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

December 13, 2025 updated by: Abdelraoof Ali Mohamed Ali Morsy, Assiut University

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).

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon
  • Phone Number: 01221350719
  • Email: Abdou.ali401.5@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks, 3 months, and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to union
Time Frame: Up to 6 months
Months from surgery to radiographic union on serial imaging.
Up to 6 months
Implant failure
Time Frame: Up to 6 months
Any mechanical failure unplanned return to OR.
Up to 6 months
Complications
Time Frame: Intraoperative to 6 months
Surgical and medical adverse events recorded prospectively.
Intraoperative to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks, 3 months, 6 months
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.
6 weeks, 3 months, 6 months
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.
6 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AUN-Ortho-NailPlate-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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