Interventional Spine

Sean, M, Tutton, MD
Mark, Davidian, MD, Non ASSR Member
Frank, Facchini, MD, Non ASSR Member
Charles, Nutting, MD, Non ASSR Member
Orlando, Ortiz, MD, Non ASSR Member
Dan, Nguyen, MD, Non ASSR Member

Paper/Non-Mentor

Purpose

It is well known in the Vertebral Compression Fracture (VCF) literature that 10-15% of osteoporotic vertebrae have areas of sclerotic or compact bone resulting in unpredictable cement flow and potential leakage. A novel cavity creating device has been designed to core single or multiple helical bone channels through bone. The Blazer(Blazer Vertebral Augmentation System; Benvenue Medical, Inc.)has the ability to penetrate through hard bone and direct cement flow. We report on our experience with this device in 31 patients and 39 levels

Methods & Materials

Multi-center retrospective analysis of the first 31 patient procedures was preformed evaluating technical success in creating a curvilinear bone channel, predictable cement flow, and complications. Cement flow pattern and presence of extravasation, were specifically evaluated.

Results

Multiple curvilinear vertebral channels were confidently created from a unipedicular lateral position in the VB. Cement flow followed the bone channels allowing targeted cement delivery with potentially better interdigitation compared to balloon assisted systems. Cement fill from endplate to endplate, and crossing midline was consistently achieved with cement extravasation (31%) in line with the published vertebroplasty literature in this most challenging subgroup of the VCF population

Conclusion

Our preliminary experience suggests that this novel cavity-creating device may be useful when sclerotic or compact bone is encountered during unipedicular vertebral access for VA. The novel channels appear to afford better targeted cement delivery from endplate to endplate,and across midline with acceptable rates of cement extravasation, and overall complications.

References/Financial Disclosures

Sean Tutton is a consultant for Benvenue Medical
Dr. Ortiz is consultant for Orthovita
Frank Facchini is a consultant for Navilyst
Charles Nutting is consulant for Navilyst

Interventional Spine

STEFANO, MARCIA, MD
STEFANO, MARINI, MD, Non ASSR Member
EMANUELE, PIRAS, MD, Non ASSR Member
MARIANGELA, MARRAS, MD, Non ASSR Member
GIORGIO, MALLARINI, PROF, Non ASSR Member

Paper/Non-Mentor

Purpose

the aim to study was to evaluate the effectiveness of nitinol endovertebral implant assisted vertebroplasty in the treatment of ostheoporotic vertebral fractures by means of pain reduction and height reastauration.

Methods & Materials

from February to May 2010 ten consecutive patients (3 male, 7 female, average age: 69,7) with painful ostheoporotic vertebral fractures underwent nitinol endovertebral implant assisted vertebroplasty(VerteLift®, SpineAlign Medical, USA). Patients had been previously evaluated with clinical examination and with X-Ray, CTms and MRI T2w STIR. All the procedures were executed with local anaesthesia with bilateral approach under digital fluoroscopic guidance. After the working cannulas were inserted, two Nitinol endoprosthesis (16 or 18mm, symmetric or asymmetric) were expanded within the vertebral body; bone cement (PMMA) was then injected under fluoroscopic control. A total of 12 vertebras was treated. Clinical evaluation, assessment of pain by mean of a11-points visual analogue scale (VAS, 0-10) and of function by means of the Oswestry disability scale(ODI 0-100%) was performed at baseline and at one month after the procedure. Height restauration by mean of volume calculation with CTms was made before and after the procedure.

Results

we have obtained a progressive reduction of the pain in all the patients (Av. VAS pre: 7.8, post 3.0, difference: 4.7), an improvement of function(ODI baseline: 50.6%, at 1M: 24.4%, difference: 26.2%) a good restoring of the height (Av. h pre: 217mm, post: 200mm, difference: 17mm), and a good increasing of the volume of the vertebral bodies (Av. V pre: 26.9cm3, post: 24.6cm3, difference: 3.3cm3). No complications arose, neither device migration was noted.

