Combined Nail and Plate Fixation in Proximal Femoral Fractures With Lateral Wall Deficiency
NCT ID: NCT07277569
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
17 participants
INTERVENTIONAL
2026-01-01
2030-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nail plate construct
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.
Proximal femoral nail with lateral plate augmentation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Proximal femoral nail with lateral plate augmentation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* AO trochanteric fractures 31A2 or 31A3 with lateral wall thickness \> 20.5 mm on pre-operative radiographs
* Injury Severity Score (ISS) ≤ 17
Exclusion Criteria
* Delayed presentation \> 3 weeks
* Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension; cardiac, renal, hepatic, or respiratory failure)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abdelraoof Ali Mohamed Ali Morsy
residant doctor at Assiut university hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon
Role: CONTACT
Phone: 01221350719
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AUN-Ortho-NailPlate-2025
Identifier Type: -
Identifier Source: org_study_id