Femoral Neck FracturesOR FNFSNCT06872970
Open Reduction in Femoral Neck Fractures
A study testing Open reduction of femoral neck fractures and internal fixation by dynamic hip screws and Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate in people with Femoral Neck Fractures, run by Samer youssef mansour meglaa at 1 site in Egypt.
Trial summary
Outcomes of open reduction and internal fixation of femoral neck fractures using dynamic hip screw versus cannulated screws combined with medial buttress plate. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Open reduction of femoral neck fractures and internal fixation by dynamic hip screws and Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients of both genders between the ages of 16 to 60 years old and had trauma caused femoral neck fracture.
- patients of both genders with Garden's type three and four femoral neck fractures
Who cannot join
- patients of both genders below the age of 16 and above 60 years old.
- patients with pathological femoral neck fractures.
- patients with autoimmune diseases like rheumatoid arthritis.
- patients with neglected femoral neck fractures(more than 1 week).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Open Reduction and Internal Fixation of Femoral Neck Fractures Using Dynamic Hip Screw vs Cannulated Screws and Medial Buttress Plate
Outcomes of open reduction and internal fixation of femoral neck fractures using dynamic hip screw versus cannulated screws combined with medial buttress plate.
Read the detailed description
-Femoral neck fractures (FNFs) in patients under the age of 50 years account for less than 5% of all hip fractures and are typically the result of a high-energy event.
FNFs in young patients, particularly displaced fractures, are challenging to treat. Internal fixation remains the consensus, and the quality of the reduction is more important than the time to surgery.
Femoral head necrosis and fracture nonunion have always been the two major complications of femoral neck fracture treatment, which greatly increases the difficulty of treatment and places a high burden on social and medical resources.
As previous studies have demonstrated, reoperation rate for a failure of internal fixation ranges from 10% to 48.8% and has remained largely unchanged over the past 30 years.
There are many options to treat femoral neck fracture. Previous studies reported that femoral neck fractures with following surgery are associated implant failure.
Currently, the most common types of fixation include cannulated screws, hip screw systems, proximal femur plates, and cephalomedullary nails. [7]
Arthroplasty may be an option for elderly patients, but is generally not feasible for young patients; young patients with FNF require a more durable and promising fixation. However, there is no consensus on the best fixation method for FNF in young patients.
CS has better biomedical properties such as anti-rotation and less invasive, which was widely used in non-displaced intracapsular fractures.
DHS could maintain the neck-shaft angle and anatomical reduction, which is helpful for fracture fixation.
A medial buttress plate can clamp the fracture apex, neutralize shearing forces, and transfer them into compressive forces into the plane of cannulated screws or other typical construct.
Thus far, there has been no optimal internal fixation method.
- Conditions
- Femoral Neck Fractures
- Being tested
- Open reduction of femoral neck fractures and internal fixation by dynamic hip screws, Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate
- Keywords
- Open reduction
- 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.
Open reduction of femoral neck fractures and internal fixation by dynamic hip screwsProcedure or surgery
Open reduction of femoral neck using watson jones or smith peterson approach fractures then fixation of fractures by dynamic hip screws
Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plateProcedure or surgery
Open reduction of femoral neck fractures then fixation of fractures by cannulated screws and medial buttress plate
| Study group | Role | What they receive |
|---|---|---|
| Open reduction of femoral neck fractures in healthy adults | Experimental | Open reduction of femoral neck fractures in healthy adults between 16 years and 60 years old using cannulated screws and medial buttress plate through watson jones or smith peterson approach Receives: Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screws; Procedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate |
| Open reduction of femoral neck fractures | Experimental | Open reduction and internal fixation of femoral neck fracture in healthy adults between 16 years and 60 years old using dynamic hip screw through watson jones or smith peterson approach Receives: Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screws; Procedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris hip score
Using harris hip score evaluate to evaluate post operative:
- pain
- amount and type of support
- limp
- distance walked
- shoes and socks
- sitting
- climbing stairs
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start12 Apr 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Model description
- Using watson-jones or smith-peterson approach in open reduction of femoral neck fractures then fixation of fractures by dynamic hip screws vs cannulated screws and medial butteess plate
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samer youssef mansour meglaa
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Samer youssef mansour meglaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872970
- Sponsor's protocol ID
- Open reduction
- Acronym
- OR FNFS
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Keshet D, Bernstein M. Open Reduction Internal Fixation of Femoral Neck Fracture-Anterior Approach. J Orthop Trauma. 2020 Aug;34 Suppl 2:S27-S28. doi: 10.1097/BOT.0000000000001818.
