OSTEOFLEX RADIOPAQUE BONE CEMENT FOR

INTERVENTIONAL RADIOLOGY # ENDOSCOPY # VASCULAR # SPINE
OSTEOFLEX RADIOPAQUE BONE CEMENT FOR
VERTEBROPLASTY AND KYPHOPLASTY
CLINICAL REPORT
INTRODUCTIO
N
2 Year Period
35
32
• Treatment carried out over a 2-year period
• 50 patients (32 women and 18 men), mean age 61.8, were treated
at 58 vertebral segment levels with the intention to relieve pain
related to vertebral body lesion, into 24 thoracic, 32 lumbar and 2
cervical vertebrae, under fluoroscopic guidance.
• It has been shown that a few quantity of bone cement (between 2
and 6ml) is most of the time enough to obtain pain relieve in
vertebral osteoporosis or tumoral fractures.
• Bone cement formulation offers better adapted procedure to the
technique
• OSTEOFLEX® bone cement is low exothermic bone cement
for vertebroplasty with a medium viscosity which allows a
comfortable and secure application.
NUMBER OF PATIENTS
30
25
18
20
15
10
5
0
Women
Men
GENDER
MATERIALS
AND METHODS
Patients were enrolled in the study according to the inclusion
criteria:
• Osteoporosis compression fractures
• Primary tumors or metastatic localisation
• Not more than 3 levels involvement
All of the patients had vertebral fracture, all of them suffered from a
persistent high level of pain despite the medical treatment.
All the procedures were performed under local anaesthesia and
sedation except in 16 patients, in prone position of the patient with
imaging control using mostly biplane fluoroscopic guidance.
Diagnosis
PRINCIPAL
INDICATIONS
Sex
Men
Women
Osteoporosis
Primary tumor
2
Lung metastasis
Others
Total
Lumbar
Total
1
3
7
10
4
Lymphoma
Thoracic
16
10
Kidney metastasis
Cervical
16
7
Breast vertebra metastasis
Localisation
Total
Sex
4
7
8
15
2
1
3
22
36
58
Men
Women
Total
1
1
2
7
15
22
11
23
34
19
39
58
TRANSPEDICULAR
APPROACH
Except in 13 patients, all the control of the percutaneous procedure
was performed by visualisation with fluoroscopy.
Percutaneous approach was made under sterile conditions with
special bevelled Luer-lock needles of 11 and 13 gauge, 12.5cm length.
Introduction of the needle was performed by transpedicular
approach.
13 G
A special biopsy needle ready to use, allow performing by a simple
gesture a bone biopsy.
11G
CEMENT
Osteoflex® is a special cement that was developed for this
indication with many advantages according to the entire request to
this procedure.
Low exothermic polymethyl methacrylate bone cement charged
with high concentration of contrast agent.
This allows a good visualization of the cement during filling of the
vertebral body.
The viscosity and setting time of this cement have been specifically
designed for vertebroplasty applications.
Picture 1
Before surgery
80%
RESULTS
70%
60%
50%
40%
30%
At 12-24 hours, patients were seen and asked to subjectively report
their pain as being improved, unchanged, or worse than before the
procedure.
20%
10%
0%
Before surgery
Before surgery Disabled (80%) Severe (22%) Moderate (5%)
Functional
matter
Disabled
Severe
Moderate
After surgery None – no remaining pain (83%) Mild (15%)
After surgery
Functional matter at the beginning 96% of patients were in bad
state: Disabled (35%) Severe (55%) moderated (5%)
After the surgery 100% of these patients recover a comfortable
functional state as follows: Normal (80%) Mild (20%)
80% of all the patients were able to stop the medication for their
pain, 20% of all the patients were able to decrease the amount of
oral pain medication that they required on a daily basis.
