Clinical trial NCT02190435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intertrochanteric Femur Fractures
Keywords: Computer-assisted navigation
ADAPT
Intramedullary nail
Intertrochanteric femur fracture
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2014-07-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tip-to-apex Distance
timeFrame: Intraoperative
Secondary outcomes:
measure: Radiation Exposure
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kevin Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.