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OpenTrials
Completed

NCT Number: NCT02190435

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stryker ADAPT computer-assisted navigation

Device

Adaptive Positioning Technology for Gamma 3

Conventional technique

Device

Conventional Technique

Primary outcomes

  1. Tip-to-apex Distance

    Time frame: Intraoperative

    Distance between lag screw tip and head surface as measured on the ADAPT system

Secondary outcomes

  1. Radiation Exposure

    Time frame: Intraoperative

    Intraoperative fluoroscopy exposure time for lag screw placement (seconds)

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2014
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.