PubMed 32639347
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Open Reduction and Internal Fixation of Femoral Neck Fractures Using Dynamic Hip Screw vs Cannulated Screws and Medial Buttress Plate
- ClinicalTrials.gov ID
- NCT06872970
- Acronym / sponsor ID
- OR FNFS / Open reduction
- Conditions
- Femoral Neck Fractures
- Keywords
- Open reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Samer youssef mansour meglaaUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 12 Mar 2025 (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.
Outcomes of open reduction and internal fixation of femoral neck fractures using dynamic hip screw versus cannulated screws combined with medial buttress plate.
Detailed description
-Femoral neck fractures (FNFs) in patients under the age of 50 years account for less than 5% of all hip fractures and are typically the result of a high-energy event.
FNFs in young patients, particularly displaced fractures, are challenging to treat. Internal fixation remains the consensus, and the quality of the reduction is more important than the time to surgery.
Femoral head necrosis and fracture nonunion have always been the two major complications of femoral neck fracture treatment, which greatly increases the difficulty of treatment and places a high burden on social and medical resources.
As previous studies have demonstrated, reoperation rate for a failure of internal fixation ranges from 10% to 48.8% and has remained largely unchanged over the past 30 years.
There are many options to treat femoral neck fracture. Previous studies reported that femoral neck fractures with following surgery are associated implant failure.
Currently, the most common types of fixation include cannulated screws, hip screw systems, proximal femur plates, and cephalomedullary nails. [7]
Arthroplasty may be an option for elderly patients, but is generally not feasible for young patients; young patients with FNF require a more durable and promising fixation. However, there is no consensus on the best fixation method for FNF in young patients.
CS has better biomedical properties such as anti-rotation and less invasive, which was widely used in non-displaced intracapsular fractures.
DHS could maintain the neck-shaft angle and anatomical reduction, which is helpful for fracture fixation.
A medial buttress plate can clamp the fracture apex, neutralize shearing forces, and transfer them into compressive forces into the plane of cannulated screws or other typical construct.
Thus far, there has been no optimal internal fixation method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using watson-jones or smith-peterson approach in open reduction of femoral neck fractures then fixation of fractures by dynamic hip screws vs cannulated screws and medial butteess plate
| Arm | Type | Receives |
|---|---|---|
| Open reduction of femoral neck fractures in healthy adults | Experimental | Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screws, Procedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plateOpen reduction of femoral neck fractures in healthy adults between 16 years and 60 years old using cannulated screws and medial buttress plate through watson jones or smith peterson approach |
| Open reduction of femoral neck fractures | Experimental | Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screws, Procedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plateOpen reduction and internal fixation of femoral neck fracture in healthy adults between 16 years and 60 years old using dynamic hip screw through watson jones or smith peterson approach |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients of both genders between the ages of 16 to 60 years old and had trauma caused femoral neck fracture.
- patients of both genders with Garden's type three and four femoral neck fractures
Key exclusion criteria (4 listed)
- patients of both genders below the age of 16 and above 60 years old.
- patients with pathological femoral neck fractures.
- patients with autoimmune diseases like rheumatoid arthritis.
- patients with neglected femoral neck fractures(more than 1 week).
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 |
|---|---|---|
| Open reduction of femoral neck fractures and internal fixation by dynamic hip screwsOpen reduction of femoral neck using watson jones or smith peterson approach fractures then fixation of fractures by dynamic hip screws | Procedure or surgery | Open reduction of femoral neck fractures, Open reduction of femoral neck fractures in healthy adults |
| Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plateOpen reduction of femoral neck fractures then fixation of fractures by cannulated screws and medial buttress plate | Procedure or surgery | Open reduction of femoral neck fractures, Open reduction of femoral neck fractures in healthy adults |
Primary outcome
Harris hip score
Time frame: 3 years
Using harris hip score evaluate to evaluate post operative: 1. pain 2. amount and type of support 3. limp 4. distance walked 5. shoes and socks 6. sitting 7. climbing stairs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 32639347Keshet D, Bernstein M. Open Reduction Internal Fixation of Femoral Neck Fracture-Anterior Approach. J Orthop Trauma. 2020 Aug;34 Suppl 2:S27-S28. doi: 10.1097/BOT.0000000000001818.
- Individual participant dataSharing planned: Yes
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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?
A study testing Open reduction of femoral neck fractures and internal fixation by dynamic hip screws and Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate in people with Femoral Neck Fractures, run by Samer youssef mansour meglaa 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 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: 3 years). 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 NCT06872970, which also lists 1 linked publication.
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 12 Mar 2025.