discogel - · pdf filediscogel® discogel® rahavard teb novin part exclusive...

Discogel

Discogel

Rahavard Teb Novin Part

Exclusive Distributor of

www.partmedical.com

contact: [email protected]

[email protected]

Cell Phone: +98 9128855201

Introduction:

Chemonucleolysis is an

efficient technique for

the treatment of back pain;

it consists of a percutaneous

intradiscal injection that

dissolves the nucleus pulposus

and lowers intradiscal pressure.


History After the first use of chymopapain in 1965, it was the most widely used substance for nonsurgical treatment of herniated discs, which had an efficacy of close to 80% in lumbar and close to 85% in cervical disc hernias but was withdrawn from the market due to anaphylactic reactions to this enzyme.


After this, the search for a new material that could have the same efficacy as chymopapain but without the complications led to the use of pure ethanol for chemonucleolysis

with very good results and no allergic

complications.

New Material


Pure Ethanol is not Radio-Opaque and the injection procedure is blindly.

The high diffusibility of this liquid, and its draw back and leakage has toxic effect on Annulus Fibrosus, Cartilage, Vascular Wall, Nerve structure and Dura.


Some Problems with Pure Ethanol

It causes cytotoxic and sclerosis of vessel wall and thrombosis in all biological tissue and massive necrosis. These toxic effects of Ethanol injection produce severe pain, so it

Needs to General Anesthesia,

and also due to its toxic effects, Injection

in Cervical and Thoracic spine is

FORBIDEN.


Some Problems with Pure Ethanol

New Looks for More Security

DISCOGEL

A mixture of jellified pure ethanol and a thickening substance with tungsten powder.

Secured by:

Cellulose gel making action limiting the risk of epidural leakage of pure ethanol

Presence of tungsten particles:

Monitoring the progression of the gel through the annular cracks under Fluoroscopy and CT scan.


Among micro-invasive disc treatments, such as laser and ozone, Discogel has the most therapeutic effects and the least side effects and complications.


Some DISCOGEL Advantages

Tungsten is a non ferrous metal & therefore (in especial cases if necessary) post injection MRI can be done.

Because of the high concentration of ethylic alcohol, the risk of infection in Discogel injected patients is extremely low; and no cases have yet been reported.


In patients allergic to any chemical or drug (except alcohol, cellulose and tungsten), Discogel can be injected without any concern.

Local Anesthesia (usually 3-5 ml Lidocaein)

Absence of immediate and late Generalysed or Local complications.

The lack of disc space narrowing.


Discogel injection is an outpatient procedure and

admission can be limited to 3-4 hours maximum.

This is the reason why in addition to reduced hospitalization;

there is an important impact on costs.


Local Anesthesia (usually 3-5 ml Lidocaein)

Absence of immediate and late Generalized or Local complications.

The lack of disc space narrowing.


Due to its jellified properties, in case of Discogel leakage into spinal canal (due to disc extrusion) no problem would be caused.

To date, no hypersensitivity reaction regarding Discogel has been reported.

In patients allergic to any chemical or drug (except alcohol, cellulose and tungsten), Discogel can b injected without any concern.


To follow up patients treated with Discogel, clinical observations, plain X-Ray and CT scan can be used.

It is also suggested to postpone MRI to 9-12 months after the injection (except in special cases).


Although MRI is not the preferred method for following up Discogel treated patients,

our experience shows MR Myelography is the best view to observe the delayed decompressive effects.



Ultimate step for conservative treatment after failure of infiltrations to resisting

lumbar radicular pain

Patient Selection (Best Candidates for DISCOGEL )

Note:

The Most Important Criteria for Better Response is Correct Patient Selection

* Single Level Symptomatic HD.

* Leg Pain More than Back pain.

* No Response to medical Treatments for 4_6 weeks.

* Integrity of the Annulus fibrosus.

