STRYKER EXHIBIT 1003, pg. 1
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`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
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`IPR2014-01433
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`STRYKER EXHIBIT 1003, pg. 1
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`Percutaneous Vertebroplasty
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`H. Deramond, M.D., i“ C. Depriester; i’l/I.D., * P. Tousscrmt, il/I.D., i and P. Galiberi MUD. i"
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`ABSTRACT
`
`Percutaneous vertebroplasty (PVP) with acrylic cement [polymethylmethacrylate
`(PMMA)]consists of injecting PMMA into vertebral bodies weakened by osseous le—
`sions. The aim of PVP with PMMA is to obtain an antalgic effect by consolidation in
`destructive lesions of the spine. There are three major indications: vertebral angiomas,
`osteoporotic vertebral crush syndromes, and malignant vertebral tumors. Indications
`in vertebral angiomas only concern patients with aggressive clinical signs (severe
`pain or nervous compression) and/or aggressive radiological signs. Indications in 03)
`teoporotic vertebral crush syndromes only concern patients suffering from back pain
`related to one or two adjacent vertebral collapses resistant to medical treatment for
`several weeks. Indications in malignant vertebral tumors only concern patients suffer
`ing from severe back pain related to a destruction of the vertebral body, not involving
`the major part of the cortical bone. Complications of PVP occur essentially in patients
`with vertebral metastasis. In the great majority of cases, these complications heal un-
`der medical treatment. In patients with osteoporotic vertebral crush syndromes or verr
`tebral angiomas,
`the complications are represented by the increase or onset of
`radiculalgias (in less than 1%), which disappear after local anesthetic injection.
`
`KEYWORDS: Vertebroplasty; spine; interventional radiology
`
`Percutaneous vertebroplasty (PVP) consists of
`injecting an acrylic cement [polymethylmethacryr
`late (PMMA)]in the vertebral body by a percuta—
`neous route. This procedure was created by the
`authors in 1984.“3 At that time, the aim of the PVP
`
`was to consolidate the vertebral body weakened by
`an aggressive vertebral angioma. Several years later,
`the method was extended to other weakening le-
`sions, such as osteoporotic vertebral crush syn»
`drome, vertebral myeloma, or metastatic vertebral
`lesions.“J The aim of the PVP is to obtain a rapid
`antalgic effect by means of consolidation in painful
`diseases weakening the vertebral body.
`
`METHODS AND MATERIALS
`
`The material needed for PVP includes:
`
`Ten-gauge needles of 10 to 15 cm long with a beve
`elled extremity (these needles are used at the tho-
`racic or lumbar level) ;
`Fifteen-gauge needles of 5 to 7 cm long with a
`tapered tip (these needles are used at the cervi-
`cal level) ;
`Liter—lock syringes of 2 or 3 cc (these syringes
`have to be very resistant);
`A syringe handle to push the PMMA with the
`maximum of efficiency;
`Bone cement—This cement consists of powder
`and liquid components. The principal component
`of liquid bone cement is methylmethacrylate. The
`main component of the powder is polymethyL
`methacrylate. Different types of acrylic cements
`are available. The cement must have a long
`polymerizing time-lag, allowing injections with a
`syringe;
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`
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`*De )artnlents of Radiolo ' and lNeurosur er r, University Hos ital, Amiens. France
`I
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`Reprint requests: Dr. Deramond, Department of Radiology, University Hospital, Aniiens, France
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`Copyright © 1997 by 'I‘hicme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001. All
`rights reserved.
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`Figure 1.
`jection.
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`CS vertebral metastasis. A. CS antero-lateral approach with a 15-gauge needle; B. After PMMA in—
`
`
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`O Tantalum powder is added to the polymethyl—
`methacrylate powder to obtain a good radiopacity
`of the cement: The radiopacity of barium sulfate is
`not sufficient when using fluoroscopic control.2v3
`
`TECHNIQUEZJJW
`
`PVP can be performed under local anesthesia,
`neuroleptanalgesia, or general anesthesia. At the
`cervical
`level, an anterolateral approach of the
`vertebral body is achieved with a 15—gauge needle
`(Fig. 1). At the thoracic or lumbar levels, the ap—
`proach is posterolateral: A transpedicular approach
`to the vertebral body is preferable (Figs. 2—4)
`to
`avoid cement leakage into the intervertebral fora-
`mina (Fig. BB and C).
