RESEARCH PROGRESS OF INTERSPINOUS DISTRACTION DEVICES FOR TREATMENT OF DEGENERATIVE LUMBAR SPINAL STENOSIS_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

CHENGFei ,  ZHANGChangchun , ZHUKun , XUGang

Department of Orthopaedics, the First Affiliated Hospital of Bengbu Medical College, Bengbu Anhui, 233000, P. R. China;

Corresponding author：

ZHANGChangchun, Email: zccanhui@sina.com

Keywords：

Degenerative lumbar spinal stenosis; Interspinous distraction devices; Dynamic stabilization

DOI：

10.7507/1002-1892.20160264

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Objective To review the research status in respect of interspinous distraction devices (IDD) in the treatment of degenerative lumbar spinal stenosis (DLSS). Methods Recent original articles related to IDD in the treatment of DLSS were retrieved extensively, and the effectiveness was analyzed and summarized. Results Its short-term effectiveness was superior to that of conservative treatment, no significant difference was found when compared with decompression or fusion alone. Its complication rate was higher than that of decompression or fusion alone, although complication dose not significantly affect treatment results, it still will increase the medical care cost of patients. Conclusion IDD is appropriate for patients who have failed to nonoperative treatment measures and can not tolerate open surgery, but the long-term effectiveness and durability of IDD need further research.

Citation： CHENG Fei, ZHANG Changchun, ZHU Kun, XU Gang. RESEARCH PROGRESS OF INTERSPINOUS DISTRACTION DEVICES FOR TREATMENT OF DEGENERATIVE LUMBAR SPINAL STENOSIS. Chinese Journal of Reparative and Reconstructive Surgery, 2016, 30(10): 1301-1305. doi: 10.7507/1002-1892.20160264 Copy

