IMN Diameter to Femoral Canal Diameter and Union

Femoral Shaft Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195334
• Other study ID #: IMN diameter and union
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2019
• Source: Assiut University
• Contact: mina kamal, master
• Phone: +201203380329
• Email: minakamalcr7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Shaft Fracture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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