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Treatment Options for Cervical RadiculopathyKey Message: While there are a couple of systems that appear to be similar in concept to DTRAX, e.g. Facet Lift, TrueFuse, etc., they do not offer equivalent solutions, and are not making significant market impact as of yet. By far the largest opportunities for DTRAX are in the ACDF and Foraminotomy spaces.

Note: Radiculopathy (Cervical)Some people have neck pain that may radiate into the shoulder and arm. This type of pain is often caused by an injury near the root of a spinal nerve. A nerve root injury is sometimes referred to as a "pinched" nerve. The medical term for this condition is cervical radiculopathy..1

Dr.XXXXXXXXXXXX, M.D.LocationSpecializes in Affiliated with Multiple HospitalsExample 1Example 2Degree from

What causes Neck Pain?

Neck Pain SourcesMuscle PainSpinal Column

The cervical vertebrae of the spine consist of seven bony rings that reside in the neck between the base of the skull and the thoracic vertebrae in the trunk. Among the vertebrae of the spinal column, the cervical vertebrae are the thinnest and most delicate bones. Yet, in spite of their size, the cervical vertebrae have the huge jobs of supporting the head, protecting the spinal cord, and providing mobility to the head and neck.4

Neck Pain, Spinal ColumnLateral (Side)Cross SectionEach cervical vertebra consists of a thin ring of bone, orvertebral arch, surrounding the vertebral and transverse foramina. Thevertebral foramenis a large opening in the center of the vertebra that provides space for the spinal cord and its meninges as they pass through the neck. Flanking the vertebral foramen on each side are the much smaller transverse foramina. The transverse foramina surround the vertebral arteries and veins, which, along with the carotid arteries and jugular veins, have the vital job of carrying blood to and from the brain.

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Neck Pain, Spinal Column

Each cervical vertebra is named by its position in order from superior (C1 or first cervical vertebra) to inferior (C7 or seventh cervical vertebra). The C1 vertebra, which holds up the skull, is named theatlasafter the mythological titan Atlas who similarly held the Earth on his shoulders. Similar to the C1 vertebra, the C2 vertebra is named theaxisas it provides the axis upon which the skull and atlas rotate when the head is moved side to side.

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Neck Pain, Discs7

Neck Pain, Discs

Bulging Disc8

Neck Pain, Pinched NerveMedical Term: Cervical RadiculopathyA nerve root injury is sometimes referred to as a "pinched" nerve. The medical term for this condition is cervical radiculopathy.9Neck Pain, Pinched Nerve

Ruptured DiscBone (Stenosis)A nerve root injury is sometimes referred to as a "pinched" nerve. The medical term for this condition is cervical radiculopathy.10Neck Pain, Pinched Nerve

Herniated Disk

Foraminal StenosisA nerve root injury is sometimes referred to as a "pinched" nerve. The medical term for this condition is cervical radiculopathy.11Cervical Radiculopathy, CausesOften caused by degeneration of the spine (arthritis, spondylosis)

As the disks lose height, the vertebrae move closer together. The body sees the collapsed disk as a possible weak area and responds by forming more bone called spurs around the disk to strengthen it. The bone spurs that form also contribute to the stiffening of the spine. Bone spurs may also narrow the area of the foramen and pinch the nerve root.The disk changes that occur with age are often called arthritis or spondylosis. It is important to keep in mind that all these changes are "normal" and they occur in everyone. In fact, if MRI scans were performed on all people aged 50 or older, nearly half of the scans would show worn disks and pinched nerves that do not cause painful symptoms. It is not known why some patients have symptoms and others do not.12

Neck Pain

Arm pain, tingling, and/or numbness

Headaches

Cervical Radiculopathy, SymptomsThe main symptom of cervical radiculopathy is pain that spreads into the arm, neck, chest, upper back and/or shoulders. A person with radiculopathy may experience muscle weakness and/or numbness or tingling in fingers or hands. Other symptoms may include lack of coordination, especially in the hands.13

Treatment Options for Cervical RadiculopathyKey Message: While there are a couple of systems that appear to be similar in concept to DTRAX, e.g. Facet Lift, TrueFuse, etc., they do not offer equivalent solutions, and are not making significant market impact as of yet. By far the largest opportunities for DTRAX are in the ACDF and Foraminotomy spaces.