`The patient is placed in a supine position for a
`cervical PVP and in a prone position for a thoracic
`or lumbar PVP.
`
`ln focal osteolytic lesions, the needle has to be
`inserted in the center of the tumor. In lesions con—
`
`the needle is
`cerning the whole vertebral body,
`placed in the superior or inferior part of each verto
`bra] half. It is recommended to avoid the middle
`
`third of the vertebral body so as to prevent a rapid
`passage of the cement
`into the large vertebral
`draining veins. In focal tumoral osteolytic lesions
`(metastasis and myeloma), another needle will be
`inserted in the part of the vertebral body that is ap-
`parently architecturally normal. Finally, in the ma-
`jority of cases, PVP is performed using two needles:
`one in each vertebral half. The first injection of
`PMMA will allow one to better appreciate the need
`for a second injection in the contralateral vertebral
`half and the optimal needle placement (Fig. 4}.
`Once the needle is in good position in the ver—
`tebral body, the PMMA can be injected. The PMMA
`
`
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`T—11 Vertebral angioma responsible for back pain. Transpedicular approach of the right vertebral
`Figure 2.
`body: A. AP view; B. lateral view; (Figure continued on the next page.)
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`(Continued). C. CT scan control af-
`Figure 2.
`ter PVP with PMMA.
`
`powder bag is opened and a part of its content is
`emptied into a 20-th syringe. The 20 ce’s of PMMA
`powder are carefully measured and poured into a
`dry and sterile mixing bowl. One gram of tantalum
`powder is then added to the PMMA powder and
`mixed. The ainpoule containing the liquid 1110110-
`mer is opened and 5 cc are measured and added to
`the powder in the mixing bowl. The mixture is
`slowly spatulated for 1*? min and left for de—aera—
`
`tion for about 1 min. The mixture is then trans-
`
`ferred into a IU-cc syringe, and then into 3 luer—lock
`syringes of 2 and 5 cc’s. When the mixture reaches
`the consistency of a toothpaste, the cement is intro-
`duced into the vertebral body under lateral fluoro—
`scopic guidance. Once the cement
`injection is
`achieved,
`the needle is slowly pulled back to the
`cortical bone while pushing the mandred into the
`needle. The needle is then turned to and fro during 7
`
`
`
`
`
`Flgure 3. Paras-aresis related to a T—7 aggressive vertebral angioma. A—B. Axial CT scan and sagittal T1-
`weighted MRI after intravenous injection of contrast media. Epidural component of the angioma with compression of
`the spinal cord. (Figure continued on the next page.)
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`(Continued). 0. PVP performed through a right postero~lateral approach with a 10-gauge needle
`Figure 3.
`under CT scan control (arrow head) and injection of PMMA (star). At the same time, a left postero—lateral approach
`with an 18-gauge needle in the remaining part of the vertebral body (arrow) not injected with PMMA and in the
`angiomatous posterior neural arch will be performed and glue will be injected. D. CT scan control after laminectomy
`and epidural angiomatous component excision. PMMA (star). Glue (Histoacry® + Lipiodol) (arrow),
`l
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`the polymerization time-lag to avoid it gluing with
`the cement, then pulled back without any leakage.
`If needed, a second needle is placed in the con—
`tralateral part of the vertebral body and the proce—
`dure is repeated.
`A major point is to carry out the injection un-
`der lateral fluoroscopic guidance because of the
`
`radiopacity of the cement secondary to tantalum
`powder. The injection has to be stopped as soon
`as the cement reaches the vertebral posterior cor-
`tex, or in case of a perivertebral venous injec-
`tion. PVP may also be carried out under combined
`computed tomography (CT) and fluoroscopy guid—
`ance.‘0
`
`
`
`Figure 4. Osteoporotic vertebral collapse of
`L1. L1 vertebral collapse. A. Lateral View. Left
`transpedicular approach with a 10—gauge needle us-
`ing a coaxial technique (arrow) and vertebral biopsy
`with a 15-gauge needle. (Figure continued on the
`next page.)
