Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures

NCT02190435 | Completed Results DMC FDA Device

• 1 other identifier: 2014-111
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intertrochanteric Femur Fractures

Keywords

Computer-assisted navigation; ADAPT; Intramedullary nail; Intertrochanteric femur fracture

Outcome Measures

Primary Outcomes (1)

• Tip-to-apex Distance

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

  Intraoperative

Secondary Outcomes (1)

• Radiation Exposure

  Intraoperative

Study Arms (2)

ADAPT

EXPERIMENTAL

Patients that receive intramedullary nail fixation with use of the Stryker ADAPT computer-assisted navigation system

Device: Stryker ADAPT computer-assisted navigation

Control

ACTIVE COMPARATOR

Patients that receive conventional technique intramedullary nail fixation without use of the Stryker ADAPT computer-assisted navigation system

Device: Conventional technique

Interventions

Stryker ADAPT computer-assisted navigation DEVICE

Adaptive Positioning Technology for Gamma 3

ADAPT

Conventional technique DEVICE

Conventional Technique

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (4)

• 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.

  PMID: 7608228 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.

  PMID: 20832795 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.

  PMID: 19618186 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.

  PMID: 22810396 BACKGROUND

Results Point of Contact

• Title: Denise Koueiter, MS
• Organization: William Beaumont Hospital

denise.koueiter@beaumont.org

248-551-5166

Study Officials

• Kevin Grant, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)