HYALGAN

(sodium hyaluronate)
Knee Injection Workshop

USA.HYA.05.06.07

Sanofi-aventis would like to acknowledge the contributions of Dr. Todd Stitik and Dr. Michael Axe in the creation of these slides.
HYALGAN
Indications
HYALGAN is indicated for the treatment of pain
in osteoarthritis (OA) of the knee in patients who
have failed to respond adequately to
conservative nonpharmacologic therapy and to
simple analgesics, eg, acetaminophen1

Please see full prescribing information.

1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.

HYALGAN
Important Safety Information

HYALGAN is contraindicated in patients with known

hypersensitivity to hyaluronate preparations. Intra-articular
injections are contraindicated in cases of past and present
infections or skin diseases in the area of the injection site1
The effectiveness of a single treatment cycle of less than
3 injections has not been established1
In the US clinical trial of 495 patients, the only adverse event
showing statistical significance vs placebo was injection-site
pain1

Please see full prescribing information.

1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.
HYALGAN
Important Safety Information

Other adverse events included gastrointestinal complaints,

headache, local ecchymosis and rash, local joint pain and
swelling, and local pruritus. However, the incidence of these
events was similar in the HYALGAN and placebo groups1
In other clinical studies, the frequency and severity of adverse
events occurring during repeat treatment cycles did not increase
over that reported for a single treatment cycle1
Anaphylactoid and allergic reactions have been reported with
this product. In the 2 events reported as anaphylactoid reactions,
HYALGAN treatment was discontinued and both had favorable
outcomes. Three cases of allergic reactions were reported in
which the patients were discontinued from HYALGAN treatment
and the incidents resolved
Please see full prescribing information.
1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.
Procedure

1. Prepare materials
2. Position patient
3. Choose injection site
4. Mark and cleanse injection site
5. Local anesthetic administration
6. Discuss postprocedural care issues
7. HYALGAN injection
8. Immediate postprocedure phase
 1. Prepare Materials

Recommended materials1-9
Gloves HYALGAN prefilled syringe
Povidone-iodine or applicators 20 gauge x 1"-2" needle for
Gauze pads (2" x 2" or 4" x 4") HYALGAN prefilled syringe
Alcohol prep pads Adhesive bandage strip
1 mL anesthesia syringe with
needle (25-30 gauge x 1"-1")
Vapocoolant spray (optional)
1% lidocaine without epinephrine
20-50 mL aspirating syringe with
(18 gauge x 1" needle)
Clamp (hemostat)

5. Millard RS, et al. Phys Med Rehabil Clin N Am. 1995;6:841-849.

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145. 6. Rifat SF, et al. Postgrad Med. 2001;109:123-136.
2. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001. 7. Owen DS. Kelley's Textbook of Rheumatology. 2001:583-603.
3. Genovese MC. Postgrad Med. 1998;103(2):125-134. 8. Wen DY. Am Fam Physician. 2000;62:565-570.
4. Zuber TJ. Am Fam Physician. 2002;66:1497-1500. 9. Jackson DW, et al. J Bone Joint Surg. 2002;84-A:1522-1527.
1. Prepare Materials:
Preinjection Procedure

With needle and syringe

obscured from patients view:
Draw 1 mL 1% lidocaine
Change to 25-30 gauge x
1"-1" needle
If effusion present, attach
18 gauge x 1" needle to
aspirating syringe
If effusion not present, attach
20 gauge x 1"-2" needle to
HYALGAN prefilled syringe
 2. Position Patient

Make decision based on1,2

Injection approach, patient comfort,
experience
Positioning patient
Supine3,4
If palpable effusion:
suprapatellar/retropatellar approach
Knee flexion 0-10
Buttress under knee
If no palpable effusion: parapatellar
approach
Knee flexion 60-90
Foot supported
Seated2 (Patient with very difficult to
palpate landmarks)
Knee 90
Foot dangling (or supported)

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145. 3. Rifat SF, et al. Postgrad Med. 2001;109:123-136.
2. Jackson DW, et al. J Bone Joint Surg. 2002;84-A:1522-1527. 4. Cardone DA, et al. Am Fam Physician. 2003;67(10):2147-2152.
 3. Choose Injection Site:
Basic Principles