1.	Hur JW,Kim SH,Lee JW,et al.Clinical analysis of postoperative outcome in elderly patients with lumbar spinal stenosis.J Korean Neurosurg Soc,2007,41(3):157-160.
2.	Försth P,Ólafsson G,Carlsson T,et al.A randomized,controlled trial of fusion surgery for lumbar spinal stenosis.N Engl J Med,2016,374(15):1413-1423.
3.	Lehmann TR,Spratt KF,Tozzi JE,et al.Long-term follow-up of lower lumbar fusion patients.Spine (Phila Pa 1976),1987,12(2):97-104.
4.	Okuda S,Oda T,Yamasaki R,et al.Repeated adjacent-segment degeneration after posterior lumbar interbody fusion.J Neurosurg Spine,2014,20(5):538-541.
5.	Lee SH,Seol A,Cho TY,et al.A systematic review of interspinous dynamic stabilization.Clin Orthop Surg,2015,7(3):323-329.
6.	Bono CM,Vaccaro AR.Interspinous process devices in the lumbar spine.J Spinal Disord Tech,2007,20(3):255-261.
7.	Sénégas J.Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments:the Wallis system.Eur Spine J,2002,11 Suppl 2:S164-169.
8.	Sénégas J.Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments:the Wallis system.Eur Spine J,2002,11 Suppl 2:S164-169.
9.	Hirsch C,Breque C,Ragot S,et al.Biomechanical study of dynamic changes in L4-L5 foramen surface area in flexion and extension after implantation of four interspinous process devices.Orthop Traumatol Surg Res,2015,101(2):215-219.
10.	Wilke HJ,Drumm J,Häussler K,et al.Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure.Eur Spine J,2008,17(8):1049-1056.
11.	Marsh GD,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):2156-2160.
12.	Daentzer D,Hurschler C,Seehaus F,et al.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.
13.	Sénégas J,Vital JM,Pointillart V,et al.Clinical evaluation of a lumbar interspinous dynamic stabilization device (the Wallis sys-tem) with a 13-year mean follow-up.Neurosurg Rev,2009,32(3):335-342.
14.	Miller JD,Miller MC,Lucas MG.Erosion of the spinous process:a potential cause of interspinous process spacer failure.J Neurosurg Spine,2010,12(2):210-213.
15.	Chung KJ,Hwang YS,Koh SH.Stress fracture of bilateral posterior facet after insertion of interspinous implant.Spine (Phila Pa 1976),2009,34(10):E380-383.
16.	Zucherman JF,Hsu KY,Hartjen CA,et al.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),2005,30(12):1351-1358.
17.	Strömqvist BH,Berg S,Gerdhem P,et al.X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication:randomized controlled trial with 2-year follow-up.Spine (Phila Pa 1976),2013,38(17):1436-1442.
18.	Lønne G,Johnsen LG,Rossvoll I,et al.Minimally invasive decompression versus x-stop in lumbar spinal stenosis:a randomized controlled multicenter study.Spine (Phila Pa 1976),2015,40(2):77-85.
19.	Lønne G,Johnsen LG,Aas E,et al.Comparing cost-effectiveness of X-stop to minimally invasive decompression in lumbar spinal stenosis:a randomized controlled trial.Spine (Phila Pa 1976),2015,40(8):514-520.
20.	Patil CG,Sarmiento JM,Ugiliweneza B, et al.Interspinous device versus laminectomy for lumbar spinal stenosis:a comparative effectiveness study.Spine J,2014,14(8):1484-1492.
21.	Burnett MG,Stein SC,Bartels RH.Cost-effectiveness of current treatment strategies for lumbar spinal stenosis:nonsurgical care,laminectomy,and X-STOP.J Neurosurg Spine,2010,13(1):39-46.
22.	Beyer F,Yagdiran A,Neu P,et al.Percutaneous interspinous spacer versus open decompression:a 2-year follow-up of clinical outcome and quality of life.Eur Spine J,2013,22(9):2015-2021.
23.	Surace MF,Fagetti A,Fozzato S,et al.Lumbar spinal stenosis treatment with Aperius perclid interspinous system.Eur Spine J,2012,21 Suppl 1:S69-74.
24.	Galarza M,Fabrizi AP,Maina R,et al.Degenerative lumbar spinal stenosis with neurogenic intermittent claudication and treatment with the Aperius PercLID System:a preliminary report.Neurosurg Focus,2010,28(6):E3.
25.	Patel VV,Nunley PD,Whang PG,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,2015,8:657-662.
26.	Bini W,Miller LE,Block JE.Minimally invasive treatment of moderate lumbar spinal stenosis with the superion^® interspinous spacer.Open Orthop J,2011,5:361-367.
27.	Shabat S,Miller LE,Block JE,et al.Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer.Clin Interv Aging,2011,6:227-233.
28.	Patel VV,Whang PG,Haley TR,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 (Phila Pa 1976),2015,40(5):275-282.
29.	Hrabálek L,Wanek T,Machač J,et al.Percutaneous interspinous dynamic stabilization (in-space) in patients with degenerative disease of the lumbosacral spine-a prospective study.Rozhl Chir,2012,91(6):311-316.
30.	Kantelhardt SR,Török E,Gempt J,et al.Safety and efficacy of a new percutaneously implantable interspinous process device.Acta Neurochir (Wien),2010,152(11):1961-1967.
31.	Richter A,Schütz C,Hauck M,et al.Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinalstenosis? One-year follow up ofprospective case control study of 60 patients.Eur Spine J,2010,19(2):283-289.
32.	Davis RJ,Errico TJ,Bae H,et al.Decompression and Coflex interlaminar stabilization compared with decompression and instrumentedspinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis:two-year results from the prospective,randomized,multicenter,Food and Drug Administration Investigational Device Exemption trail.Spine (Phila Pa 1976),2013,38(18):1529-1539.
33.	Bae HW,Davis RJ,Lauryssen C,et al.Three-year follow-up of the prospective,randomized,controlled trial of coflex interlaminar stabilization vs instrumented fusion in patients with lumbar stenosis.Neurosurgery,2016,79(2):169-181.
34.	Caserta S,La Maida GA,Misaggi B,et al.Elastic stabilization alone or combined with rigid fusion in spinal surgery:a biomechanical study and clinical experience based on 82 cases.Eur Spine J,2002,11 Suppl:S192-197.
35.	Ryu SJ,Kim IS.Interspinous implant with unilateral laminotomy for bilateral decompression of degenerative lumbar spinal stenosis in elderly patients.J Korean Neurosurg Soc,2010,47(5):338-344.
36.	Ha KY,Seo JY,Kwon SE,et al.Posterior dynamic stabilization in the treatment of degenerative lumbar stenosis:validity of its rationale.J Neurosurg Spine,2013,18(1):24-31.
37.	Park SC,Yoon SH,Hong YP,et al.Minimum 2-year follow-up result of degenerative spinal stenosis treated with interspinous u (coflex).J Korean Neurosurg Soc,2009,46(4):292-299.

