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The proven hyaluronic acid treatment for facet joint arthrosis.Hyaluronic Acid, Sodium Salt 1.0 %

Dear user,The prevalence of specific and non-specific back pain is constantly in-

creasing. Acute pain often disappears on its own in most cases. The rest,

however, persist for several months, so that one can speak of chronic

back pain. A possible trigger for pain is the facet syndrome. The facet

syndrome (Fig. a) is a chronic pain syndrome caused by irritation of the

nociceptors in the joint capsule. The main causes are chronic overload,

facet joint incongruence due to disc degeneration or arthrosis. The lum-

bar spine is most frequently affected. Patients mostly complain of

long-lasting and often difficult to treat pain.

The clinical diagnosis of the facet syndrome is difficult to determine.

Typical features are painful muscle tension, local pressure and/or knock-

ing pain over the spinous processes as well as motion-dependent pain in

the area of the paravertebral muscles.

In early stages of facet joint arthrosis, conservative treatment is indicat-

ed (physiotherapy, possibly supported by oral analgesics or anti-inflam-

matory drugs). Further treatment options are facet joint infiltrations

with local anaesthetics and/or corticosteroids. In addition, procedures

such as percutaneous thermo- and cryodenervation are also available 2.

The treatment with Spinevisc® hyaluronic acid is particularly successful

in early stages of facet joint arthrosis. It is recommended to repeat the

Spinevisc® treatment 3 – 5 times in weekly intervals to achieve a success-

ful clinical outcome. The treatment can be repeated several times with-

in 12 months1.

Fig. a: Facet syndrome

2

What is Spinevisc®? ] a highly pure, non-crosslinked hyaluronic acid with an average molecular weight of

1.2 – 1.4 Mio. kD (Kilodalton), similar to the body‘s own hyaluronic acid

] biotechnologically, fermentatively produced in a patented process in Europe (Pharm.-Eur.)

] purely biomimetic hyaluronic acid without any microbiological impurities

] very well tolerated and physiologically degradable1

] an alternative to corticosteroids, percutaneous thermo, cryo- and sodium chloride infiltration2

] another option in the treatment cascade of the facet syndrome

%

50.0

45.0

40.0

35.0

30.0

25.0

20.0

15.0

10.0

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Clinical Efficacy Assessment8

] 37 % freedom from symptoms vs. 49 % clear improvement (N = 79 patients)

Why Spinevisc®? ] CE certified for the treatment of facet joint arthrosis

] clinically tested and proven for the use on facet joints3

] 90 % proven patient satisfaction4

] improves the lubricating and shock-absorbing properties of the body’s own synovial fluid and is

anti-inflammatory5

] clinically effective alternative to anti-inflammatory drugs and antirheumatic drugs6

] the Spinevisc® treatment may be repeated 3 – 5 times in weekly intervals (depending on the

patient’s pain level)7. The treatment can be repeated several times within 12 months1

Significant improvement

49.3

Complaint- free

36.7

Slight improvement

Unchanged

3.8

Slight deterioration

1.3

Significant deterioration

1.3

7.6

3

Assessment of individual pain status, criteria rest pain and movement pain9

The symptoms of pain and discomfort decreased continuously during the 3-week treatment cycle

with Spinevisc® for all criteria. Therapy success continued with most patients even after completion

of the 3-week treatment cycle.

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1

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1

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T0: Prior therapy

(T1 – T3: after denervation before injection 1, 2 and 3)

(T1 – T3: after denervation before injection 1, 2 and 3)

T0: Prior therapy

T1: Prior injection 1

T1: Prior injection 1

T2: Prior injection 2

T2: Prior injection 2

T3: Prior injection 3

T3: Prior injection 3

T4: After therapy

T4: After therapy

VAS – Rest Pain (N = 79 patients)

VAS – Movement Pain (N = 79 patients)

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Exemplary infiltration technique with Spine visc®

For the treatment of facet joint arthrosis

(Fig. b), which is often referred to as the

„facet syndrome“ and which leads to severe

back pain, intra-articular facet joint infiltra-

tion with Spinevisc® can be performed.

Fig. b: Lumbar facet joints

Fig. c: Cartilage surfaces of the facet joints

The facet joints contain opposite cartilage

surfaces (Fig. c), which reduce friction

between the bones.