* Pfirmann grad 1-3 ( grade 5 is bad candidate )



Two Criteria for Better Response

More Hydrated Disc

Disc Space Narrowing Less than 50_60%

CWA. Pfirrmann. Classifica0on of disc degenera0on with MRI. Spine 26:4873-4878. 2001


* Non controlled Coagulations disorders. * Un controlled Bleeding Tendency. * Anticoagulant Therapy.

* Sever Deg. Disc Dis.

( more than 2/3 disc height Loss ).

* Primary or Metastatic Spinal Tumor.

* Prior surgical treatments at the same level.

* Potential Secondary Gain

* Calcified Disc


Relative Contraindications

Absolute Contraindications * Asymptomatic Disc Bulging as Incidental Finding In

MRI. * Canal (degenerative) & Foraminal stenosis. * Spondilolistesis. * Segmental Instability/ Fractures.

* Local and systemic infections.

* Pregnancy.

* Cauda Eq. syndrome.

* Large Extruded disc specially noncontagious Fragments.

* Efficacy of medical treatment.


Absolute Indications for Surgery

* Cauda Equaina Syndrome

(Acute or chronic Progressive Motor deficit /

Sphincter disturbance)

* Very Hyperalgic Sciatica


Failure of Discogel Injection can be due to

* Huge Obesity

* Wide and Furaminal Herniated discs

* Significant Narrowing of Disc Space

* Complex Syndrome dependent

upon 3 or more disc spaces


An Important Comparison Between Minimal Invasive Disc

Therapies


Percutaneous treatments are used in the therapy of small to medium sized hernias of intervertebral discs in order to reduce the intradiscal pressure in the nucleus and theoretically to create space for the herniated fragment to implode inwards, reducing thus pain and improving mobility and quality of life . These techniques involve the percutaneous removal of the nucleus pulposus by using a variety of chemical, thermal or mechanical techniques .


Main Types of Minimal Invasive Disc Therapies

Automated percutaneous lumbar discectomy (APLD)

Intradiscal electrothermal therapy (IDET)

Percutaneous Laser Decompression

Nucleoplasty

Percutaneous disc decompression (PDD)

Ozon

Discogel




3D CTScan After Discogel Injection

Discogel can diffuse through damaged area of disc

Thin slice CT Scan several hours after the procedure

Is recommended.




Percutaneous Treatment of Cervical Disc Hernias Using Gelified Ethanol A preliminary study J. Theron, H. Cuellar, T. Sola, L. Guimaraens, A. Casasco, P. Courtheoux J Spinal Disord Tech.20(7):526-532, October 2007

We think that this preliminary study has shown that

the efficacy of this new substance is comparable

with our experience with Chymopapain in the

treatment of disc hernias. More especially, it

demonstrated that absence of all allergic reaction in

the immediate and long term follow up for more than

4 years for the first cases


Intradiscal and Intramuscular Injection of Discogel - Radiopaque Gelified Ethanol:

Pathological Evaluation G. GUARNIERI, G. DE DOMINICIS*, M. MUTO

Neuroradiology Service, The Cardarelli Hospital; Naples, Italy * Unit of Pathology, The Cardarelli Hospital; Naples, Italy

The Neuroradiology Journal 23: 249-252, 2010

Discogel does not produce any morphostructural changes in contact with nervous structures or muscular tissue.


F.de Santis, M.DallOlio, C.Princiotta, L.Cirillo,

L.Simonetti, M.Leonardi Neuroscience Department, Neuroradiology O.U., University of

Bologna, Bellaria Hospital, Bologna, Italy

Our experience of intradiscal DiscoGel injection has been safe and effective. In our opinion, DiscoGel intradiscal injection, because of its higher cost, is a useful treatment option to be considered

when the O2-O3 chemionucleolysis fails, before recourse to surgery, or when surgery is

discogel - · pdf filediscogel® discogel® rahavard teb novin part exclusive...

Documents