Conclusion

from our preliminary studies the implant of VerteLift® resulted to be safe and effective in the treatment of painful ostheoporotic vertebral fractures.

References/Financial Disclosures

Consultant of SpineAlign

Interventional Spine

Amanjit, S, Baadh, MD
Ritu, Bordia, MBBS, Non ASSR Member
Orlando, Ortiz, MD, MBA, Non ASSR Member

Paper/Non-Mentor

Purpose

To determine the incidence of prior osteoporosis evaluation and management in patients presenting with painful osteoporotic vertebral compression fractures (oVCFâ

Interventional Spine

Orlando, Ortiz, MD, MBA
Amanjit, Baadh, MD, Non ASSR Member
Ritu, Bordia, MBBS, Non ASSR Member

Paper/Non-Mentor

Purpose

To determine the incidence and causative factors of a subsequent VCF in patients who have had previous vertebral augmentation for their osteoporotic VCF.

Methods & Materials

Medical records were reviewed retrospectively for all patients who underwent vertebral augmentation procedures for treatment of VCFs from October 2000 to April 2009. Patients who sustained a repeat VCF after initial fracture and treatment with vertebral augmentation were identified and the underlying cause or associated factor involved in the incident fracture noted. Underlying causes and associated factors were identified as trauma or fall, no osteoporosis treatment or failed treatment compliance, no post procedure physical therapy, failure to follow safe movement guidelines, steroid dependent osteoporosis, underlying multiple myeloma and no cause found.

Results

Out of the 439 patients included in this study, 346 were female and 93 were male. The mean age of these patients was 76.9 years (age range – 25 to 95 years). We found that 59 (13.4%) of these patients suffered a repeat VCF after their initial fracture had been treated with vertebral augmentation. As some patients suffered multiple repeat fractures the total number of repeat fractures recorded was 79. Of these 79 repeat VCFs, 21 were due trauma/fall, 14 were associated with absence of osteoporosis treatment or lack of treatment compliance, 4 did not undergo post procedure physical therapy, 13 fractures were associated with a failure to follow safe movement guidelines, 8 incident fractures occurred in patients with steroid dependent osteoporoses, 2 fractures occurred in patients with a diagnosis of multiple myeloma and no underlying cause or association was found in 17 fractures. Of these 79 repeat fractures 42 (53.2%) occurred adjacent to vertebral levels previously augmented/treated. Out of the 79 repeat fractures identified 36 (45.6%) occurred within one year of previous fracture and 53 (67.1%) occurred within 2 years.

Conclusion

Patients who have experienced an osteoporotic VCF are at high risk for experiencing a repeat fracture. Fracture risk remains high unless these patients are diligently managed following their vertebral augmentation procedure. The relatively short time frame from initial fracture to repeat fracture identified favors early identification and aggressive management of underlying risk factors.

References/Financial Disclosures

1.Rad AE, Gray LA, Kallmes DF. Incident vertebral fractures in patients not undergoing vertebroplasty. J Vasc Interv Radiol 2010;21:856-860
2. Hiwatashi A, Yoshiura T, Yamashita K, et al. Subsequent fracture after percutaneous vertebroplasty can be predicted multidetector row CT. AJNR Am J Neuroradiol 2009;30:1830-1834
3. Lee WS, Sung KH, Jeong HT, et al. Risk factors of developing new symptomatic vertebral compression fractures after percutaneous vertebroplasty in osteoporotic patients. Eur Spine J 2006;15:1777-1783
4. Trout AT, Kallmes DF, Kaufmann TJ. New fractures after vertebroplasty: adjacent fractures occur significantly sooner. AJNR Am J Neuroradiol 2006;27:217-223

Financial Disclosures: Dr. Ortiz â

General Spine

Lubdha, M, Shah, M.D.
Cameron, Evans, M.D., Non ASSR Member
Anne, Osborn, M.D., Non ASSR Member

Paper/Non-Mentor

Purpose

Poor understanding of cauda equina syndrome (CES) has lead to overzealous emergent spine imaging. This study will review the clinical definition of CES and the various causative pathologies in order to suggest an algorithm for the evaluation of such patients. Our aim is to help clarify appropriate indications for MR imaging for lumbar spine in the emergency setting.

