Clinical trial NCT04195334: IMN Diameter to Femoral Canal Diameter and Union
Official title: Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Shaft Fracture
Keywords: intramedullary nail
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The ratio between IMN and femoral canal diameter and incidence of union objectively
timeFrame: 6 months
measure: measurement of union clinically
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: ALY MOHAMADEEN, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: mahmoud badran, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.