Many different approaches1

Select based on
Effusion2
If palpable joint effusion, use suprapatellar/retropatellar
approach
If no palpable joint effusion, use parapatellar approach
Supine: typical patient
Seated: patient with very difficult landmark palpation
Overlying skin3
Avoid psoriatic plaques, skin disorder
Learn more than a single approach if possible
1. Cardone DA, et al. Am Fam Physician. 2003;67:2147-2152.
2. Nicholas JJ, et al. Physical Medicine and Rehabilitation. 2000:498-514.
3. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.
3. Choose Injection Site:
Knee Injection Approaches

Suprapatellar/
Retropatellar
(aspiration and/or
injection)

Parapatellar
(injection)
 3. Choose Injection Site: Injection
Approaches and Pain Considerations
Neurosensory Mapping of the Internal Knee

Injections should be as painless as possible

Adapted from Dye SF, et al. Am J Sports Med. 1998;26:773-777.
 Accuracy of Intra-articular Needle
Placement
Summary of Knee Injection Accuracy Studies

Number of
Method Portal Accuracy Knee Position
Injections

80 Anterolateral 71% 90

Contrast
80 Anteromedial 75% 90
fluoroscopy1
Lateral
80 93% Extended
midpatellar

Contrast
59 Not defined 66% Not defined
radiography2

Mini-air
56 Superolateral 91% Not defined
radiography3

Real-time
31 Anterolateral 100% 30-40
fluoroscopy4

1. Jackson DW, et al. J Bone Joint Surg. 2002;84-A:1522-1527.

2. Jones A, et al. BMJ. 1993;307:1329-1330.
3. Bliddal H. Ann Rheum Dis. 1999;58:641-643.
4. Waddell D, et al. Am J Med Sports. 2001;3:237-241.
3. Choose Injection Site:
Accuracy of Needle Placement
Fluoroscopic Images of Intra-articular Delivery

Accurate Inaccurate
3. Choose Injection Site:
Knee Injection Approaches (contd)

Suprapatellar/retropatellar
Medial or lateral
1 oclock or 11 oclock
Parapatellar
Soft spot of the knee
Medial or lateral
5 oclock or 7 oclock
 3. Choose Injection Site:
Parapatellar Approaches (Soft Spot)

Palpate anatomic landmarks

Identify the soft spot1,2:
5 oclock or 7 oclock position
Joint line
Patellar tendon
Inferior patellar corner
Put needle into middle of this
triangle
Stay above joint line3
Aim straight into joint toward
condyle
Endpoint is condyle

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.

2. Jackson DW, et al. J Bone Joint Surg. 2002;84-A:1522-1527.
3. Wind WM Jr, et al. J Arthroplasty. 2004;19:858-861.
 3. Choose Injection Site:
Suprapatellar/Retropatellar Approaches

Palpate anatomic landmarks

Injection site1-3:
11 oclock or 1 oclock position
1 finger breadth superior to
patella
1 finger breadth superior and
posterior to quadriceps
tendon
Endpoint is successful fluid
aspiration

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.

2. Jackson DW, et al. J Bone Joint Surg. 2002;84-A:1522-1527.
3. Wind WM Jr, et al. J Arthroplasty. 2004;19:858-861.
 3. Choose Injection Site:
What Not to Do

Never inject through

the patellar tendon
Unnecessary1,2
Painful3
Incorrect place for
delivery

1. Dooley P, et al. Can Fam Physician. 2002;48:285-292.

2. Cardone DA, et al. Am Fam Physician. 2003;67:2147-2152.
3. Dye SF, et al. Am J Sports Med. 1998;26:773-777.
 4. Mark and Cleanse Injection Site

Mark the site of needle entry1,2

Parapatellar Suprapatellar/retropatellar

1. Wen DY. Am Fam Physician. 2000;62:565-570.

2. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.
 4. Mark and Cleanse Injection Site (contd)

Cleanse and disinfect the injection site1,2

Betadine swab (polymixin B sulfate and bacitracin
zinc) or applicator x 3
Alcohol prep

Parapatellar Suprapatellar/retropatellar
1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.
2. Millard RS. Phys Med Rehabil Clin N Am. 1995;6:841-849.
 5. Local Anesthetic Administration

Anesthesia administration for

the injection site1
Consult prescribing
information for local
anesthetic use Parapatellar
Advance needle as injecting
Learn angle with needle
Approach joint but do not enter
Inject as exiting from skin Ref 1,
p 121H

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.