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`(Continued). 3, C. AP and lateral View. Left transpedicular approach with the 10-gauge needle in
`Figure 4.
`position before the injection of PMMA. D. AP View after the injection of PMMA in the left part of U. E. AP View after
`contralateral puncture of L1 through a right transpedicular approach. (Figure continued on the next page.)
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`(Continued). F—H. X-ray control af—
`Figure 4.
`ter PVP. AP (F) and lateral views (G). Axial CT scan
`(H).
`
`INDICATIONS AND RESULTS
`
`I’VP was primarily indicated in vertebral an—
`gioinas.1-3 Later, the indications were extended to
`other conditions which weaken the vertebral body,
`particularly osteoporotic vei'teb ‘al crush syndrome
`and malignant osteolytic lesions (metastasis and
`niyelornas) .H‘
`
`VERTEBRAL ANGIOMAS
`
`Vertebral angionlas are asymptomatic lesions
`in most cases. On plains films, vertebral angionias
`are Characterized by an irregular and vertical trar
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`they contain a focal, well~
`bcculation. On CT,
`circumscribed hypodense fatty density with a little
`increase in density after an intravenous injection of
`contrast media. 011 magnetic resonance ima‘tgfingr
`(MRI), they appear as a focal, well—circurnscribed le-
`sion, hyperintense on rl'lit-veighted images with a
`mild signal enhancement after intravenous injec-
`tion of gadolininmfi They rarely become symp-
`tomatic and painful. The indication of PVP only
`concerns aggressive vertebral angiomas. This ag~
`gl‘essivcness may be either clinical or radiological. A
`clinically aggressive vertebral angioma is a symp—
`tomatic lesion giving intense racl'iialgias or new
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`gioma gives specific signs: (I) the whole vertebra is
`involved; (2) the lesion exhibits low signal intensity
`on Tl-weighted images on MRI and iso-density on
`(IT with an intense enhancement after intravenous
`
`injection of contrast media; (3) there is a periver-
`tebral
`invasion with an epidural extension and
`compression of the spinal cord or nerve roots (Fig.
`3A and B); (4) sometimes a vertebral collapse may
`occur.“'
`
`In painful vertebral angiomas without signs of
`radiological aggressiveness, PVP is an excellent al-
`ternative to irradiation or to transarterial emboliza—
`
`tion.g More than 40 patients have be treated in our
`institution with a follow-up of 3 to 10 years. A com-
`plete an talgic effort was obtained in all patients but
`two (Fig. 2).
`Indications of treatment in aggressive angio-
`mas depends on the clinical signs and symptoms:
`
`0 When clinical symptoms consist only of intense
`back pain without neurological signs, we perform
`PVPS’L12 An annual
`follow—up of the patient
`(checking for the absence of clinical signs recur-
`rence) is needed. We have never been faced with
`a secondary evolution of the vertebral angioma.
`0 In cases presenting with nerve root or spinal cord
`compression of slow onset, and a radiological ex~
`amination showing an epidural component, PVP
`is completed during the same procedure by a
`puncture of the remaining part of the vertebral
`angioma not injected with cement, and injection
`of absolute alcohol (2 to 6 cc) or Ethibloc® to ob-
`tain a consolidation and sclerosis of the an-
`
`gioma.12“3 “7e have treated 5 such cases. None
`had a recurrence of the vertebral angioma. In all
`cases, neurological signs slowly disappeared. Back
`pain persisted in only one case.
`0 In patients presenting with neurological signs
`and an aggressive vertebral angioma with a huge
`epidural extension (Fig. 3), the aim of the treat-
`ment. is to obtain consolidation ofthe spine and de-
`compression of the spinal cord and nerve roots.
`The treatment is then conducted in two stepsflg-H'15
`The first step is a percutaneous treatment on Day
`1 and the second step a surgical excision on Day
`2. The percutaneous treatment consists of a PVP
`strictly limited to the vertebral body. In the same
`procedure, a percutaneous puncture of a verte-
`bral body site is performed using an lS—gauge
`needle. An injection of contrast media with lat
`eral and anterior~posterior serial
`radiographs
`checks for the correct position of the needle as
`well as opacification of the epidural extension.
