Intertrochanteric Femur Fractures Clinical Trial
Official title:
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
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.
| Status | Completed |
| Enrollment | 65 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| William Beaumont Hospitals | Stryker Orthopaedics |
United States,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | tip-to-apex distance | Distance between lag screw tip and head surface as measured on the ADAPT system | Intraoperative | Yes |
| Secondary | Radiation exposure | Intraoperative fluoroscopy exposure time for lag screw placement (seconds) | Intraoperative | Yes |