Methods & Materials

A retrospective review of the radiology information system was completed for MRI lumbar spine studies performed over a 12-month period for the indication of â

Interventional Spine

Eren, Erdem, M.D.
Sertac, Akdol, M.D., Non ASSR Member
Adewumi, Amole, M.D., Non ASSR Member
Katy, Fryar, R.N., Non ASSR Member
Robert, W, Eberle, M.S., Non ASSR Member

Paper/Non-Mentor

Purpose

To investigate the safety and efficacy of Radiofrequency Kyphoplasty (RFK) in patients with malignant vertebral compression fractures (VCFs).

Methods & Materials

Between December, 2008 and May 2009, a consecutive series of 66 RFK procedures were performed by the author for VCF secondary to multiple myeloma. The novel technique of RFK incorporates the use of navigational osteotomes for controlled cavity creation, RF energy to enhance the PMMA into UHV-PMMA which allows for longer working times (up to 35 minutes), and the ability to perform intermittent delivery with up to 90 second pauses for trabecular interdigitation, intravertebral polymerization and vertebral height restoration. Pre- and post-operatively, a standard 10-point visual analog scale (VAS) was utilized to assess back pain. Pain medication use and activity categories were defined and monitored for changes before and after RFK. All patients were followed for six-months post-operatively.

Results

At six-months post-operatively, significant improvement in pain, activity and narcotic use was observed (p < 0.001). There were no pulmonary or neurological complications, and one patient with radiographic evidence of asymptomatic leakage of PMMA into the vertebral disc space.

Conclusion

We report optimum safety and efficacy results in the treatment of malignant VCFs with a novel RFK technique in which controlled delivery of an ultra-high viscosity PMMA is utilized for fracture stabilization. The deposition of PMMA with RFK is predictable and uniform, and can be performed without the PMMA handling constraints that may be encountered with VP and BKP. The safety and efficacy we observed and reported achieved equivalency with other methods of treatment for VCF stabilization.

References/Financial Disclosures

DFine Inc.

General Spine

Mike, Abdulhadi, MD
Paolo, Nucifora, MD, PhD, Non ASSR Member
Joseph, Perno, MD, Non ASSR Member

Paper/Non-Mentor

Purpose

Purpose: To compare cord lesion conspicuity using 3D fast spin echo (FSE) driven equilibrium T2-weighted imaging (T2WI) to conventional 2D FSE T2WI in patients with cervical spondylotic myelopathy.

Methods & Materials

Methods: IRB approved retrospective case series analysis of 31 adult patients undergoing cervical spine MRI on a 1.5 tesla Siemens Avanto system for cervical spondylosis who had both pulse sequences performed. Lesion dimensions, mean signal intensity of cord lesions and signal intensity of nearby normal cord were measured on each set of images. An unpaired studentâ

Interventional Spine

STEFANO, MARCIA, MD
STEFANO, MARINI, MD, Non ASSR Member
EMANUELE, PIRAS, MD, Non ASSR Member
MARIANGELA, MARRAS, MD, Non ASSR Member
GIORGIO, MALLARINI, PROF, Non ASSR Member

Paper/Non-Mentor

Purpose

The aim to study was to evaluate the effectiveness of a new device for balloon kyphoplasty in the treatment of traumatic vertebral fractures by means of pain reduction, height restauration, the duration of the procedure and the radiological exposure.

Methods & Materials

From June to October 2009 we performed percutaneous kyphoplasty on 18 patients (5 male, 13 female, average age: 64,4) with traumatic vertebral fractures using the new kit called â

General Spine

Sujin, Kim, DR
Joon Woo, Lee, Dr, Non ASSR Member
Heung Sik, Kang, Dr, Non ASSR Member
Mi Sook, Sung, Dr, Non ASSR Member
Guen Young, Lee, Dr, Non ASSR Member
Ji Young, Hwang, Dr, Non ASSR Member

Paper/Non-Mentor

Purpose

The purpose of this study was to evaluate the success rate and effectiveness of fluoroscopy-guided intra-articular facet joint steroid injection for the management of low back pain, as well as to document the incidence of epidural leakage, by a retrospective review of medical records and fluoroscopic arthrograms.

