IMN Diameter to Femoral Canal Diameter and Union

Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04195334

Enrollment

100

Registered

2019-12-11

Start date

2021-01-01

Completion date

2021-12-31

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Shaft Fracture

Keywords

intramedullary nail

Brief summary

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

Detailed 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.

Interventions

DEVICEinternal fixation by IMN

using retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
measurement of union clinically	6 months	we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks). then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter.
The ratio between IMN and femoral canal diameter and incidence of union objectively	6 months	We will measure union objectively using x ray (union in 3 or more cortices)

Contacts

Primary Contactmina kamal, master

minakamalcr7@gmail.com+201203380329

Backup Contactkamal el gaafary, MD

Kamalelgafary@yahoo.com+201223144899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026