Femoral FracturesNCT07277569
Combined Nail and Plate Fixation in Proximal Femoral Fractures With Lateral Wall Deficiency
A study testing Proximal femoral nail with lateral plate augmentation in people with Femoral Fractures, run by Assiut University.
Trial summary
Proximal femoral fractures are a major cause of hospitalization and disability worldwide (1). They are commonly seen among elderly patients after low-energy trauma and in younger adults after high-energy injuries and represent a major challenge in orthopaedic management (2) (3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Proximal femoral nail with lateral plate augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature patients
- AO trochanteric fractures 31A2 or 31A3 with lateral wall thickness > 20.5 mm on pre-operative radiographs
- Injury Severity Score (ISS) ≤ 17
Who cannot join
- Open fractures (Gustilo-Anderson type III)
- Delayed presentation > 3 weeks
- Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension; cardiac, renal, hepatic, or respiratory failure)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon contact
About this study
Official title: Nail Plate Construct in Proximal Femoral Fractures With Lateral Wall Deficiency in Skeletally Mature Patients: A Case Series Study.
Proximal femoral fractures are a major cause of hospitalization and disability worldwide (1). They are commonly seen among elderly patients after low-energy trauma and in younger adults after high-energy injuries and represent a major challenge in orthopaedic management (2) (3).
These fractures pose unique biomechanical challenges because of axial compression, bending forces and the strong muscle pull that leads to flexion, abduction and external rotation of the proximal fragment (4). Operative management aims to restore anatomical alignment and length to allow early mobilization and weight bearing (5).
Read more
Intramedullary devices are widely considered the preferred option for fixation of intertrochanteric fractures, including both stable and unstable types. Their biomechanical advantages include a shorter lever arm, load sharing properties, reduced bending forces, prevention of proximal fragment lateral migration, nearing to the weight-bearing axis, supporting the medial calcar, and allowance for controlled impaction. Clinically, intramedullary nails are also associated with shorter operative time, less soft tissue dissection, reduced blood loss, and earlier mobilization, leading to improved functional outcomes (6-10).
The integrity of the lateral trochanteric wall plays a crucial role in construct stability by serving as a lateral buttress. Loss of this support results in uncontrolled collapse, medialization of the femoral shaft, excessive varus deformity, and limb shortening (11-12). In a cadaveric investigation, Nie et al. (13) reported that the proximal femoral nail provides adequate support to the medial wall but fails to sufficiently stabilize the lateral wall. Furthermore, clinical evidence has shown that approximately 22% of patients with lateral wall disruption required re-operation due to unsatisfactory initial fixation (14).
To address these challenges, recent studies have proposed combined fixation using an intramedullary nail augmented with a lateral plate, aiming to enhance stability, prevent varus collapse, and improve clinical outcomes in complex proximal femoral fractures (15).
However, evidence supporting this combined approach remains limited, with most available studies being small in scale and heterogeneous. Therefore, reporting outcomes from a case series may provide valuable insights into the feasibility, safety, and effectiveness of combined nail-plate fixation, and may serve as a foundation for future comparative studies.
- Conditions
- Femoral Fractures
- Being tested
- Proximal femoral nail with lateral plate augmentation
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal femoral nail with lateral plate augmentationProcedure or surgery
Surgical fixation using a proximal femoral nail (PFN) augmented with a dynamic compression plate (DCP). Standard lateral approach; fracture reduction under fluoroscopy; temporary K-wires; plate applied to maintain reduction; PFN inserted and locked; layered closure over suction drain.
| Study group | Role | What they receive |
|---|---|---|
| Nail plate construct | Active comparator | Combined intramedullary nail and lateral plate fixation for proximal femoral fractures with lateral wall deficiency. The construct includes a proximal femoral nail (PFN) augmented by a dynamic compression plate (DCP) to enhance stability and maintain reduction. Receives: Procedure: Proximal femoral nail with lateral plate augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of fracture alignment
Radiographic assessment of fracture alignment and implant position on AP and lateral long-film femur radiographs at 2 weeks, 3 months, and 6 months postoperatively. CT will be performed at 6 months if indicated.
Measured: 2 weeks, 3 months, and 6 months postoperatively
Secondary outcomes (3)
Time to union
Months from surgery to radiographic union on serial imaging.
Measured: Up to 6 months
Implant failure
Any mechanical failure unplanned return to OR.
Measured: Up to 6 months
Complications
Surgical and medical adverse events recorded prospectively.
