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.

Study Overview

• Status: Completed
• Conditions: Intertrochanteric Femur Fractures
• Intervention / Treatment: Device: Stryker ADAPT computer-assisted navigation; Device: Conventional technique

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADAPT; Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system	Device: Stryker ADAPT computer-assisted navigation; Adaptive Positioning Technology for Gamma 3
Active Comparator: Control; Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system	Device: Conventional technique; Conventional Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tip-to-apex Distance	Distance between lag screw tip and head surface as measured on the ADAPT system	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure	Intraoperative fluoroscopy exposure time for lag screw placement (seconds)	Intraoperative

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Collaborators: Stryker Orthopaedics
• Investigators: Principal Investigator: Kevin Grant, MD, William Beaumont Hospitals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ADAPT; Intramedullary nail; Computer-assisted navigation; Intertrochanteric femur fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 2014-111 (Barbara Ann Karmanos Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes