Intertrochanteric Femur Fractures
Conditions
Keywords
Computer-assisted navigation, ADAPT, Intramedullary nail, Intertrochanteric femur fracture
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.
Interventions
DEVICEStryker ADAPT computer-assisted navigation
Adaptive Positioning Technology for Gamma 3
DEVICEConventional technique
Conventional Technique
Sponsors
Stryker Orthopaedics
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tip-to-apex Distance | Intraoperative | Distance between lag screw tip and head surface as measured on the ADAPT system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure | Intraoperative | Intraoperative fluoroscopy exposure time for lag screw placement (seconds) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADAPT Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3 | 26 |
| Control Patients that receive intramedullary nail fixation without use of the ADAPT system | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 3 consented screen fails | 3 | 0 |
| Overall Study | First 12 patients were lead-ins | 12 | 0 |
Baseline characteristics
| Characteristic | ADAPT | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 22 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 34 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Tip-to-apex Distance
Distance between lag screw tip and head surface as measured on the ADAPT system
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADAPT | Tip-to-apex Distance | 14.1 mm | Standard Deviation 3.2 |
| Control | Tip-to-apex Distance | 14.9 mm | Standard Deviation 3 |
Secondary
Radiation Exposure
Intraoperative fluoroscopy exposure time for lag screw placement (seconds)
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADAPT | Radiation Exposure | 19.4 seconds | Standard Deviation 8.8 |
| Control | Radiation Exposure | 18.8 seconds | Standard Deviation 8 |