Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Fracture Femure fixation by intramedullary nails versus plates
Study Overview
Brief Summary
The aim of this study is to compare the
- functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent.
- Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance).
- Evaluate complications such as infection, nonunion, malunion, refractures, and need for reoperation (e.g., hardware removal).
Detailed Description
Elastic Nails (EN) are flexible intramedullary devices, usually made of titanium or stainless steel, that allow for dynamic stabilization. They are typically used for fractures in children and adolescents. The intramedullary nails offer the advantage of minimally invasive insertion, less disruption of the periosteum, and potential for less disruption of the growth plate.The nails bend and allow for some motion at the fracture site, which promotes healing through the formation of callus.
Plate fixation typically involves a compression or neutralization plate, usually a dynamic compression plate (DCP) or a locking plate. This method provides rigid stabilization but often requires more extensive dissection and can interfere with growth if the plate is applied too close to the physis (growth plate).While plating can be very effective in providing stability, there is a higher risk of complications such as hardware-related issues (e.g., plate prominence, need for removal) and potential growth disturbances.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).
- •Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.
- •Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).
Exclusion Criteria
- •• Fractures with significant comminution or open fractures (Grade II or III).
- •Pathological fractures (e.g., secondary to bone disease).
- •Severe systemic conditions that may affect bone healing or postoperative recovery (e.g., metabolic bone diseases).
- •Patients with previous ipsilateral femur fractures or those requiring re-operation for non-union or malunion.
Arms & Interventions
group A for intramadullary nail
fixation of the femure in group A by intramedullary nails
Intervention: intramedullary nails for group A (Device)
group B for plating
fixation of the shaft femure fracture in group B by plates
Intervention: plate for group B (Device)
Outcomes
Primary Outcomes
Fracture Femure fixation by intramedullary nails versus plates
Time Frame: 6 months
limb length discrepancy by planning X rays.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Hashem Ahmed
lecturer
Sohag University