20;12:105. doi: 10.1186/1471-2474-12-105.
PubMed 21599967Crist BD, Eastman J, Lee MA, Ferguson TA, Finkemeier CG. Femoral Neck Fractures in Young Patients. Instr Course Lect. 2018 Feb 15;67:37-49.
PubMed 31411399Ly TV, Swiontkowski MF. Treatment of femoral neck fractures in young adults. J Bone Joint Surg Am. 2008 Oct;90(10):2254-66. No abstract available.
PubMed 18829925Haidukewych GJ, Rothwell WS, Jacofsky DJ, Torchia ME, Berry DJ. Operative treatment of femoral neck fractures in patients between the ages of fifteen and fifty years. J Bone Joint Surg Am. 2004 Aug;86(8):1711-6. doi: 10.2106/00004623-200408000-00015.
PubMed 15292419Othman YA, Khalefa AH, Ahmed IM, Ahmed KFE. Femoral neck locking plate versus multiple cannulated screws for femoral neck fractures in young adults: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Aug 18;26(1):799. doi: 10.1186/s12891-025-09019-7.
PubMed 40826062
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Neck Locking Plate Vs Multiple Cannulated Cancellous Screws in Treatment of Femoral Neck Fractures in Young Adults: Randomized Controlled Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06162637
- Acronym / sponsor ID
- Soh-Med-23-11-02MS
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eslam Mohamed AHmedUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Dec 2023 (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.
Fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. It is also seen in young patients with high-energy trauma. Immediate diagnosis and management are required to prevent threatening joint complications. Fracture neck femur in young adults is unsolved problem. The preservation of the native hip anatomy and biomechanics is essential in active young adults. Because of the vulnerable blood supply to the femoral part of the hip joint following these fractures, there is a high risk of developing avascular necrosis (AVN) and non-union. Any sort of surgical fixation should aim at preservation the blood supply while securing enough mechanical stability until the fracture unites. Open reduction is indicated in fractures which cannot be anatomically reduced by gentle manipulation. This should be carried out without any delay since this potentially can reduce the incidence of AVN. Treatment of fracture neck femur still controversial. There are several methods for treatment of fracture neck femur as multipe cannulated cancellous screws, locking plate, dynamic hip screw (DHS) with anti-rotational screw, and arthroplasty. There is no internal fixation method superior to another. In this study, we will compare the clinical and radiographic results of femoral neck locking plate vs multiple cannulated cancellous screw in treating femoral neck fractures in young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Device: femoral neck locking plategrup A with femoral neck fracture will be fixed by femoral neck locking plate |
| B | Other | Device: multiple cannulated cancellous screwsgrup B with femoral neck fracture will be fixed by Multiple cannulated cancellous screws |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients (20-55) years
- having unilateral traumatic femoral neck fracture
- idependent walker before trauma without any aids
Key exclusion criteria (5 listed)
- open fracture
- pathological fracture
- preexisting deformity
- other pelvic or ipsilateral femoral injuries
- renal impairment or were on high dose steroids
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 locking platefemoral neck fractures fixation by femoral neck locking plate | Device | A |
| multiple cannulated cancellous screwsfemoral neck fractures fixation by multiple cannulated cancellous screws | Device | B |
Primary outcome
improvement of pain on the Harris Hip Score (HHS) 6 months post operative
Time frame: 6 months
the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores range for improvement of pain from 44 (no pain) to 0 (totally disabled cripped pain).
Clinical evaluation of gait limping on the Harris Hip Score (HHS) 6 months post operative
Time frame: 6 months
the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores for limping gait range from 11 (none) to 0 (unable to walk).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 21599967Panula J, Pihlajamaki H, Mattila VM, Jaatinen P, Vahlberg T, Aarnio P, Kivela SL. Mortality and cause of death in hip fracture patients aged 65 or older: a population-based study. BMC Musculoskelet Disord. 2011 May 20;12:105. doi: 10.1186/1471-2474-12-105.
- Background: PubMed 31411399Crist BD, Eastman J, Lee MA, Ferguson TA, Finkemeier CG. Femoral Neck Fractures in Young Patients. Instr Course Lect. 2018 Feb 15;67:37-49.
- Background: PubMed 18829925Ly TV, Swiontkowski MF. Treatment of femoral neck fractures in young adults. J Bone Joint Surg Am. 2008 Oct;90(10):2254-66. No abstract available.
- Background: PubMed 15292419Haidukewych GJ, Rothwell WS, Jacofsky DJ, Torchia ME, Berry DJ. Operative treatment of femoral neck fractures in patients between the ages of fifteen and fifty years. J Bone Joint Surg Am. 2004 Aug;86(8):1711-6. doi: 10.2106/00004623-200408000-00015.
- Derived from this study: PubMed 40826062Othman YA, Khalefa AH, Ahmed IM, Ahmed KFE. Femoral neck locking plate versus multiple cannulated screws for femoral neck fractures in young adults: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Aug 18;26(1):799. doi: 10.1186/s12891-025-09019-7.
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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.
Abdelrahman H Khalifa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral neck locking plate and multiple cannulated cancellous screws in people with Femoral Neck Fractures, run by Eslam Mohamed AHmed at 1 site in Egypt.
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 5 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 19 Dec 2023. 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 Egypt. 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 Islam M Ahmed, resident (01094375737, eslammohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of pain on the Harris Hip Score (HHS) 6 months post operative (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162637, which also lists 5 linked publications.
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 19 Dec 2023.