IMN Diameter to Femoral Canal Diameter and Union

NCT ID: NCT04195334

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Femoral Shaft Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IMN and union

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

Group Type EXPERIMENTAL

internal fixation by IMN

Intervention Type DEVICE

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

Interventions

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internal 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mina kamal

orthopedic resident doctor mina kamal kamel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALY MOHAMADEEN, MD

Role: STUDY_CHAIR

Assiut University

mahmoud badran, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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mina kamal, master

Role: CONTACT

+201203380329

kamal el gaafary, MD

Role: CONTACT

+201223144899

References

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Millar MJ, Wilkinson A, Navarre P, Steiner J, Vohora A, Hardidge A, Edwards E. Nail Fit: Does Nail Diameter to Canal Ratio Predict the Need for Exchange Nailing in the Setting of Aseptic, Hypertrophic Femoral Nonunions? J Orthop Trauma. 2018 May;32(5):245-250. doi: 10.1097/BOT.0000000000001110.

Reference Type BACKGROUND
PMID: 29401087 (View on PubMed)

Shroeder JE, Mosheiff R, Khoury A, Liebergall M, Weil YA. The outcome of closed, intramedullary exchange nailing with reamed insertion in the treatment of femoral shaft nonunions. J Orthop Trauma. 2009 Oct;23(9):653-7. doi: 10.1097/BOT.0b013e3181a2a337.

Reference Type BACKGROUND
PMID: 19897987 (View on PubMed)

Rudloff MI, Smith WR. Intramedullary nailing of the femur: current concepts concerning reaming. J Orthop Trauma. 2009 May-Jun;23(5 Suppl):S12-7. doi: 10.1097/BOT.0b013e31819f258a.

Reference Type BACKGROUND
PMID: 19390369 (View on PubMed)

Collinge CA, Hymes R, Archdeacon M, Streubel P, Obremskey W, Weber T, Watson JT, Lowenberg D; Members of the Proximal Femur Working Group of the Southeast Trauma Consortium. Unstable Proximal Femur Fractures Treated With Proximal Femoral Locking Plates: A Retrospective, Multicenter Study of 111 Cases. J Orthop Trauma. 2016 Sep;30(9):489-95. doi: 10.1097/BOT.0000000000000602.

Reference Type BACKGROUND
PMID: 27144821 (View on PubMed)

Other Identifiers

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IMN diameter and union

Identifier Type: -

Identifier Source: org_study_id

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