Suprapatellar/retropatellar
 6. Discuss Postprocedural Care Issues

As anesthesia takes effect, discuss postprocedure instructions1,2

Avoid strenuous or prolonged weight-bearing activities for 48 hours
following injection
Ice can be applied if needed for 20 to 30 minutes up to every 2 hours
while awake
Consider antiinflammatory agent and/or elastic bandage if patient is
prone to effusions
Contact clinician if
Acute joint inflammation
Injection-site redness/discharge
Fever/chills
Take advantage of time to complete
prescriptions, charting
1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.
2. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.
 6. Discuss Postprocedural
Care Issues (contd)

Potential Reaction Frequency Clinical Response

Generally self-limiting
Injection-site pain1 23%
no treatment needed
Rest; avoid strenuous
Local pain and/or swelling of
activities, apply ice, use
the injected joint with or without 1%-13%
NSAIDs; and possibly
effusions1,2
arthrocentesis

Joint infection3 <0.01% Return to clinician

There are no published reports of pseudoseptic reactions

SAIR2,4
for Hyalgan*4

Discontinue use, supportive

Allergic reaction/anaphylactoid2 <1 per million injections
measures if needed

1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.

2. Maheu E, et al. Int J Clin Pract. 2002;56:804-813.
3. Zuber TJ. Am Fam Physician. 2002;66:1497-1500.
4. Goldberg VM, et al. Clin Orthop. 2004;419:130-137.
*Based on a MEDLINE, TOXLINE, EMBASE, International Pharmaceutical Abstracts, and BIOSIS literature searches as of March 2005.
 7. HYALGAN Injection: Aspiration

If visible effusion, aspirate joint fluid

18-gauge needle preferred
Use same angle as with anesthesia
Might feel slight pop as joint
capsule is punctured
Otherwise, no resistance
Aspirate
Remove as much of effusion as Suprapatellar/retropatellar
possible
If aspirate is abnormal, do not inject
HYALGAN
Send fluid for analysis
If unable to aspirate
Reposition needle
Rotate needle bevel (90-180)
Milk fluid
Look for vapor
1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.
Parapatellar
 7. HYALGAN Injection: Syringe Change

Change to injection syringe1

Immobilize needle with
hemostat
Grasp needle at mid hub
(where plastic covers metal)
with clamp
Unclasp aspirating syringe
Attach injectate syringe

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.

7. HYALGAN Injection

Suprapatellar/Retropatellar Parapatellar
 7. HYALGAN Injection:
Injecting HYALGAN

Injecting HYALGAN1
Draw back gently before
injection
Inject steadily
Should be no significant Suprapatellar/retropatellar
resistance

Parapatellar
1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15 (1):117-145.
 8. Immediate Postprocedure Phase

Following HYALGAN injection1

Wipe off Betadine with
gauze
Dry skin with gauze
Apply adhesive bandage
Apply compression for 2 to
5 minutes

1. Stitik TP. Phys Med Rehabil State Art Rev. 2001;15:117-145.

Procedure

1. Prepare materials
2. Position patient
3. Choose injection site
4. Mark and cleanse injection site
5. Local anesthetic administration
6. Discuss postprocedural care issues
7. HYALGAN injection
8. Immediate postprocedure phase
HYALGAN
Important Safety Information

HYALGAN is contraindicated in patients with known

hypersensitivity to hyaluronate preparations. Intra-articular
injections are contraindicated in cases of past and present
infections or skin diseases in the area of the injection site1
The effectiveness of a single treatment cycle of less than 3
injections has not been established1
In the US clinical trial of 495 patients, the only adverse event
showing statistical significance vs placebo was injection-site
pain1

Please see full prescribing information.

1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.
HYALGAN
Important Safety Information

Other adverse events included gastrointestinal complaints,

headache, local ecchymosis and rash, local joint pain and
swelling, and local pruritus. However, the incidence of these
events was similar in the HYALGAN and placebo groups1
In other clinical studies, the frequency and severity of adverse
events occurring during repeat treatment cycles did not increase
over that reported for a single treatment cycle1
Anaphylactoid and allergic reactions have been reported with
this product. In the 2 events reported as anaphylactoid reactions,
HYALGAN treatment was discontinued and both had favorable
outcomes. Three cases of allergic reactions were reported in
which the patients were discontinued from HYALGAN treatment
and the incidents resolved
Please see full prescribing information.
1. HYALGAN [package insert]. New York, NY: sanofi-aventis Group; 2001.