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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT | Experimental | Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system |
|
| Control | Active Comparator | Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker ADAPT computer-assisted navigation | Device | Adaptive Positioning Technology for Gamma 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tip-to-apex Distance | Distance between lag screw tip and head surface as measured on the ADAPT system | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Exposure | Intraoperative fluoroscopy exposure time for lag screw placement (seconds) | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Grant, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7608228 | Background | 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. | |
| 20832795 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADAPT | Patients that receive intramedullary nail fixation with use of the ADAPT system Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3 |
| FG001 | Control | Patients that receive intramedullary nail fixation without use of the ADAPT system |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADAPT | Patients that receive intramedullary nail fixation with use of the ADAPT system Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tip-to-apex Distance | Distance between lag screw tip and head surface as measured on the ADAPT system | Posted | Mean | Standard Deviation | mm | Intraoperative |
|
Start of surgery until end of surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADAPT | Patients that receive intramedullary nail fixation with use of the ADAPT system Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Koueiter, MS | William Beaumont Hospital | 248-551-5166 | denise.koueiter@beaumont.org |
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| Conventional technique |
| Device |
Conventional Technique |
|
| 19618186 | Background | 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. |
| 22810396 | Background | 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. |
Patients that receive intramedullary nail fixation without use of the ADAPT system
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Radiation Exposure | Intraoperative fluoroscopy exposure time for lag screw placement (seconds) | Posted | Mean | Standard Deviation | seconds | Intraoperative |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Control | Patients that receive intramedullary nail fixation without use of the ADAPT system | 0 | 24 | 0 | 24 | 0 | 24 |
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