Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals (TROCHNAIL)

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00593333
First received: December 20, 2007
Last updated: September 5, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention
Femur Fracture
Device: Antegrade Intramedullary Nail
Device: Trigen Trochanteric Femoral Nail

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramedullary Nailing of the Femur: A Comparison of the Trochanteric and Piriformis Starting Portals

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Healed Femur Fracture [ Time Frame: baseline to healed fracture (weeks) ] [ Designated as safety issue: No ]
    Time to clinically healed fracture as measured by weeks.


Enrollment: 110
Study Start Date: June 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, 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.
Device: Antegrade Intramedullary Nail
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.
Experimental: 2, B
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
Device: Trigen Trochanteric Femoral Nail
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.
Other Name: Trigen Trochanteric Femoral Nail, Smith & Nephew, Inc.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593333

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Smith & Nephew, Inc.
Investigators
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00593333     History of Changes
Other Study ID Numbers: F030211012
Study First Received: December 20, 2007
Results First Received: September 5, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Femur Fracture
Intramedullary Nailing
Trochanteric Nailing
Piriformis Starting Portal
Trochanteric Insertion Portal

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 22, 2014