Methods & Materials

All patients had undergone intra-articular facet joint steroid injection in 2007 and had follow-up post-treatment medical records. The response to treatment was analyzed on the basis of chart documentation (aggravated, no change, slightly improved, much improved, no pain) in January 2010. Fluoroscopic arthrograms of intra-articular facet joint steroid injections were retrospectively analyzed by two radiologists in consensus.

Results

In total, 320 facet joint injections of 244 consecutive patients (187 women, 57men; mean age, 68.2 + 11.3 years) were included in this study. Of the 244 patients, 85.2 % (n=208) showed improvement after an initial intra-articular facet joint steroid injection. A total of 77.8 % (n=162) of the patients showed symptom recurrence, with 69 days of median symptom-free interval, while 30.3 % (n = 74) of the patients showed symptom-free intervals of more than six months. The success rate of intra-articular injection was 100% under fluoroscopic guidance. Overall, 74 cases (33.3 %) of 222 intra-articular facet joint steroid injections showed epidural leakage in fluoroscopic arthrograms.

Conclusion

Fluoroscopy-guided intra-articular facet joint injection is a reliable and easy technique for the management of low back pain, with excellent short-term and good long-term results. Epidural leakage during intra-articular facet joint injection was detected in approximately one-third of the cases.

References/Financial Disclosures

This study is supported by grant no 02-2010-034 from the SNUBH Research Fund.

Interventional Spine

STEFANO, MARCIA, MD
STEFANO, MARINI, MD, Non ASSR Member
EMANUELE, PIRAS, MD, Non ASSR Member
VALERIA, ERBI, MD, Non ASSR Member
MARIANGELA, MARRAS, MD, Non ASSR Member
GIORGIO, MALLARINI, PROF, Non ASSR Member

Paper/Non-Mentor

Purpose

The aim of this study is to prove the efficacy of totally percutaneous dynamic screws in the treatment of low back pain due to high grade disc degeneration, with involvement of facet joints and narrowing of the spinal canal, especially in L5S1.

Methods & Materials

Twenty patients(fifteen males, five females, average age: 63.1), with low back pain due to black disc L5S1 (Pfirmann grade: 4-5) with severe degeneration of zygapophysial joints and spinal stenosis at the same level were selected for implantation of percutaneous dynamic screws. Diagnosis was confirmed by conventional X-Ray, CTms and MRI. Each procedure was performed using a Percudyn system (Interventional Spine Inc., U.S.). All devices were implanted under fluoroscopic guidance and with local anaesthesia. Clinical evaluation, assessment of pain by mean of a 11-points visual analogue scale (VAS, 0-10) and of function by means of the Oswestry disability scale(ODI 0-100%) was performed at baseline and at one month after the procedure. CTms checks has been performed before and after the procedure and at one month. We also evaluated the areas of both neuroforamens and of the spinal canal before and after the implantation.

Results

A total of 20 intervertebral spaces(19 L5S1, 1 L4L5) were treated in the 20 patients enrolled in the study. Baseline pain was 8.8 ± 1.3, baseline ODI was 64.6 ± 17.3%. At one month, pain was 5.4 ± 2.2, while ODI was 47.7 ± 20.0%(p<0.01). We reported an increase of 14.8% e 16.9% in the areas of the foramens(Av. Area Dx before: 0.97, after: 1.12mm3, Av. Area Sn before: 1.03, after: 1.2mm3) and an increase of 13.0% in spinal canal dimension(Av. Axial area before: 2.09, after: 2.36). Only 35% of patients were still on analgesic drugs at one month follow up(compared with 80% before treatment). No intraprocedural side effects.

Conclusion

From our preliminary data, implant of percutaneous dynamic screws is an effective and safe procedure in reducing low back pain in patients with severe disc degeneration.

References/Financial Disclosures

Consultant of Interventional Spine Inc., U.S.