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Erschienen in: Current Reviews in Musculoskeletal Medicine 2/2017

22.03.2017 | Motion Preserving Spine Surgery (C Kepler, section editor)

Interspinous implants: are the new implants better than the last generation? A review

verfasst von: Michael Pintauro, Alexander Duffy, Payman Vahedi, George Rymarczuk, Joshua Heller

Erschienen in: Current Reviews in Musculoskeletal Medicine | Ausgabe 2/2017

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Abstract

Purpose of review

Interspinous process devices (IPDs) are used in the surgical treatment of lumbar spinal stenosis. The purpose of this review is to compare the first generation with the next-generation devices in terms of complications, device failure, reoperation rates, symptom relief, and outcome.

Recent findings

Thirty-seven studies were included from 2011 to 2016. Device failure occurred at a mean of 3.7%, with a lower tendency to happen with next-generation IPDs. Reoperations occurred at a lower rate with the next-generation devices, with a mean follow up of 24 months (3.7% vs. 11.1%). The clinical outcome is not influenced by the type of IPD.

Summary

The long-term functionality of these devices is questionable, with radiologic changes and recurrence of symptoms often seen by 2 years following implantation. Next-generation devices do not appear to be subject to the same “bounce back” effect of symptom re-emergence after several years.
Literatur
1.
Zurück zum Zitat Sapico FL, Montgomerie JZ. Pyogenic vertebral osteomyelitis: report of nine cases and review of the literature. Rev Infect Dis. 1979;1(5):754–76.CrossRefPubMed Sapico FL, Montgomerie JZ. Pyogenic vertebral osteomyelitis: report of nine cases and review of the literature. Rev Infect Dis. 1979;1(5):754–76.CrossRefPubMed
4.
Zurück zum Zitat Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the Maine lumbar spine study. Spine. 2000;25(5):556–62.CrossRefPubMed Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the Maine lumbar spine study. Spine. 2000;25(5):556–62.CrossRefPubMed
8.
Zurück zum Zitat Puzzilli F, Gazzeri R, Galarza M, Neroni M, Panagiotopoulos K, Bolognini A, et al. Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol Neurosurg. 2014;124:166–74. doi:10.1016/j.clineuro.2014.07.004.CrossRefPubMed Puzzilli F, Gazzeri R, Galarza M, Neroni M, Panagiotopoulos K, Bolognini A, et al. Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol Neurosurg. 2014;124:166–74. doi:10.​1016/​j.​clineuro.​2014.​07.​004.CrossRefPubMed
9.
Zurück zum Zitat Huang W, Chang Z, Zhang J, Song R, Yu X. Interspinous process stabilization with rocker via unilateral approach versus X-Stop via bilateral approach for lumbar spinal stenosis: a comparative study. BMC Musculoskelet Disord. 16:328. doi:10.1186/s12891-015-0786-9. Huang W, Chang Z, Zhang J, Song R, Yu X. Interspinous process stabilization with rocker via unilateral approach versus X-Stop via bilateral approach for lumbar spinal stenosis: a comparative study. BMC Musculoskelet Disord. 16:328. doi:10.​1186/​s12891-015-0786-9.
10.
11.
Zurück zum Zitat Verhoof OJ, Bron JL, Wapstra FH, et al. High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J. 2008;17(2):188–92.CrossRefPubMed Verhoof OJ, Bron JL, Wapstra FH, et al. High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J. 2008;17(2):188–92.CrossRefPubMed
12.
Zurück zum Zitat Daentzer D, Hurschler C, Seehaus F, Noll C, Schwarze M. Posterior dynamic stabilization in the lumbar spine—24 months results of a prospective clinical and radiological study with an interspinous distraction device. BMC Musculoskelet Disord. 2016;17:90. doi:10.1186/s12891-016-0945-7.CrossRefPubMedPubMedCentral Daentzer D, Hurschler C, Seehaus F, Noll C, Schwarze M. Posterior dynamic stabilization in the lumbar spine—24 months results of a prospective clinical and radiological study with an interspinous distraction device. BMC Musculoskelet Disord. 2016;17:90. doi:10.​1186/​s12891-016-0945-7.CrossRefPubMedPubMedCentral