Measured: Intraoperative to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelraoof Ali Mohamed Ali Morsy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277569
- Sponsor's protocol ID
- AUN-Ortho-NailPlate-2025
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nail Plate Construct in Proximal Femoral Fractures With Lateral Wall Deficiency in Skeletally Mature Patients: A Case Series Study.
- ClinicalTrials.gov ID
- NCT07277569
- Acronym / sponsor ID
- AUN-Ortho-NailPlate-2025
- Conditions
- Femoral Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Dec 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.
Proximal femoral fractures are a major cause of hospitalization and disability worldwide (1). They are commonly seen among elderly patients after low-energy trauma and in younger adults after high-energy injuries and represent a major challenge in orthopaedic management (2) (3).
These fractures pose unique biomechanical challenges because of axial compression, bending forces and the strong muscle pull that leads to flexion, abduction and external rotation of the proximal fragment (4). Operative management aims to restore anatomical alignment and length to allow early mobilization and weight bearing (5).
Intramedullary devices are widely considered the preferred option for fixation of intertrochanteric fractures, including both stable and unstable types. Their biomechanical advantages include a shorter lever arm, load sharing properties, reduced bending forces, prevention of proximal fragment lateral migration, nearing to the weight-bearing axis, supporting the medial calcar, and allowance for controlled impaction. Clinically, intramedullary nails are also associated with shorter operative time, less soft tissue dissection, reduced blood loss, and earlier mobilization, leading to improved functional outcomes (6-10).
The integrity of the lateral trochanteric wall plays a crucial role in construct stability by serving as a lateral buttress. Loss of this support results in uncontrolled collapse, medialization of the femoral shaft, excessive varus deformity, and limb shortening (11-12). In a cadaveric investigation, Nie et al. (13) reported that the proximal femoral nail provides adequate support to the medial wall but fails to sufficiently stabilize the lateral wall. Furthermore, clinical evidence has shown that approximately 22% of patients with lateral wall disruption required re-operation due to unsatisfactory initial fixation (14).
To address these challenges, recent studies have proposed combined fixation using an intramedullary nail augmented with a lateral plate, aiming to enhance stability, prevent varus collapse, and improve clinical outcomes in complex proximal femoral fractures (15).
However, evidence supporting this combined approach remains limited, with most available studies being small in scale and heterogeneous. Therefore, reporting outcomes from a case series may provide valuable insights into the feasibility, safety, and effectiveness of combined nail-plate fixation, and may serve as a foundation for future comparative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nail plate construct | Active comparator | Procedure: Proximal femoral nail with lateral plate augmentationCombined intramedullary nail and lateral plate fixation for proximal femoral fractures with lateral wall deficiency. The construct includes a proximal femoral nail (PFN) augmented by a dynamic compression plate (DCP) to enhance stability and maintain reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skeletally mature patients
- AO trochanteric fractures 31A2 or 31A3 with lateral wall thickness > 20.5 mm on pre-operative radiographs
- Injury Severity Score (ISS) ≤ 17
Key exclusion criteria (3 listed)
- Open fractures (Gustilo-Anderson type III)
- Delayed presentation > 3 weeks
- Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension; cardiac, renal, hepatic, or respiratory failure)
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 |
|---|---|---|
| Proximal femoral nail with lateral plate augmentationSurgical fixation using a proximal femoral nail (PFN) augmented with a dynamic compression plate (DCP). Standard lateral approach; fracture reduction under fluoroscopy; temporary K-wires; plate applied to maintain reduction; PFN inserted and locked; layered closure over suction drain. | Procedure or surgery | Nail plate construct |
Primary outcome
Radiographic assessment of fracture alignment
Time frame: 2 weeks, 3 months, and 6 months postoperatively
Radiographic assessment of fracture alignment and implant position on AP and lateral long-film femur radiographs at 2 weeks, 3 months, and 6 months postoperatively. CT will be performed at 6 months if indicated.
3 secondary outcomes
Time to union
Time frame: Up to 6 months
Implant failure
Time frame: Up to 6 months
Complications
Time frame: Intraoperative to 6 months
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 19 Dec 2025.
- 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.
Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon contact
Questions about this trial
What is this clinical trial studying?
A study testing Proximal femoral nail with lateral plate augmentation in people with Femoral Fractures, run by Assiut University.
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: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon (01221350719, Abdou.ali401.5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment of fracture alignment (time frame: 2 weeks, 3 months, and 6 months postoperatively). 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 19 Dec 2025.