Abstract
Objective
This study was designed to evaluate the feasibility of the implantation of a new interspinous device (Falena) in patients with lumbar spinal stenosis. The clinical outcomes and imaging results were assessed by orthostatic MR during an up to 6-month follow-up period.
Methods
Between October 2008 and February 2010, the Falena was implanted at a single level in 26 patients (17 men; mean age, 69 (range, 54–82) years) who were affected by degenerative lumbar spinal stenosis. All of the patients were clinically evaluated before the procedure and at 1 and 3 months. Furthermore, 20 patients have completed a 6-month follow-up. Pain was assessed before and after the intervention using the Visual Analogue Scale score and the Oswestry Disability Index questionnaire. Orthostatic MR imaging was performed before the implantation and at 3 months to assess the correlation with the clinical outcome.
Results
The mean ODI score decreased from 48.9 before the device implantation to 31.2 at 1 month (p < 0.0001). The mean VAS score decreased from 7.6 before to 3.9 (p < 0.0001) at 1 month and 3.6 at 3 months after the procedure (p = 0.0115). These values were stable at 6 months evaluation. No postimplantation major complications were recorded. MRI evaluation documented in most cases an increased size of the spinal canal area. Similarly a bilateral foraminal area improvement was found. The variation of the intervertebral space height measured on the posterior wall was not significant.
Conclusions
In our preliminary experience with the Falena in a small cohort of patients, we obtained clinical and imaging results aligned to those reported with similar interspinous devices.
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References
Hilibrand AS, Nashon R (1999) Lumbar spinal stenosis: diagnosis and treatment. J Am Acad Orthop Surg 7:239–249
De Villiers PD, Booysen EL (1976) Fibrous spinal stenosis: a report on 850 myelograms with a water-soluble contrast medium. J Bone Joint Surg Am 115:140–144
Bolender NF, Schonstrom NS, Spengler DM (1985) Role of computer tomography and myelography in the diagnosis of central spinal stenosis. J Bone Joint Surg Am 67:240–246
Spengler DM (1987) Degenerative stenosis of the lumbar spine. J Bone Joint Surg Am 69:305–308
Amundsen T, Weber H, Lilleas F, Nordal HJ, Abdelnoor M, Magnaes B (1995) Lumbar spinal stenosis: clinical and radiologic features. Spine 20(10):1178–1186
Minns RJ, Walsh WK (1997) Preliminary design and experimental studies of a novel soft implant for correcting sagittal plane instability in the lumbar spine. Spine 22:1819–1825
Kim DH, Albert TJ (2007) Interspinous process spacer. J Am Acad Orthop Surg 15:200–207
Christie SD, Song JK, Fessler RG (2005) Dynamic interspinous process technology. Spine 30:S73–S78
Bono CM, Vaccaro AR (2007) Interspinous process device in the lumbar spine. Spine 20:255–261
Dyck P (1979) The stoop-test in lumbar entrapment radiculopathy. Spine 4:89–92
Chung SS, Lee CS, Kim SH (2000) Effect of low back posture on the morphology of the spinal canal. Skeletal Radiol 29:217–223
Zucherman JF, Hsu KY, Hartjen CA et al (2004) A prospective randomized multicenter study for the treatment of lumbar spinal stenosis with the X Stop interspinous implant: 1-year results. Eur Spine J 13:22–31
Zucherman JF, Hsu KY, Hartjen CA et al (2005) A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine 30:1951–1958
Lee J, Hida K, Seti T et al (2004) An interspinous process distractor (X STOP) for lumbar spinal stenosis in elderly patients: preliminary experience in 10 consecutive cases. J Spinal Disord 17:72–82
Siddiqui M, Smith FW, Wardlaw D (2007) One-year results of X-STOP Interspinous Implant for the treatment of lumbar spinal stenosis. Spine 32:1345–1348
Kuchta J, Sobottke R, Eysel P et al (2009) Two-year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis. Eur Spine J 18:823–829
Kondrashov DG, Hannibal M, Hsu KY et al (2006) Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech 19:323–327
Sobottke R, Schlüter-Brust K, Kaulhausen T et al (2009) Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J 18:1494–1503
Siddiqui M, Nicol M, Karadimas E et al (2005) The positional magnetic resonance imaging changes in the lumbar spine following insertion of a novel interspinous process distraction device. Spine 30:2677–2682
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Masala, S., Fiori, R., Bartolucci, D.A. et al. Percutaneous Decompression of Lumbar Spinal Stenosis with a New Interspinous Device. Cardiovasc Intervent Radiol 35, 368–374 (2012). https://doi.org/10.1007/s00270-011-0167-1
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DOI: https://doi.org/10.1007/s00270-011-0167-1