13.
Zurück zum Zitat Marsh GDJ, Mahir S, Leyte A. A prospective randomised controlled trial to assess the efficacy of dynamic stabilisation of the lumbar spine with the Wallis ligament. Eur Spine J. 2014;23(10):2156–60. doi:10.1007/s00586-014-3487-4.CrossRefPubMed Marsh GDJ, Mahir S, Leyte A. A prospective randomised controlled trial to assess the efficacy of dynamic stabilisation of the lumbar spine with the Wallis ligament. Eur Spine J. 2014;23(10):2156–60. doi:10.​1007/​s00586-014-3487-4.CrossRefPubMed
15.
Zurück zum Zitat Buric J, Pulidori M. Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series. Eur Spine J. 2011;20(8):1304–11. doi:10.1007/s00586-011-1697-6.CrossRefPubMedPubMedCentral Buric J, Pulidori M. Long-term reduction in pain and disability after surgery with the interspinous device for intervertebral assisted motion (DIAM) spinal stabilization system in patients with low back pain: 4-year follow-up from a longitudinal prospective case series. Eur Spine J. 2011;20(8):1304–11. doi:10.​1007/​s00586-011-1697-6.CrossRefPubMedPubMedCentral
16.
Zurück zum Zitat Lu K, Liliang P-C, Wang H-K, Liang C-L, Chen J-S, Chen T-B, et al. Reduction in adjacent-segment degeneration after multilevel posterior lumbar interbody fusion with proximal DIAM implantation. J Neurosurg Spine. 2015;23(2):190–6. doi:10.3171/2014.12.SPINE14666. Lu K, Liliang P-C, Wang H-K, Liang C-L, Chen J-S, Chen T-B, et al. Reduction in adjacent-segment degeneration after multilevel posterior lumbar interbody fusion with proximal DIAM implantation. J Neurosurg Spine. 2015;23(2):190–6. doi:10.​3171/​2014.​12.​SPINE14666.
17.
18.
Zurück zum Zitat Masala S, Marcia S, Taglieri A, Chiaravalloti A, Calabria E, Raguso M, et al. Degenerative lumbar spinal stenosis treatment with aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life. Interv Neuroradiol. 2016;22(2):217–26. doi:10.1177/1591019915622163.CrossRefPubMedPubMedCentral Masala S, Marcia S, Taglieri A, Chiaravalloti A, Calabria E, Raguso M, et al. Degenerative lumbar spinal stenosis treatment with aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life. Interv Neuroradiol. 2016;22(2):217–26. doi:10.​1177/​1591019915622163​.CrossRefPubMedPubMedCentral
20.
Zurück zum Zitat • Bae HW, Lauryssen C, Maislin G, Leary S, Musacchio MJ. Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. Int J Spine Surg. 2015;9:15. doi:10.14444/2015. Four-year RCT demonstrating the viability of the Coflex interlaminar device for the treatment of lumbar spinal stenosis. PubMedPubMedCentral • Bae HW, Lauryssen C, Maislin G, Leary S, Musacchio MJ. Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. Int J Spine Surg. 2015;9:15. doi:10.​14444/​2015. Four-year RCT demonstrating the viability of the Coflex interlaminar device for the treatment of lumbar spinal stenosis. PubMedPubMedCentral
23.
Zurück zum Zitat Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Davis RP, et al. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine. 2015a;40(5):275–82. doi:10.1097/BRS.0000000000000735.CrossRefPubMed Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Davis RP, et al. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine. 2015a;40(5):275–82. doi:10.​1097/​BRS.​0000000000000735​.CrossRefPubMed
24.
Zurück zum Zitat • Patel VV, Nunley PD, Whang PG, Haley TR, Bradley WD, Davis RP, et al. Superion(®) InterSpinous spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. J Pain Res. 2015b;8:657–62. doi:10.2147/JPR.S92633. A 3-year RCT demonstrating the Superion device to provide clinical improvement in patients with lumbar spinal stenosis. PubMedPubMedCentral • Patel VV, Nunley PD, Whang PG, Haley TR, Bradley WD, Davis RP, et al. Superion(®) InterSpinous spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. J Pain Res. 2015b;8:657–62. doi:10.​2147/​JPR.​S92633. A 3-year RCT demonstrating the Superion device to provide clinical improvement in patients with lumbar spinal stenosis. PubMedPubMedCentral
