Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life
Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use.
Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius®) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery.
Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups.
Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.
KeywordsLumbar spinal stenosis Microsurgical decompression Percutaneous interspinous spacer Quality of life Clinical outcome
FB is supported by the German Federal Ministry of Research and Education (BMBF grant 01KN1106).
Conflict of interest
- 5.Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F (2000) Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. Spine (Phila Pa 1976) 25:1424–1435; discussion 1435–1426Google Scholar
- 7.Sobottke R, Schluter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, Eysel P, Simons P, Kuchta J (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. doi: 10.1007/s00586-009-1081-y PubMedCrossRefGoogle Scholar
- 13.Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR, 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM (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 (Phila Pa 1976) 30:1351–1358. pii: 00007632-200506150-00003Google Scholar
- 15.Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio S, Cauthen JC, Ozuna RM (2004) A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 13:22–31. doi: 10.1007/s00586-003-0581-4 PubMedCrossRefGoogle Scholar
- 17.Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H (2008) Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 358:794–810. doi: 10.1056/NEJMoa0707136 PubMedCrossRefGoogle Scholar
- 20.Moojen WA, Arts MP, Brand R, Koes BW, Peul WC (2010) The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication. BMC Musculoskelet Disord 11:100. doi: 10.1186/1471-2474-11-100
- 21.Sobottke R, Rollinghoff M, Siewe J, Schlegel U, Yagdiran A, Spangenberg M, Lesch R, Eysel P, Koy T (2010) Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand-alone spacer. Minim Invasive Neurosurg 53:179–183. doi: 10.1055/s-0030-1263108 PubMedCrossRefGoogle Scholar
- 23.Richter A, Schutz C, Hauck M, Halm H (2010) Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. Eur Spine J 19:283–289. doi: 10.1007/s00586-009-1229-9 PubMedCrossRefGoogle Scholar
- 24.Van Meirhaeghe J, Fransen P, Morelli D, Craig NJ, Godde G, Mihalyi A, Collignon F (2012) Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS((R)) in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. Eur Spine J 21:2565–2572. doi: 10.1007/s00586-012-2330-z PubMedCrossRefGoogle Scholar