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NCT02190435 · ClinicalTrials.gov registry record · NA
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
A NA study of Intertrochanteric Femur Fractures, sponsored by Corewell Health East.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT02190435: Completed NA study of Intertrochanteric Femur Fractures, sponsored by Corewell Health East.
NCT02190435 is a NA study of Intertrochanteric Femur Fractures that has completed, run by Corewell Health East. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02190435, a NA study of Intertrochanteric Femur Fractures, has completed, sponsored by Corewell Health East.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study 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 convention
Primary Outcome
Distance between lag screw tip and head surface as measured on the ADAPT system
Conditions Studied
Interventions
- DEVICE Stryker ADAPT computer-assisted navigation
- DEVICE Conventional technique
Study Locations (1)
Michigan
- William Beaumont Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT02190435 record still lists
NCT02190435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Intertrochanteric Femur Fractures appearing as the primary indexed condition, and to 2 interventions - of which Stryker ADAPT computer-assisted navigation is the first listed.
NCT02190435 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02190435 about?
NCT02190435 is a clinical study titled "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 a...
What is the current status of trial NCT02190435?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2014-07. Estimated completion is 2016-01.
What conditions does trial NCT02190435 study?
This clinical trial studies the following conditions: Intertrochanteric Femur Fractures.
What interventions are being tested in trial NCT02190435?
The interventions under investigation include: Stryker ADAPT computer-assisted navigation (DEVICE), Conventional technique (DEVICE).
Who is sponsoring clinical trial NCT02190435?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02190435 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02190435's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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