`The local injection of a mixture of tissue glue
`(Histoac1yl®) and lipiodol is then done under
`fluoroscopic control. If necessary, the same pro-
`
`the neural arch is also injected with
`angioma,
`Histoacryl® after one or several percutaneous
`punctures. It is possible to use another emboliza—
`tion agent. (alcohol or Ethibloc®) instead of His-
`toacry1®but,
`in such cases, we personally prefer
`the use of tissue glue. On Day 2, the surgical exci—
`sion of the lamina and epidural part of the an-
`gioma is carried out and greatly facilitated by the
`percutaneous treatment. PVP gives a good con—
`solidation of the vertebral body weakened by the
`vertebral angiorna. Three patients have been
`treated with success and are still asymptomatic at
`
`longvterm follow-up (Fig. 3).
`
`OSTEOPOROTIC VERTEBRAL
`CRUSH FRACTURE SYNDROME
`
`One third of women over 65 have ari osteo—
`porotic vertebral fracture during the rest of their
`life, either spontaneously or after a minimal trauma.
`These fractures are often painful and the treatment
`consists of immobilization, analgesic drugs, and spe—
`cific treatment of osteoporosis. The majority of
`patients improve rapidly with such treatments.
`Sometimes persistent pain induces prolonged bed-
`rest, which increases demineralization and the risk
`of clinical decubitus complications. In that situa
`tion, if a persistently incapacitating and focal back
`pain is related to one, two, or three adjacent verte—
`bral collapses, PVP is an excellent treatmentT'J'llj
`(Fig. 4).
`In our experience, 40 patients were treated
`with rapid and complete relief of pain in more than
`90% of the cases. Two adjacent vertebra were in“
`jected in 14 patients. Three adjacent vertebral were
`injected in 4 patients. The patients were able to
`stand up and walk 24 hr after PVP. The antalgic
`effect was prolonged as proved by a long-term fol-
`low—up. The collapse of a vertebra adjacent to the
`one injected with PMMA is a risk after I’VE”) In our
`opinion, the risk of adjacent collapse is low and may
`also occur in any patient at all vertebral levels dur-
`ing the follow—up of osteoporotic disease.
`There was one complication in our experience:
`a radiculalgia that healed after local anesthetic in—
`jection (Fig. 5). In the majority of cases, a bone
`biopsy was performed during the PVP before the
`cement injection to eliminate a nonosteoporotic
`vertebral collapse (Fig. 4A).
`
`PVP AND MALIGNANT SPINAL TUMORS
`
`Bone metastases occur in 30 to 70% ofpatients
`with cancer. The spine is frequently affected by
`bone metastases. Spinal pain represents the major
`symptom in more than 70% of affected patients.
`One of the major factors of spinal pain is mechani-
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` RADIOLOGY VOLUME 1, NUMBER 2
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`Figure 5. Osteoporotlc vertebral crush syn-
`drome. A. AP view. Right postero-lateral approach
`after injection of PMMA in the left hemivertebra
`(star). 8. AP view after injection of PMMA into the
`whole vertebral body. Leakage of PMMA along the
`needle track (arrow). C. Axial CT scan after PVP.
`Leakage of PMMA along the needle track responsi-
`ble for intercostal neuralgia.
`
`cal. PVP is based on the hypothesis that the consoli-
`dation of weakened and tumoral vertebral bodies
`will significantly lessen the pain. Indications for
`PVP are metastatic or myelomatous localization in
`the vertebral body. The best indications concern pa-
`tients complaining of an intense, focal and mechan-
`ical back pain, requiring bedrest and major antalgic
`drugs, related to a malignant tumoral vertebral col-
`lapse without epidural involvement. In such cases,
`an important antalgic effect, allowing the patient to
`stand up, is obtained 24 to 48 hr after the proce-
`dure in more than 70% of the patients}?22 (Fig. 6).
