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Published in: European Spine Journal 10/2015

01-10-2015 | Original Article

Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study

Authors: C Röder, B. Baumgärtner, U. Berlemann, E. Aghayev

Published in: European Spine Journal | Issue 10/2015

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Abstract

Introduction

Surgical decompression for lumbar spinal stenosis (LSS) has been associated with poorer outcomes in patients with pronounced low back pain (LBP) as compared to patients with predominant leg pain. This cross registry study assessed potential benefits of the interlaminar coflex® device as an add-on to bony decompression alone.

Methods

Patients with lumbar decompression plus coflex® (SWISSspine registry) were compared with decompressed controls (Spine Tango registry). Inclusion criteria were LSS and a preoperative back pain level of ≥5 points. 1:1 propensity score-based matching was performed. Outcome measures were back and leg pain relief, COMI score improvement, patient satisfaction, complication, and revision rates.

Results

50 matched pairs without residual significant differences but age were created. At the 7–9 months follow-up interval the coflex® group had higher back (p = 0.014) and leg pain relief (p < 0.001) and COMI score improvement (p = 0.029) than the decompression group. Patient satisfaction was 90 % in both groups. No revision was documented in the coflex® and one in the decompression group (2.0 %).

Discussion

In the short-term, lumbar decompression with coflex® compared with decompression alone in patients with LSS and pronounced LBP at baseline is a safe and effective treatment option that appears beneficial regarding clinical and functional outcomes. However, residual confounding of non-measured covariables may have partially influenced our findings. Also, despite careful inclusion and exclusion of cases the cross registry approach introduces a potential for selection bias that we could not totally control for and that makes additional studies necessary.
Literature
2.
go back to reference Ammendolia C, Stuber K, de Bruin LK, Furlan AD, Kennedy CA, Rampersaud YR, Steenstra IA, Pennick V (2012) Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine 37(10):E609–616. doi:10.1097/BRS.0b013e318240d57d CrossRefPubMed Ammendolia C, Stuber K, de Bruin LK, Furlan AD, Kennedy CA, Rampersaud YR, Steenstra IA, Pennick V (2012) Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine 37(10):E609–616. doi:10.​1097/​BRS.​0b013e318240d57d​ CrossRefPubMed
4.
go back to reference Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H (2010) Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine 35(14):1329–1338. doi:10.1097/BRS.0b013e3181e0f04d PubMedCentralPubMed Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H (2010) Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine 35(14):1329–1338. doi:10.​1097/​BRS.​0b013e3181e0f04d​ PubMedCentralPubMed
5.
go back to reference 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 25(11):1424–1435 (discussion 1435–1426) CrossRefPubMed 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 25(11):1424–1435 (discussion 1435–1426) CrossRefPubMed
6.
go back to reference Munting E, Roder C, Sobottke R, Dietrich D, Aghayev E, Spine Tango Contributors (2014) Patient outcomes after laminotomy, hemilaminectomy, laminectomy and laminectomy with instrumented fusion for spinal canal stenosis: a propensity score-based study from the Spine Tango registry. Eur Spine J. doi:10.1007/s00586-014-3349-0 PubMed Munting E, Roder C, Sobottke R, Dietrich D, Aghayev E, Spine Tango Contributors (2014) Patient outcomes after laminotomy, hemilaminectomy, laminectomy and laminectomy with instrumented fusion for spinal canal stenosis: a propensity score-based study from the Spine Tango registry. Eur Spine J. doi:10.​1007/​s00586-014-3349-0 PubMed
7.
go back to reference Pearson A, Blood E, Lurie J, Abdu W, Sengupta D, Frymoyer JW, Weinstein J (2011) Predominant leg pain is associated with better surgical outcomes in degenerative spondylolisthesis and spinal stenosis: results from the Spine Patient Outcomes Research Trial (SPORT). Spine 36(3):219–229. doi:10.1097/BRS.0b013e3181d77c21 PubMedCentralCrossRefPubMed Pearson A, Blood E, Lurie J, Abdu W, Sengupta D, Frymoyer JW, Weinstein J (2011) Predominant leg pain is associated with better surgical outcomes in degenerative spondylolisthesis and spinal stenosis: results from the Spine Patient Outcomes Research Trial (SPORT). Spine 36(3):219–229. doi:10.​1097/​BRS.​0b013e3181d77c21​ PubMedCentralCrossRefPubMed
9.
go back to reference Kaech DL, Fernandez C, Lombardi-Weber D (2002) The Interspinous ‘U’: a new restabilization device for the lumbar spine. In: Kaech DL, Jinkins JR (eds) Spinal restabilization procedures. Elsevier, Amsterdam, pp 355–362 Kaech DL, Fernandez C, Lombardi-Weber D (2002) The Interspinous ‘U’: a new restabilization device for the lumbar spine. In: Kaech DL, Jinkins JR (eds) Spinal restabilization procedures. Elsevier, Amsterdam, pp 355–362
11.
go back to reference Tsai KJ, Murakami H, Lowery GL, Hutton WC (2006) A biomechanical evaluation of an interspinous device (Coflex) used to stabilize the lumbar spine. J Surg Orthop Adv 15(3):167–172PubMed Tsai KJ, Murakami H, Lowery GL, Hutton WC (2006) A biomechanical evaluation of an interspinous device (Coflex) used to stabilize the lumbar spine. J Surg Orthop Adv 15(3):167–172PubMed
14.
go back to reference Davis RJ, Errico TJ, Bae H, Auerbach JD (2013) Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. Spine 38(18):1529–1539. doi:10.1097/BRS.0b013e31829a6d0a CrossRefPubMed Davis RJ, Errico TJ, Bae H, Auerbach JD (2013) Decompression and Coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. Spine 38(18):1529–1539. doi:10.​1097/​BRS.​0b013e31829a6d0a​ CrossRefPubMed
