Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals (TROCHNAIL)
Primary Purpose
Femur Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antegrade Intramedullary Nail
Trigen Trochanteric Femoral Nail
Sponsored by
About this trial
This is an interventional treatment trial for Femur Fracture focused on measuring Femur Fracture, Intramedullary Nailing, Trochanteric Nailing, Piriformis Starting Portal, Trochanteric Insertion Portal
Eligibility Criteria
Inclusion Criteria:
- Fracture patterns of the proximal or middle thirds of the femur that will allow antegrade insertion of a femoral nail
- Adult patient (19 years and older)
Exclusion Criteria:
- Nonunions of the femur
- Pathologic fractures
- Documented prior femur fractures with surgical stabilization with an antegrade nail
- Patients who are pregnant, mentally disturbed, or prisoners
- Inability to comply with protocol
- Patients or family members who are unable or unwilling to sign study consent
- Any fracture too proximal or too distal to use an interlocking screw
Sites / Locations
- The University of Alabama at Birmingham, Orthopaedic Trauma
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1, A
2, B
Arm Description
Standard femoral intramedullary nail that utilizes a piriformis fossa portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur.
Trigen Trochanteric Femoral Nail (Smith & Nephew, Memphis)using a trochanteric insertion portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur
Outcomes
Primary Outcome Measures
Healed Femur Fracture
Time to clinically healed fracture as measured by weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT00593333
First Posted
December 20, 2007
Last Updated
June 1, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00593333
Brief Title
Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals
Acronym
TROCHNAIL
Official Title
Intramedullary Nailing of the Femur: A Comparison of the Trochanteric and Piriformis Starting Portals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is designed to determine whether or not the trochanteric insertion portal will show any difference when compared with the piriformis fossa portal in terms of pain and strength of the hip abductor muscles, while allowing faster surgical fixation of the femur fracture.
Detailed Description
This project is designed as a prospective, randomized, comparative study between the Trigen Trochanteric Femoral Nail (Smith & Nephew, Memphis) and a standard femoral intramedullary nail that utilizes a piriformis fossa portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur. The hypothesis is that the trochanteric insertion portal will have no difference when compared with the piriformis fossa portal in terms of pain and strength of the hip abductor muscles, while allowing faster surgical fixation of the femur fracture.
Any patient who has sustained a fracture of the femur, is at least 19 years of age, and meets the study's inclusion and exclusion criteria will be asked to participate in the study. After informed consent has been obtained, the patient will be taken to the Operating Theater for surgical fixation of the femur fracture. No fracture will be entered into the study unless antegrade femoral nailing is the treatment of choice of the attending surgeon.
The outcome variables consist of the intraoperative and postoperative adverse device effects recorded in the medical record and on the study data collection form, intraoperative and postoperative complications recorded in medical record and on the study data collection form, hip functional outcome using the WOMAC score recorded for each patient, SF-36 score recorded for each patient, results of clinical examination at 6 weeks, 3, 6, and 12 months recorded in medical record and on the study data collection form, radiographic examination evaluated by two surgeons for the presence of callus and radiographic healing recorded in the medical record and on the study data collection form. Radiographic healing at 6 weeks, 3, 6, and 12 months recorded in the medical record and on the study data collection form. (The injury severity score for all multiple trauma patients recorded on the study data collection form, and soft tissue score according to Gustillo and Anderson for open injuries and according to Tscherne for all closed injuries recorded on the study data collection form. This data will be taken into account relative to the outcome variables). The effects will be measured by clinical examination, radiographic examination, and subjective patient's outcome survey. Additionally, hip abductor muscle strength will be measured and ability to perform one leg stance and hop will be documented at 6 and 12 months.
Data will be collected and entered into EXCEL spreadsheets with double keying for quality control purposes and managed by the Department of Orthopaedic Surgery at the University of Alabama at Birmingham (UAB). After data entry is complete, the file(s) will be copied to diskette and delivered to the UAB Biostatistics statistician for analysis and report generation. The analysis will involve simple descriptive statistics (means, standard deviations, proportions) to assure balance of the treatment groups with respect to relevant variables. T-test will be used to compare the mean times to callus formation and radiographic healing between groups. Analysis of covariance will be performed if there are variables that require adjustment. Growth curve analysis (survival models) and Cox regression procedures will be used to compare the rates of callus formation and/or healing between the two groups. Assumption of proportional hazards in the model will be verified before attempting Cox regression procedures. P-values will be computed using a Mann-Whitney U test for non-parametric data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
Femur Fracture, Intramedullary Nailing, Trochanteric Nailing, Piriformis Starting Portal, Trochanteric Insertion Portal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, A
Arm Type
Active Comparator
Arm Description
Standard femoral intramedullary nail that utilizes a piriformis fossa portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur.
Arm Title
2, B
Arm Type
Experimental
Arm Description
Trigen Trochanteric Femoral Nail (Smith & Nephew, Memphis)using a trochanteric insertion portal in the treatment of fractures of the subtrochanteric and diaphyseal shaft regions of the femur
Intervention Type
Device
Intervention Name(s)
Antegrade Intramedullary Nail
Intervention Description
Use of an antegrade intramedullary nail implanted through the Piriformis fossa of the femur. The use of these nails has yielded a union rate of 97 - 99%, and has clearly become the most commonly utilized implant for femur fractures.
Intervention Type
Device
Intervention Name(s)
Trigen Trochanteric Femoral Nail
Other Intervention Name(s)
Trigen Trochanteric Femoral Nail, Smith & Nephew, Inc.
Intervention Description
Antegrade intramedullary nails developed with a proximal lateral bend that allows implantation through the greater trochanter rather than the piriformis fossa. This start portal is remarkably easier to locate and may be associated with decreased risk of abductor muscle weakness and pain.
Primary Outcome Measure Information:
Title
Healed Femur Fracture
Description
Time to clinically healed fracture as measured by weeks.
Time Frame
baseline to healed fracture (weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fracture patterns of the proximal or middle thirds of the femur that will allow antegrade insertion of a femoral nail
Adult patient (19 years and older)
Exclusion Criteria:
Nonunions of the femur
Pathologic fractures
Documented prior femur fractures with surgical stabilization with an antegrade nail
Patients who are pregnant, mentally disturbed, or prisoners
Inability to comply with protocol
Patients or family members who are unable or unwilling to sign study consent
Any fracture too proximal or too distal to use an interlocking screw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Volgas, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham, Orthopaedic Trauma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17106375
Citation
Ricci WM, Schwappach J, Tucker M, Coupe K, Brandt A, Sanders R, Leighton R. Trochanteric versus piriformis entry portal for the treatment of femoral shaft fractures. J Orthop Trauma. 2006 Nov-Dec;20(10):663-7. doi: 10.1097/01.bot.0000248472.53154.14.
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Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals
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