26.
Zurück zum Zitat Alexandre A, Alexandre AM, De Pretto M, Coro L, Saggini R, et al. One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device, one-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device. Biomed Res Int. 2014;2014:e176936. doi:10.1155/2014/176936.CrossRef Alexandre A, Alexandre AM, De Pretto M, Coro L, Saggini R, et al. One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device, one-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device. Biomed Res Int. 2014;2014:e176936. doi:10.​1155/​2014/​176936.CrossRef
27.
Zurück zum Zitat Yingsakmongkol W, Chaichankul C, Limthongkul W. Percutaneous interspinous distraction device for the treatment of lumbar spinal canal stenosis: clinical and radiographic results at 2-year follow-up. Int J Spine Surg. 2014;8:32. doi:10.14444/1032.CrossRefPubMedCentral Yingsakmongkol W, Chaichankul C, Limthongkul W. Percutaneous interspinous distraction device for the treatment of lumbar spinal canal stenosis: clinical and radiographic results at 2-year follow-up. Int J Spine Surg. 2014;8:32. doi:10.​14444/​1032.CrossRefPubMedCentral
29.
Zurück zum Zitat • Patil CG, Sarmiento JM, Ugiliweneza B, Mukherjee D, Nuno M, Liu JC, et al. Interspinous device versus laminectomy for lumbar spinal stenosis: a comparative effectiveness study. Spine J. 2014;14(8):1484–92. doi:10.1016/j.spinee.2013.08.053. A retrospective comparative study analyzing complication rates, reoperation rates, and costs in patients receiving an IPD vs. laminectomy. CrossRefPubMed • Patil CG, Sarmiento JM, Ugiliweneza B, Mukherjee D, Nuno M, Liu JC, et al. Interspinous device versus laminectomy for lumbar spinal stenosis: a comparative effectiveness study. Spine J. 2014;14(8):1484–92. doi:10.​1016/​j.​spinee.​2013.​08.​053. A retrospective comparative study analyzing complication rates, reoperation rates, and costs in patients receiving an IPD vs. laminectomy. CrossRefPubMed
33.
36.•
Zurück zum Zitat Strömqvist BH, Berg S, Gerdhem P, Johnsson R, Möller A, Sahlstrand T, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine. 2013;38(17):1436–42. doi:10.1097/BRS.0b013e31828ba413. This study compared X-STOP with decompressive surgery and found a greater need for reoperation in patients receiving X-stop. CrossRefPubMed Strömqvist BH, Berg S, Gerdhem P, Johnsson R, Möller A, Sahlstrand T, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine. 2013;38(17):1436–42. doi:10.​1097/​BRS.​0b013e31828ba413​. This study compared X-STOP with decompressive surgery and found a greater need for reoperation in patients receiving X-stop. CrossRefPubMed
38.
Zurück zum Zitat Pan B, Zhang Z-J, Lu Y-S, Xu W-G, Fu C-D. Experience with the second-generation Wallis interspinous dynamic stabilization device implanted in degenerative lumbar disease: a case series of 50 patients. Turk Neurosurg. 2014;24(5):713–9. doi:10.5137/1019-5149.JTN.9465-13.0.PubMed Pan B, Zhang Z-J, Lu Y-S, Xu W-G, Fu C-D. Experience with the second-generation Wallis interspinous dynamic stabilization device implanted in degenerative lumbar disease: a case series of 50 patients. Turk Neurosurg. 2014;24(5):713–9. doi:10.​5137/​1019-5149.​JTN.​9465-13.​0.PubMed
40.
Zurück zum Zitat Schmier J, Halevi M, Maislin G, Ong K. Comparative cost effectiveness of Coflex & interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. Clinicoecon Outcomes Res. 2014;6:125–31. doi:10.2147/CEOR.S59194.CrossRefPubMedPubMedCentral Schmier J, Halevi M, Maislin G, Ong K. Comparative cost effectiveness of Coflex & interlaminar stabilization versus instrumented posterolateral lumbar fusion for the treatment of lumbar spinal stenosis and spondylolisthesis. Clinicoecon Outcomes Res. 2014;6:125–31. doi:10.​2147/​CEOR.​S59194.CrossRefPubMedPubMedCentral
41.
