Fixation of Shaft Femure Fracrture by Ender Versus Plate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intramedullary nails for group A, plate for group B.
- Who it may be relevant to
- Registry conditions: Shaft Femure Fracture in Adolescents. Basic parameters: 10 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent
Overview
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.
Interventions
- Device intramedullary nails for group A
fixation of the shaft femure fracture in this group by intramedullary nails - Device plate for group B
fixation of the shaft femure fracture in the group b by plates
Primary outcome measures
- Fracture Femure fixation by intramedullary nails versus plates [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Sohag University Hospital — Sohag
Identifiers
NCT: NCT07067333 · Soh-Med--25-5-4MS