Fig. d: Capsule with synovial fluid

The joint is surrounded by a capsule filled

with a small amount of synovial fluid (Fig. d).

The synovial fluid acts as a lubricant to

reduce friction between the rubbing facet

joints. Healthy facet joints support the spine

while allowing a wide range of rotational

and bending movements (flexion/extension).

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4

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Fig. e: Vertebral facet joints affected by facet joint arthrosis

Fig. f: Lumbar facet joint diagnosis

Fig. g: Needle guidance into the facet joints

Fig. h: Injection of contrast dye

The facet joints can become inflamed and

painful due to a variety of diseases such as

arthrosis. (Fig. e)

The patient is brought into the abdominal or

knee position.

A needle is then guided into the facet joints

using fluoroscopy under aseptic conditions.

(Fig. g)

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Before a facet joint infiltration with

Spinevisc® hyaluronic acid, the facet joints

should be diagnosed as the source of pain.

If local anaesthetics or corticosteroids are

contraindicated, sodium chloride solution

alone may be injected under aseptic condi-

tions. (Fig. f)

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Contrast dye can be injected to confirm that

the needle is properly positioned into the

facet joints.

Note: This surgical step is recommended but

not mandatory if a contrast dye intolerance

is indicated.

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After the facet joint infiltration with Spinevisc® it is recommended to monitor the patient for about

one hour by means of electrocardiogram (ECG) and blood pressure measurement, to pay attention

to physical reactions and to check the physical mobility of the patient. It is not recommended to

drive a motor vehicle directly after the procedure.

It is recommended to repeat the Spinevisc® treatment 3 – 5 times in weekly intervals (depending

on patient’s pain level) to achieve a successful clinical outcome7. The treatment can be repeated

several times within 12 months1.

Fig. i: Injection of anaesthetics and anti- inflammatory drugs

Fig. j: Infiltration under fluoroscopy

Fig. k: Spinevisc® injection

After confirmation of the needle positioning,

a mixture of anaesthetics and anti-

inflammatory drugs is slowly injected into

the facet joints. (Fig. i)

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The injection needle is placed on the cone of

the Spinevisc® syringe and the hyaluronic

acid is then slowly injected into the facet

joints under fluoroscopic control.

Note: It is recommended to inject 1 ml

Spinevisc® per facet joint10.

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After the injection of the anaesthetics and

anti-inflammatory drugs, the needle posi-

tioning and direction in the facet joints

should be reconfirmed under fluoroscopy.

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Disclaimer

This document is intended exclusively for experts in the field, i.e. physicians in particular, and is expressly not for the information of laypersons.

The information on the products and/or procedures contained in this document is of a general nature and does not represent medical advice or recommendations. Since this information does not constitute any diagnostic or therapeutic statement with regard to any individual medical case, individual examination and advising of the respective patient are absolutely necessary and are not replaced by this document in whole or in part.

Literature1, 3, 4, 6, 7, 8, 9 Keller H. Treatment of facet joint arthropathy with hyaluronic acid. OUP 2014; 10: 484–489 DOI 10.3238/oup.2014.0484–04892 Lange A. Injection techniques in the lumbar spine. OUP 2012; 1 (12) : DOI 10.3238/oup.2012.0484–04945 Altman R. Anti-inflammatory effects of intra-articular hyaluronic acid. Cartilage, Feb. 2018 / Litwiniuk M. et al. Hyaluron-

ic Acid in Inflammation and Tissue Regeneration. woundsresearch.com/article/hyaluronic-acid-inflammation-and-tis-sue-regeneration / Masuko K. et al. Anti-inflammatory effects of hyaluronan in arthritis therapy: Not just for viscosity. International Journal of General Medicine 28 April 2009

10 Spinevisc® Instructions For Use

The proven hyaluronic acid treatment for facet joint arthrosis.

REF. no. Size Content Pack size9210 000 004 pre-filled syringe -

20 mg / 2 ml

pc. 1

curasan AGLindigstrasse 4 | 63801 Kleinostheim | Germany

info@curasan.de | www.curasan.deTel.: +49 6027 / 40 900 - 0 | Fax: +49 6027 / 40 900 - 49 11

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Spine visc®