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IMN Diameter to Femoral Canal Diameter and Union

A

Assiut University

Status

Unknown

Conditions

Femoral Shaft Fracture

Treatments

Device: internal fixation by IMN

Study type

Interventional

Funder types

Other

Identifiers

NCT04195334
IMN diameter and union

Details and patient eligibility

About

To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union

Full description

Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age (20_60) years old
  2. Closed fracture and open grade one
  3. Midshaft fractures type3\2 according to the OA classification
  4. pattern of the fracture (simple transverse,oblique ,spiral)
  5. Retrograde and Antigrade nail

Exclusion criteria

  1. Open fractures grade two and three.
  2. patient with comorbidities eg(DM.HTN...)
  3. severe osteoporosis with wide medulla .
  4. patient on regular steroid therapy.
  5. patient refused to be enrolled in the study

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

IMN and union
Experimental group
Description:
putting an intramedullary nail in femoral shaft fractures and finding a relation between the nail diameter to femoral canal diameter and how this will affect healing or predict union
Treatment:
Device: internal fixation by IMN

Trial contacts and locations

0

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Central trial contact

mina kamal, master; kamal el gaafary, MD

Data sourced from clinicaltrials.gov

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