Note: Radiculopathy (Cervical)Some people have neck pain that may radiate into the shoulder and arm. This type of pain is often caused by an injury near the root of a spinal nerve. A nerve root injury is sometimes referred to as a "pinched" nerve. The medical term for this condition is cervical radiculopathy..14Treatments, ACDFACDF (Anterior Cervical Discectomy & Fusion)

Anterior from the frontCervical in the neck portion of the spineDiscectomy removes disc materialFusion joins two or more vertebrae 15

ACDF, Procedure OverviewTheneurosurgeonororthopedic surgeonenters the space between two discs through a small incision in front (= anterior) of and at the right or left side of the neck. The disc is completely removed, as well asarthriticbone spurs. The disc material, pressing on the spinal nerve or spinal cord, is then completely removed. Theintervertebral foramen, the bone channel through which the spinal nerve runs, is then enlarged with a drill giving the nerve more room to exit the spinal canal.To prevent the vertebrae from collapsing and to increase stability, the open space is often filled withbone graft, taken from thepelvisor cadaveric bone. The slow process of the bone graft joining the vertebrae together is called "fusion". Sometimes atitaniumplate is screwed on the vertebrae or screws are used between the vertebrae to increase stability during fusion, especially when there is more than one disc involved.16ACDF, Procedure OverviewACDF (Anterior Cervical Discectomy & Fusion)

To prevent the vertebrae from collapsing and to increase stability, the open space is often filled withbone graft, taken from thepelvisor cadaveric bone. The slow process of the bone graft joining the vertebrae together is called "fusion". Sometimes atitaniumplate is screwed on the vertebrae or screws are used between the vertebrae to increase stability during fusion, especially when there is more than one disc involved.17ACDF, Possible ComplicationsHoarsenessSwallowing disturbanceInfectionBlood lossNerve injury or paralysisNeed for further surgeryHemorrhage or formation of a wound hematomaDamage to the carotid or vertebral artery resulting in a stroke or excessive bleeding, even deathDamage to the esophagus or trachea resulting in infectionDamage to the dura, resulting in a cerebrospinal fluid leak or pocket of cerebral spinal fluid beneath the incision (pseudomeningocele)Mechanical complications of the graft and plate (including graft migration, breakage of the plate, screw pullout, etc.)Wound infectionDevelopment of painful pseudoarthrosis (failure of adequate fusion to occur)Damage to the spinal cord or nerve root(s) resulting in pain, weakness, paralysis, loss of sensation, loss of bowel or bladder function, impaired sexual function, etc.18Treatments, Artificial DiscAlso called a disc replacement or spine arthroplasty device. A device is implanted intended to preserve motion.

An artificial disc surgery may be done instead of an anterior cervical discectomy and fusion. The theoretical advantages of the artificial cervical disc over a fusion include:Maintaining normal neck motionReducing degeneration of adjacent segments of the cervical spineEliminating the need for a bone graftEarly postoperative neck motionFaster return to normal activity19Artificial Disc, Procedure Overview

20Artificial Disc, Possible ComplicationsSimilar to an anterior cervical discectomy and fusion and may include:InfectionBlood lossNerve injury or paralysis

Note: Not ideal for patients with arthritis21Minimally Disruptive Posterior Cervical FusionIndirect DecompressionStabilization & Fusion

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DTRAX, Procedure OverviewPosterior from the backIndirect decompression lifts facets

Fusion joins two or more vertebrae

3 MM Facet Distraction Delivers 20%+ Increase in Foraminal Area Buckley et. al Foramen distraction effectiveness of the DTRAX facet screw system Tan et. al Effect of machined intra-facet allograft on foraminal height and area

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DTRAX, Procedure Overview3 MM Facet Distraction Delivers 20%+ Increase in Foraminal Area Buckley et. al Foramen distraction effectiveness of the DTRAX facet screw system Tan et. al Effect of machined intra-facet allograft on foraminal height and area

24DTRAX, Patient AdvantagesDoes not remove healthy tissue or stabilizing structuresFavorable cosmetic outcomeDoes not "burn any bridges" Does not limit options for future treatment

To prevent the vertebrae from collapsing and to increase stability, the open space is often filled withbone graft, taken from thepelvisor cadaveric bone. The slow process of the bone graft joining the vertebrae together is called "fusion". Sometimes atitaniumplate is screwed on the vertebrae or screws are used between the vertebrae to increase stability during fusion, especially when there is more than one disc involved.25

Role of MIS Posterior StabilizationSpondolytic radiculopathy & foraminal stenosisSymptomatic non-union from ACDFSupplemental stabilization & posterior fusion w/ ACDF26DTRAX: Pain Reduction in Arm

Visual Analogue Scale (VAS): ARMBaseline2 Weeks6 Weeks3 Months6 Months12 Months27

DTRAX: Pain Reduction in NeckVisual Analogue Scale (VAS): NeckBaseline2 Weeks6 Weeks3 Months6 Months12 Months28DTRAX, Comparable OutcomesNDI Outcomes vs. Traditional Cervical Operations29FAQHow Long has DTRAX Been Around?First surgery performed worldwide in 2009FDA clearance in 2013How many have been performed?DTRAX Technology has been used in over 2,000 patientsHow much experience does Dr. XXXXX have?Input information here

To prevent the vertebrae from collapsing and to increase stability, the open space is often filled withbone graft, taken from thepelvisor cadaveric bone. The slow process of the bone graft joining the vertebrae together is called "fusion". Sometimes atitaniumplate is screwed on the vertebrae or screws are used between the vertebrae to increase stability during fusion, especially when there is more than one disc involved.30