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NCT Number: NCT07277569

Combined Nail and Plate Fixation in Proximal Femoral Fractures With Lateral Wall Deficiency

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Open fractures (Gustilo-Anderson type III)
  • Delayed presentation > 3 weeks
  • Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension; cardiac, renal, hepatic, or respiratory failure)

Treatment and study plan

Proximal femoral nail with lateral plate augmentation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to union

    Time frame: Up to 6 months

    Months from surgery to radiographic union on serial imaging.

  2. Implant failure

    Time frame: Up to 6 months

    Any mechanical failure unplanned return to OR.

  3. Complications

    Time frame: Intraoperative to 6 months

    Surgical and medical adverse events recorded prospectively.

Other outcomes

  1. Harris Hip Score (HHS)

    Time frame: 6 weeks, 3 months, 6 months

    The Harris Hip Score is a clinician-reported outcome assessing hip pain and function. Scores range from 0 to 100, with higher scores indicating better hip function.

  2. Visual Analog Scale (VAS) for pain

    Time frame: 6 weeks, 3 months, 6 months

    Pain intensity measured using the Visual Analog Scale. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

  3. Short Form-36 (SF-36)

    Time frame: 6 weeks, 3 months, 6 months

    The Short Form-36 assesses health-related quality of life across eight domains. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon

CONTACT

[email protected]

01221350719

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Nail Plate Construct in Proximal Femoral Fractures With Lateral Wall Deficiency in Skeletally Mature Patients: A Case Series Study.

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Dec 11, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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