Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
Primary Purpose
Intertrochanteric Femur Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stryker ADAPT computer-assisted navigation
Conventional technique
Sponsored by
About this trial
This is an interventional treatment trial for Intertrochanteric Femur Fractures focused on measuring Computer-assisted navigation, ADAPT, Intramedullary nail, Intertrochanteric femur fracture
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing hip fracture fixation with a Gamma Nail by one of four orthopaedic trauma surgeons at William Beaumont Hospital Royal Oak
- Diagnosis of an intertrochanteric femur fracture (AO Classification 31-A1,A2)
- Low energy mechanism of injury (i.e. fall, twist)
Exclusion Criteria:
- Minors (less than 18 years)
- Pregnant
- Have a high energy mechanism of injury (e.g. motor vehicle accident, fall from height)
- Have an open fracture (i.e. the skin is broken at the fracture site), or
- Present with multiple injuries to the ipsilateral lower extremity
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ADAPT
Control
Arm Description
Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system
Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system
Outcomes
Primary Outcome Measures
Tip-to-apex Distance
Distance between lag screw tip and head surface as measured on the ADAPT system
Secondary Outcome Measures
Radiation Exposure
Intraoperative fluoroscopy exposure time for lag screw placement (seconds)
Full Information
NCT ID
NCT02190435
First Posted
July 11, 2014
Last Updated
April 17, 2017
Sponsor
William Beaumont Hospitals
Collaborators
Stryker Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT02190435
Brief Title
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
Official Title
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Stryker Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution.
While advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined.
The primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Femur Fractures
Keywords
Computer-assisted navigation, ADAPT, Intramedullary nail, Intertrochanteric femur fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADAPT
Arm Type
Experimental
Arm Description
Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system
Intervention Type
Device
Intervention Name(s)
Stryker ADAPT computer-assisted navigation
Intervention Description
Adaptive Positioning Technology for Gamma 3
Intervention Type
Device
Intervention Name(s)
Conventional technique
Intervention Description
Conventional Technique
Primary Outcome Measure Information:
Title
Tip-to-apex Distance
Description
Distance between lag screw tip and head surface as measured on the ADAPT system
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Radiation Exposure
Description
Intraoperative fluoroscopy exposure time for lag screw placement (seconds)
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing hip fracture fixation with a Gamma Nail by one of four orthopaedic trauma surgeons at William Beaumont Hospital Royal Oak
Diagnosis of an intertrochanteric femur fracture (AO Classification 31-A1,A2)
Low energy mechanism of injury (i.e. fall, twist)
Exclusion Criteria:
Minors (less than 18 years)
Pregnant
Have a high energy mechanism of injury (e.g. motor vehicle accident, fall from height)
Have an open fracture (i.e. the skin is broken at the fracture site), or
Present with multiple injuries to the ipsilateral lower extremity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Grant, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7608228
Citation
Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995 Jul;77(7):1058-64. doi: 10.2106/00004623-199507000-00012.
Results Reference
background
PubMed Identifier
20832795
Citation
Lobo-Escolar A, Joven E, Iglesias D, Herrera A. Predictive factors for cutting-out in femoral intramedullary nailing. Injury. 2010 Dec;41(12):1312-6. doi: 10.1016/j.injury.2010.08.009. Epub 2010 Sep 15.
Results Reference
background
PubMed Identifier
19618186
Citation
Geller JA, Saifi C, Morrison TA, Macaulay W. Tip-apex distance of intramedullary devices as a predictor of cut-out failure in the treatment of peritrochanteric elderly hip fractures. Int Orthop. 2010 Jun;34(5):719-22. doi: 10.1007/s00264-009-0837-7. Epub 2009 Jul 18.
Results Reference
background
PubMed Identifier
22810396
Citation
De Bruijn K, den Hartog D, Tuinebreijer W, Roukema G. Reliability of predictors for screw cutout in intertrochanteric hip fractures. J Bone Joint Surg Am. 2012 Jul 18;94(14):1266-72. doi: 10.2106/JBJS.K.00357.
Results Reference
background
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Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
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