- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277569
Combined Nail and Plate Fixation in Proximal Femoral Fractures With Lateral Wall Deficiency
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdelraoof Ali Mohamed Ali Morsy, Resident orthopedic surgeon
- Phone Number: 01221350719
- Email: Abdou.ali401.5@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUN-Ortho-NailPlate-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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