`Where do indications of PVP stand as opposed
`to radiation therapy? PVP and radiation therapy are
`complementary treatment-s. PVP must precede
`irradiation. PVP induces a rapid antalgic effect;
`irradiation then increases this effect with an anti-
`tumoral complementary action. The effects of irra—
`
`diation are not affected by PVP. It is postsible to per-
`form PVP on a previously irradiated vertebral seg-
`mentissveleassei
`
`What are the indications for PVP as opposed
`to surgeiy? The indications of PVP and surgery
`are different. PVP is a palliative method in patients
`with a localized vertebral body destruction, without
`epidural involvement. An association of PVP and
`surgery is indicated if PVP facilitates the surgery
`and helps in obtaining vertebral body consolida-
`tionJSs22
`
`Must the posterior cortex of the vertebral body
`be intact before the PVP? In our experience, more
`than 50% of patients treated by PVP presented
`some degree of destruction of the posterior cortex
`of the vertebral body. In the absence of spinal cord
`compression or epidural involvement by the tumor,
`it is possible to perform PVPJ'F‘IBE?
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`Figure 6. T5 vertebral metastasis. A. Axial CT: partial osteolysis of the vertebral body and of the right part of
`the vertebral posterior cortex. B. Sagittal T2 MRI. 0, D. Plain film AP view and CT scan after PMMA injection through
`a bilateral transpedicular approach.
`
`In cases of an osteolysis with a high risk of ver—
`tebral collapse, it is recommended in an asympw
`toniatic metastatic vertebral body lesion to perform
`PVP to prevent vertebral collapse. A complemen-
`tary irradiation can be carried 0111.15
`PVP is rarely necessary at the cervical and cer—
`vice-thoracic junction level, but can be indicated in
`cases of surgical contraindication.
`
`INCIDENTS AND COMPLICATIONS
`
`Incidents and complications can be related to
`the pereutaneous approach, the status of the pa-
`tients, and the extravasation of PMMA. Together
`with Chirasfifi we reported the incidents and com—
`plications encountered in a series of 258 patients
`treated with PVP. They are detailed below.
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`the PVP occurred in an imrnunocompromised pa
`tient with breast cancer metastases. A 3 months, an-
`tibiotherapy healed the infectious process. Since
`that episode, we decided to perform prophylactic
`antibiotic therapy during the PVP in immunocom-
`promised patients.
`
`COMPLICATIONS DUE TO THE PATIENT STATUS
`
`General complications led to the death of two
`patients with cancer and vertebral metastases: one
`pulmonary embolism that occurred several days af-
`ter the PVP in a bedridden patient and a pulmonary
`infection, which started several days after the PVP.
`The responsibility of PVP is not clearly established
`in these two deaths. Both cases concerned fragile
`patients with cancer and metastatic disease.
`
`LEAKAGE OF PMM’A
`
`Most of these PMMA leakages have no clinical
`consequences. Three types ofleakages can be seen:
`(1) venous leakages can occur in perivertebral or
`epidural veins;
`(2) softetissue leakages can occur
`around the spine, in the epidural space, or along
`the needle track; and (3) discal leakages. The peri—
`vertebral venous leakages were never symptomatic.
`Epidural venous leakages were noticed in more
`than 10% of the procedures. They were symptoe
`malic in 3% of the patients (onset of radicular pain).
`PMMA leakages located laterally in the prever-
`tebral soft tissue were never symptomatic. When the
`leakage occurs along the needle track, the risk of
`radicular pain is possible (1% of patients) (Fig. 5).
`To decrease this risk, we now perform, when possi-
`ble, a transpedicular approach at the thoracic and
`lumbar level. When the leakage occurs in the epidu—
`ral space or in the intervertebral foramina, there is
`a high risk of nerve root or spinal cord compres
`sion. To avoid these complications, PMMA injection
`must be performed under lateral fluoroscopic con-
`trol. The PMMA injection must be handled with
`special care in cases with destruction of the poste-
`rior vertebral cortex. Leakages into the interverte—
`bral disc, from an intravertebral disc herniation, is
`frequent and always asymptomatic. We can decrease
`this risk by inserting the needle into the lateral part
`of the vertebral body.