15.
go back to reference Mannion AF, Elfering A, Staerkle R, Junge A, Grob D, Semmer NK, Jacobshagen N, Dvorak J, Boos N (2005) Outcome assessment in low back pain: how low can you go? Eur Spine J Off Pub Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 14(10):1014–1026. doi:10.1007/s00586-005-0911-9 CrossRef Mannion AF, Elfering A, Staerkle R, Junge A, Grob D, Semmer NK, Jacobshagen N, Dvorak J, Boos N (2005) Outcome assessment in low back pain: how low can you go? Eur Spine J Off Pub Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 14(10):1014–1026. doi:10.​1007/​s00586-005-0911-9 CrossRef
16.
go back to reference Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC (2008) Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine 33(1):90–94. doi:10.1097/BRS.0b013e31815e3a10 CrossRefPubMed Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC (2008) Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine 33(1):90–94. doi:10.​1097/​BRS.​0b013e31815e3a10​ CrossRefPubMed
17.
go back to reference Rosenbaum PR, Rubin DB (1983) The central role of the propensity score in observational studies for casual effects. Biometrika 70:41–55CrossRef Rosenbaum PR, Rubin DB (1983) The central role of the propensity score in observational studies for casual effects. Biometrika 70:41–55CrossRef
19.
go back to reference Kong DS, Kim ES, Eoh W (2007) One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci 22(2):330–335PubMedCentralCrossRefPubMed Kong DS, Kim ES, Eoh W (2007) One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci 22(2):330–335PubMedCentralCrossRefPubMed
22.
go back to reference Richter A, Halm HF, Hauck M, Quante M (2012) 2-Year follow-up After decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis: a prospective controlled study. J Spinal Disord Tech. doi:10.1097/BSD.0b013e31825f7203 Richter A, Halm HF, Hauck M, Quante M (2012) 2-Year follow-up After decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis: a prospective controlled study. J Spinal Disord Tech. doi:10.​1097/​BSD.​0b013e31825f7203​
25.
go back to reference Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, Vleggeert-Lankamp CL, Peul WC, Leiden-The Hague Spine Intervention Prognostic Study Group (2013) Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ 347:f6415. doi:10.1136/bmj.f6415 PubMedCentralCrossRefPubMed Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, Vleggeert-Lankamp CL, Peul WC, Leiden-The Hague Spine Intervention Prognostic Study Group (2013) Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ 347:f6415. doi:10.​1136/​bmj.​f6415 PubMedCentralCrossRefPubMed
26.
go back to reference Schmier JK, Halevi M, Maislin G, Ong K (2014) Comparative cost effectiveness of Coflex(R) interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. Clinicoecon Outcomes Res CEOR 6:125–131. doi:10.2147/CEOR.S59194 CrossRef Schmier JK, Halevi M, Maislin G, Ong K (2014) Comparative cost effectiveness of Coflex(R) interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. Clinicoecon Outcomes Res CEOR 6:125–131. doi:10.​2147/​CEOR.​S59194 CrossRef
27.
go back to reference Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN (2011) Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine 36(24):2061–2068. doi:10.1097/BRS.0b013e318235457b PubMedCentralCrossRefPubMed Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN (2011) Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine 36(24):2061–2068. doi:10.​1097/​BRS.​0b013e318235457b​ PubMedCentralCrossRefPubMed
29.
go back to reference Stromqvist BH, Berg S, Gerdhem P, Johnsson R, Moller A, Sahlstrand T, Soliman A, Tullberg T (2013) X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine 38(17):1436–1442. doi:10.1097/BRS.0b013e31828ba413 CrossRefPubMed Stromqvist BH, Berg S, Gerdhem P, Johnsson R, Moller A, Sahlstrand T, Soliman A, Tullberg T (2013) X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine 38(17):1436–1442. doi:10.​1097/​BRS.​0b013e31828ba413​ CrossRefPubMed
30.
go back to reference Beyer F, Yagdiran A, Neu P, Kaulhausen T, Eysel P, Sobottke R (2013) Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life. Eur Spine J Off Pub Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 22(9):2015–2021. doi:10.1007/s00586-013-2790-9 CrossRef Beyer F, Yagdiran A, Neu P, Kaulhausen T, Eysel P, Sobottke R (2013) Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life. Eur Spine J Off Pub Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc 22(9):2015–2021. doi:10.​1007/​s00586-013-2790-9 CrossRef
31.
go back to reference Kim KA, McDonald M, Pik JH, Khoueir P, Wang MY (2007) Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation. Neurosurg Focus 22(1):E7PubMed Kim KA, McDonald M, Pik JH, Khoueir P, Wang MY (2007) Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation. Neurosurg Focus 22(1):E7PubMed
32.
go back to reference Zang L, Du P, Hai Y, Su QJ, Lu SB, Liu T (2013) Device related complications of the Coflex interspinous process implant for the lumbar spine. Chin Med J (Engl) 126(13):2517–2522 Zang L, Du P, Hai Y, Su QJ, Lu SB, Liu T (2013) Device related complications of the Coflex interspinous process implant for the lumbar spine. Chin Med J (Engl) 126(13):2517–2522
Metadata
Title
Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study
Authors
C Röder
B. Baumgärtner
U. Berlemann
E. Aghayev
Publication date
01-10-2015
Publisher
Springer Berlin Heidelberg
Published in
European Spine Journal / Issue 10/2015
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI
https://doi.org/10.1007/s00586-015-4124-6

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