80%
60%
40%
20%
0%
After surgery
Functional matter
No pain/normal
Mild
SAFETY
No major complications occurred in all the patients
Leakage was detected in 25 patients
- 2 anterior and 2 small posterior leakages
- 5 local venous leaks
- 1 leak in soft tissue
There were no consequences of these leakages
Recommendation that the injection of the cement at 4 minutes
At the end of the second year we did not detect a new vertebral
fracture in these patients
We can suggest that vertebroplasty can prevent the progression of
vertebral collapse at the level of the treated vertebrae.
DISCUSSION
This study demonstrated that percutaneous injection of
OSTEOFLEX® for treatment of refractory pain resulting from
osteoporosis, (16 patients), primitive tumor (3 patients) vertebral
fractures, Lymphoma (15 patients), metastasis vertebral fractures (24
patients), rapidly produces significant pain relief and improves
mobility.
Our study shows that this rapid analgesic effect is persistent.
The clinical result was very good.
Results reproduced published data and we can recommend use of
vertebroplasty for painful vertebral lesions.
CONCLUSION
Vertebroplasty is very efficient for pain treatment. As we have shown
in our study, this procedure restores patient mobility and provides
immediate and extended pain relief of symptomatic vertebral body
fractures.
Complications were mostly related to excessive PMMA injection, so,
in this study, the physicians were conscious to use just the necessary
quantity of cement.
THE END
BEFORE
CLINICAL
CASE
Case 1:
Cervical vertebroplasty
Lung metastasis
AFTER
LATERAL APPROACH
COMPLETE FILLING OF THE LESION
CLINICAL
CASE
Case 2:
Woman 60 years
Breast metastasis
BEFORE
AFTER
CLINICAL
CASE
Case 3:
Man 68 years
L1: Myeloma
BEFORE
AFTER
BEFORE
CLINICAL
CASE
Case 4:
Man 70 years
Myeloma L1 – L2
AFTER
BEFORE
CLINICAL
CASE
Case 5:
Woman 59 years
Gynaecologic metastasis
Vertebroplasty of L3
AFTER
BEFORE
CLINICAL
CASE
Case 6:
Man 60 years
L3 Lung metastasis
AFTER
BEFORE
CLINICAL
CASE
Case 7:
Man 65 years
T4: Lung metastasis
DOUBLE APPROACH
COMPLETE FILLING
BEFORE
AFTER
CLINICAL
CASE
Case 8:
Woman 63 Years
Breast metastasis
AFTER
Vertebroplasty of T12
Good filling of the vertebra
SAFETY
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2. Lapras C, Mottolese C, Deruty R, Remon J, Duquesnel J. Injection percutanée de méthylmétacrylate dans le
traitement de l’ostéoporose et l’ostéolyse vértébrale grave. Am Chir 1989 ;43 :371-6
3. Cyteval C, Sarrabere MP, Roux JO, Thomas E, Jorgensen C, Blotman F et al. Acute osteoporotic vertebral collaps :
open study on percutaneous injection of acrylic surgical cement in 20 patients. AJR Am J Roentgenol 1999; 173:168590
4. Kaemmerlen P, Thiesse P, Jonas P, Duquesnel J, Bascoulergue Y, Larras C. Percutaneous injection of orthopedic cement
in metastasis vertebral lesion. N Engl J Med 1989;321:121
5. Cortet B, Cotten A, Boutry N, Dewatre F, Flipo RM, Duquesnoy B. Percutaneous vertebroplasty in patients with
osteolitic metastases or multiples myeloma. Rev Rhum Engl Ed 1997;64:177-83
6. Treatment of painful compression vertebral fracture with vertebroplasty: results and complications.( II trattamonto
delle fratture vertebrali dolorose con vertebroplastica: Risultati e complicanze); Giovani Carlo Anselmetti, Andrea
Corginier, Felicio Debernardi, Daniele Regge; Instituto per la Ricerca e la cura del cancro Candiolo (Torino) Italy
Dr J. Palussiere, Bergonié Institute of Cancer. Bordeaux - France
Dr Richard Aziza, Oncoloy Institut Claudius Regaud of Toulouse. France
Dr N. Sahraoui Clinical department Teknimed, Toulouse, France
Pan Medical Ltd
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