`
`CLINICAL MANIFESTATIONS INDUCED BY PVP
`
`The clinical manifestations induced by PVP in—
`clude onset or increase of back pain and increase or
`onset of a compression of the spinal cord or nerve
`roots. The increase of back pain was noticed in
`three patients with vertebral metastasis. The exact
`
`294
`
`The increase or onset of radiculalgias is related
`to a PMMA leakage along the needle track, in the
`foraminal veins, or the foraminai space with com-
`pression of the corresponding nerve root. This
`complication occurred in 4% of the patients. Local
`anesthetic injection or medical treatment is effec—
`tive in the majority of patients. Surgical decompress
`sion was necessary in three patients (1%) in which
`PW was indicated for vertebral metastasis. An in—
`crease of the spinal cord compression occurred in
`one patient with a large destruction of the vertebral
`body posterior cortex with tumoral involvement of
`the epidural space. In this case, PVP was indicated
`for vertebral stabilization and to facilitate surgely.
`The patient was urgently operated on and recov—
`ered from his neurological deficit.
`‘
`All of those clinical complications occurred essen~
`tially in patients with vertebral metastasis. We observed
`only one case of radiculopathy, which healed with
`local anesthetic injection, among the patients with os~
`teoporotic vertebral crush syndrome (72 patients).
`Two cases of radiculopathy, which healed after
`local anesthetic injection (once) or ethanol injec-
`tion (once) occurred in patients with vertebral
`angioma (78 patients).
`
`CONCLUSION
`
`is a treatment for back pain related to
`PVl’
`weakening lesions of the vertebral body. The aim of
`the procedure is to obtain an antalgic effect by con-
`solidation of the vertebral body. There are three
`major indications:
`(1) aggressive vertebral angio-
`mas, (2) osteoporotic vertebral crush syndrome, and
`(3) vertebral malignant tumors.
`Indications are the results of multidisciplinary
`discussions. Complications are lessened by a careful
`operative technique, especially good lateral fluoro—
`scopic control during PMMA injection, and accu-
`rate indications.
`
`REFEREN CES
`
`]. Galibcrt P. Deramond H, Rosat P, Lt: Cars D. Note prélimii
`naire sur le traitement dcs angiomes rertébraux par verte—
`broplastie acrylique perculanée. Ncurochirurgie l987;23?i:
`166—168
`
`2. Darrason l". Piace dc Ia vertébroplastic percutanée acryliquc
`dans le traitement des luhnangiomcs vertébraux agressifs.
`These pour le Doctoral en Me‘decine. Université de Pi~
`cat-die; U.E.R. de Médecinc d'Ainiens, 26 October 1988
`3. Deraniond H, Darrason R. Galibert P. La vm'tebroplaslic pet1
`culanée acrylique clans lc traitelnent des btu‘nangitnnes
`vertéhraux agressifs. Rachis 1989;]:143—153
`
`STRYKER EXHIBIT 1003. pg. 11
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`U1
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`f1
`
`1988: 169:372
`Deramond H, Calibert P, Debussche C, Pruvo JP, lleleg A,
`Hodes JE Percutaneous verlebroplasty with methyl-
`methactylate: Technique, metl'lod, results (abstract). Rae
`diology 1990;177:352
`P. La
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`STRYKER EXHIBIT 1003. pg. 12
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`STRYKER EXHIBIT 1003, pg. 12
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`STRYKER EXHIBIT 1003, pg. 12
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`SEMINARS IN MUSCULOSKELETAL RADIOLOGY VOLUME 1, NUMBER 2 1997
`
`Percutaneous Vertebroplasty
`H. Deramond, M.D., * C. Depriester, M.D., * f? Toussaint, M.D., f and f? Galibert M.D.
`
`ABSTRACT
`
`Percutaneous vertebroplasty (PVP) with acrylic cement [polymethylmethacrylate
`(PMMA)]consists of injecting PMMA into vertebral bodies weakened by osseous le-
`sions. The aim of PVP with PMMA i s to obtain an antalgic effect by consolidation in
`destructive lesions of the spine. There are three major indications: vertebral angiomas,
`osteoporotic vertebral crush syndromes, and malignant vertebral tumors. lndications
`in vertebral angiomas only concern patients with aggressive clinical signs (severe
`pain or nervous compression) and/or aggressive radiological signs. lndications in os-
`teoporotic vertebral crush syndromes only concern patients suffering from back pain
`related to one or two adjacent vertebral collapses resistant to medical treatment for
`several weeks. lndications in malignant vertebral tumors only concern patients suffer-
`ing from severe back pain related to a destruction of the vertebral body, not involving
`the major part of the cortical bone. Complications of PVP occur essentially in patients
`with vertebral metastasis. In the great majority of cases, these complications heal un-
`der medical treatment. In patients with osteoporotic vertebral crush syndromes or ver-
`tebral angiomas, the complications are represented by the increase or onset of
`radiculalgias (in less than 1 %), which disappear after local anesthetic injection.