Zurück zum Zitat Gazzeri R, Galarza M, Neroni M, Fiore C, Faiola A, Puzzilli F, et al. Failure rates and complications of interspinous process decompression devices: a European multicenter study. Neurosurg Focus. 2015;39(4):E14. doi:10.3171/2015.7.FOCUS15244.CrossRefPubMed Gazzeri R, Galarza M, Neroni M, Fiore C, Faiola A, Puzzilli F, et al. Failure rates and complications of interspinous process decompression devices: a European multicenter study. Neurosurg Focus. 2015;39(4):E14. doi:10.​3171/​2015.​7.​FOCUS15244.CrossRefPubMed
42.
Zurück zum Zitat Liu X, Liu Y, Lian X, Xu J. Magnetic resonance imaging on disc degeneration changes after implantation of an interspinous spacer and fusion of the adjacent segment. Int J Clin Exp Med. 2015;8(4):6097–102.PubMedPubMedCentral Liu X, Liu Y, Lian X, Xu J. Magnetic resonance imaging on disc degeneration changes after implantation of an interspinous spacer and fusion of the adjacent segment. Int J Clin Exp Med. 2015;8(4):6097–102.PubMedPubMedCentral
43.
Zurück zum Zitat Huddleston P. X-stop resulted in a higher reoperation rate than minimally invasive decompression, but both decreased symptoms of neurogenic intermittent claudication in patients with lumbar spinal stenosis. J Bone Joint Surg Am. 2015;97(22):1889. doi:10.2106/JBJS.9722.ebo101.CrossRefPubMed Huddleston P. X-stop resulted in a higher reoperation rate than minimally invasive decompression, but both decreased symptoms of neurogenic intermittent claudication in patients with lumbar spinal stenosis. J Bone Joint Surg Am. 2015;97(22):1889. doi:10.​2106/​JBJS.​9722.​ebo101.CrossRefPubMed
44.
Zurück zum Zitat • Lønne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Rønning R, et al. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine. 2015b;40(8):514–20. doi:10.1097/BRS.0000000000000798. This randomized clinical trial was terminated early because of high complication rate in the X-STOP group (33%). CrossRefPubMed • Lønne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Rønning R, et al. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine. 2015b;40(8):514–20. doi:10.​1097/​BRS.​0000000000000798​. This randomized clinical trial was terminated early because of high complication rate in the X-STOP group (33%). CrossRefPubMed
46.
Zurück zum Zitat Yue Z-J, Liu R-Y, Lu Y, Dong L-L, Li Y-Q, Lu EB. Middle-period curative effect of posterior lumbar intervertebral fusion (PLIF) and interspinous dynamic fixation (Wallis) for treatment of L45 degenerative disease and its influence on adjacent segment degeneration. Eur Rev Med Pharmacol Sci. 2015;19(23):4481–7.PubMed Yue Z-J, Liu R-Y, Lu Y, Dong L-L, Li Y-Q, Lu EB. Middle-period curative effect of posterior lumbar intervertebral fusion (PLIF) and interspinous dynamic fixation (Wallis) for treatment of L45 degenerative disease and its influence on adjacent segment degeneration. Eur Rev Med Pharmacol Sci. 2015;19(23):4481–7.PubMed
47.
Zurück zum Zitat Van den Akker-van Marle ME, Moojen WA, Arts MP, Vleggeert-Lankamp CLAM, Peul WC. Interspinous process devices versus standard conventional surgical decompression for lumbar spinal stenosis: cost-utility analysis. Spine J. 2016;16(6):702–10. doi:10.1016/j.spinee.2014.10.017.CrossRefPubMed Van den Akker-van Marle ME, Moojen WA, Arts MP, Vleggeert-Lankamp CLAM, Peul WC. Interspinous process devices versus standard conventional surgical decompression for lumbar spinal stenosis: cost-utility analysis. Spine J. 2016;16(6):702–10. doi:10.​1016/​j.​spinee.​2014.​10.​017.CrossRefPubMed
Metadaten
Titel
Interspinous implants: are the new implants better than the last generation? A review
verfasst von
Michael Pintauro
Alexander Duffy
Payman Vahedi
George Rymarczuk
Joshua Heller
Publikationsdatum
22.03.2017
Verlag
Springer US
Erschienen in
Current Reviews in Musculoskeletal Medicine / Ausgabe 2/2017
Elektronische ISSN: 1935-9748
DOI
https://doi.org/10.1007/s12178-017-9401-z

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