Indirect Decompression and Fusion for Cervical Radiculopathy: DTRAX

MKT-PMT-061

Posterior Cervical Fusion Final Frontier for MIS

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??

Technology Has Not Yet Enabled This to be MIS

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Facet Screws Have Shown Promise

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Technique challenges and risk have limited adoption and lack of fusion

Goals of MIS Posterior Cervical Instrumentation

• Less Invasive Approach than Lateral Mass Screw/Rod Constructs

• Enable Fusion by Preparing Joint and Delivering Fusion Material

• Stabilize Segment

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DTRAX: Minimally Disruptive Posterior Cervical Fusion

• Minimally Disruptive Instrumentation

• Indirect Decompression

• Stabilization and Fusion

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DTRAX: Minimally Disruptive Instrumentation

• Does not remove healthy tissue or stabilizing structures

• Burns no bridges to future treatment

• Favorable cosmetic outcome

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DTRAX: Indirect Decompression

3 MM Facet Distraction Delivers 20%+ Increase in Foraminal Area

1. Buckley et. al Foramen distraction effectiveness of the DTRAX facet screw system 2. Tan et. al Effect of machined intra-facet allograft on foraminal height and area

DTRAX Implants: Expandable Cage

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• CE Mark in July 2011

• Available Outside of U.S.

DTRAX Implants: DTRAX Cervical Cage

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• 510K Clearance May 2013• First U.S. Case in November 2013• Available in Bullet Nose and Taper

The DTRAX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

DTRAX Implants: DTRAX Graft

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DTRAX Graft Specifications

• DTRAX Graft is a structural cortical allograft implant used to promote spinal fusion.

• Bench top testing supports the structural strength of DTRAX Graft.– 25+ lbs. of pullout strength*– 160+ lbs. of compressive strength*

DTRAX: Instrumentation

• Single Use Disposable

• 1 CM in Outer Diameter

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1. Access Chisel

2. Decortication Device

3. Tuning Fork Mallet

4. Guide Tube

5. Chisel Rasp

6. Implant Delivery Tool

7. Bone Graft Delivery Tool

What is the Role of MIS Posterior Stabilization?

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Spondolytic radiculopathy and foraminal stenosis

Symptomatic non-union from ACDF

Supplemental stabilization and posterior fusion w/ ACDF

DTRAX: Treatment of Cervical Radiculopathy

• First 60 Patients Treated

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Improvement in Pain Scores at 12 Months

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Baseline 2 Weeks 6 Weeks 3 Months 6 Montha 12 Months0

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Visual Analogue Scale (VAS): Arm

Improvement in Pain Scores at 12 Months

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Baseline 2 Weeks 6 Weeks 3 Months 6 Montha 12 Months0

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Visual Analogue Scale (VAS):Neck

Comparable NDI Outcomes to Accepted Cervical Operations

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Baseline 2 weeks 6 weeks 3 months 6 months 12 months 24 months0

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Cheng 2008 ACDF Cheng 2008 CDA Heller 2009 ACDFHeller 2009 CDA Mummaneni 2007 ACDF Mummaneni 2007 CDA

Minimal Changes to Lordosis

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Treated Level Lordosis

Overall Cervical Lordosis

-1.6* -0.4

*P < 0.05

Positive Fusion Rates

• 93% of Patients Fused Verified by CT

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Complications• Two Intraoperative Facet Fractures

– Access tool redesigned to address

• Two inability to access facet– Unilateral procedure performed

• No vertebral artery, nerve root or spinal cord injuries

• No implant migration

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What is the Role of MIS Posterior Stabilization?

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Spondolytic radiculopathy and foraminal stenosis

Symptomatic non-union from ACDF

Supplemental stabilization and posterior fusion w/ ACDF

Treatment of ACDF Non-Union

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Anterior Posterior

Operative Time 135 Min. 139 Min.

Hospital Stay 2.3 Days 4.4 Days

Blood Loss 103 CC 282 CC

Complication 4 Percent 8 Percent

3rd Operation 44 Percent 3 Percent

Is Posterior Fusion the Answer?

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33 Patients treated with Posterior Fusion following failed ACDF

• 4 Year Average F/U• 100% Fusion Rate• 48% Continued Pain

- 28% Mod/Severe

What is the Role of MIS Posterior Stabilization?

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Spondolytic radiculopathy and foraminal stenosis

Symptomatic non-union from ACDF

Supplemental stabilization and posterior fusion w/ ACDF

Should We Back Up Multi-Level ACDF?

• 1 Level ACDF Fusion Rate – 92%

• 2 Level ACDF Fusion Rate – 80%

• 3 Level ACDF Fusion Rate – 65%

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Is There a Role in 2-Levels ACDF?

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• 20% non-union rate in 2 level ACDF control arm

• 12% re-operation rate

Case Studies

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Summary

• Posterior cervical has not advanced as rapidly as other areas of spine

• DTRAX is a minimally-disruptive technology for posterior cervical indirect decompression and fusion

• Initial data in treatment of cervical radiculopathy promising

• Potential application in treatment of pseudoarthrosis and to supplement multi-level ACDF

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Thank You