`
`KEYWORDS: Vertebroplasty; spine; interventional radiology
`
`Percutaneous vertebroplasty (PW) consists of
`injecting an acrylic cement [polymethylmethacry-
`late (PMMA)]in the vertebral body by a percuta-
`neous route. This procedure was created by the
`authors in 1984.1-3 At that time, the aim of the PVP
`was to consolidate the vertebral body weakened by
`an aggressive vertebral angioma. Several years later,
`the method was extended to other weakening le-
`sions, such as osteoporotic vertebral crush syn-
`drome, vertebral myeloma, or metastatic vertebral
`lesions.@ The aim of the PVP is to obtain a rapid
`antalgic effect by means of consolidation in painful
`diseases weakening the vertebral body.
`
`METHODS AND MA-
`
`The material needed for PVP includes:
`
`Ten-gauge needles of 10 to 15 cm long with a bev-
`elled extremity (these needles are used at the tho-
`racic or lumbar level);
`Fifteen-gauge needles of 5 to 7 cm long with a
`tapered tip (these needles are used at the cervi-
`cal level);
`Luer-lock syringes of 2 or 3 cc (these syringes
`have to be very resistant);
`A syringe handle to push the PMMA with the
`maximum of efficiency;
`Bone cement-This
`cement consists of powder
`and liquid components. The principal component
`of liquid bone cement is methylmethacrylate. The
`main component of the powder is polymethyl-
`methacrylate. Different types of acrylic cements
`are available. The cement must have a long
`polymerizing time-lag, allowing injections with a
`syringe;
`
`"Departments of Radiology and tNeurosurgery, University Hospital, Amiens, France
`
`Reprint requests: Dr. Deramond, Department of Radiology, University Hospital, Amiens, France
`
`Copyright O 1997 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001. All
`rights reserved.
`
`STRYKER EXHIBIT 1003, pg. 13
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`SEMISARS I N h,fUSCULOSKEI ,F,T1411 RADIO1 ,OGY VOLU MF. 1 , NUMBER 2
`
`7 997
`
`A
`
`Figure 1. C5 vertebral metastasis. A. C5 antero-lateral approach with a 15-gauge needle; 6. After PMMA in-
`jection.
`
`'Ihntalum powder is added to the polyme~hyl-
`methacrylate powder to obtain a good radiopacity
`of ~ h c cement: The radiopacity or barium sulfate is
`not sufficient when using iluoroscopic cor~trol.'.:~
`
`P\T
`can be perforrned under local anesthesia,
`neuroleptanalgesia, or gcrleral anesthesia. At the
`cervical levcl, an anterolatcral approach of the
`vertebral body is achieved with a 15-gauge needle
`(Fig. 1). At the thoracic or lumbar levels, the ap-
`proach is posterolateral: A transpediculal- approach
`to the vertebral body is preferable (Figs. 2-4) to
`avoid cement leakage into the irltcrvet-tebral lol-a-
`rnirla (Fig. 5 B and CJ .
`The patient is placed i r l a supine positior~ for a
`cervical PVP and in a prone position for a thoracic
`or lurribar PW.
`
`In focal osteolytic lesions, the needle has to be
`irlserted in 11.1~ center or the tumor. I11 lesioris con-
`cerning the whole vertebral body, the needle is
`placed in the superior or infer-ior part of' each vertc-
`bra1 half'. It is recorr~rnended to avoid the middle
`third of the vertebral body so as to prevent a rapid
`passage of the cement into the large vertebral
`tiraining veins. In focal turnoral osteolytic 1r:sions
`(metastasis and myeloma), arlot.her needle will be
`inserted in the part of the vertebral body that is ap-
`parently architecturally riormal. Finally, in the ma-
`jority of cases, PVP is pe