IMN Diameter to Femoral Canal Diameter and Union

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

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

Study Overview

• Status: Unknown
• Conditions: Femoral Shaft Fracture
• Intervention / Treatment: Device: internal fixation by IMN

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mina kamal, master; Phone Number: +201203380329; Email: minakamalcr7@gmail.com
• Study Contact Backup: Name: kamal el gaafary, MD; Phone Number: +201223144899; Email: Kamalelgafary@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio between IMN and femoral canal diameter and incidence of union objectively	We will measure union objectively using x ray (union in 3 or more cortices)	6 months
measurement of union clinically	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.	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: ALY MOHAMADEEN, MD, Assiut University; Study Director: mahmoud badran, MD, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: intramedullary nail
• Other Study ID Numbers: IMN diameter and union

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No