1. Hur JW,Kim SH,Lee JW,et al.Clinical analysis of postoperative outcome in elderly patients with lumbar spinal stenosis.J Korean Neurosurg Soc,2007,41(3):157-160.
2. Försth P,Ólafsson G,Carlsson T,et al.A randomized,controlled trial of fusion surgery for lumbar spinal stenosis.N Engl J Med,2016,374(15):1413-1423.
3. Lehmann TR,Spratt KF,Tozzi JE,et al.Long-term follow-up of lower lumbar fusion patients.Spine (Phila Pa 1976),1987,12(2):97-104.
4. Okuda S,Oda T,Yamasaki R,et al.Repeated adjacent-segment degeneration after posterior lumbar interbody fusion.J Neurosurg Spine,2014,20(5):538-541.
5. Lee SH,Seol A,Cho TY,et al.A systematic review of interspinous dynamic stabilization.Clin Orthop Surg,2015,7(3):323-329.
6. Bono CM,Vaccaro AR.Interspinous process devices in the lumbar spine.J Spinal Disord Tech,2007,20(3):255-261.
7. Sénégas J.Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments:the Wallis system.Eur Spine J,2002,11 Suppl 2:S164-169.
8. Sénégas J.Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments:the Wallis system.Eur Spine J,2002,11 Suppl 2:S164-169.
9. Hirsch C,Breque C,Ragot S,et al.Biomechanical study of dynamic changes in L4-L5 foramen surface area in flexion and extension after implantation of four interspinous process devices.Orthop Traumatol Surg Res,2015,101(2):215-219.
10. Wilke HJ,Drumm J,Häussler K,et al.Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure.Eur Spine J,2008,17(8):1049-1056.
11. Marsh GD,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):2156-2160.
12. Daentzer D,Hurschler C,Seehaus F,et al.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.
13. Sénégas J,Vital JM,Pointillart V,et al.Clinical evaluation of a lumbar interspinous dynamic stabilization device (the Wallis sys-tem) with a 13-year mean follow-up.Neurosurg Rev,2009,32(3):335-342.
14. Miller JD,Miller MC,Lucas MG.Erosion of the spinous process:a potential cause of interspinous process spacer failure.J Neurosurg Spine,2010,12(2):210-213.
15. Chung KJ,Hwang YS,Koh SH.Stress fracture of bilateral posterior facet after insertion of interspinous implant.Spine (Phila Pa 1976),2009,34(10):E380-383.
16. Zucherman JF,Hsu KY,Hartjen CA,et al.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),2005,30(12):1351-1358.
17. Strömqvist BH,Berg S,Gerdhem P,et al.X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication:randomized controlled trial with 2-year follow-up.Spine (Phila Pa 1976),2013,38(17):1436-1442.
18. Lønne G,Johnsen LG,Rossvoll I,et al.Minimally invasive decompression versus x-stop in lumbar spinal stenosis:a randomized controlled multicenter study.Spine (Phila Pa 1976),2015,40(2):77-85.
19. Lønne G,Johnsen LG,Aas E,et al.Comparing cost-effectiveness of X-stop to minimally invasive decompression in lumbar spinal stenosis:a randomized controlled trial.Spine (Phila Pa 1976),2015,40(8):514-520.
20. Patil CG,Sarmiento JM,Ugiliweneza B, et al.Interspinous device versus laminectomy for lumbar spinal stenosis:a comparative effectiveness study.Spine J,2014,14(8):1484-1492.
21. Burnett MG,Stein SC,Bartels RH.Cost-effectiveness of current treatment strategies for lumbar spinal stenosis:nonsurgical care,laminectomy,and X-STOP.J Neurosurg Spine,2010,13(1):39-46.
22. Beyer F,Yagdiran A,Neu P,et al.Percutaneous interspinous spacer versus open decompression:a 2-year follow-up of clinical outcome and quality of life.Eur Spine J,2013,22(9):2015-2021.
23. Surace MF,Fagetti A,Fozzato S,et al.Lumbar spinal stenosis treatment with Aperius perclid interspinous system.Eur Spine J,2012,21 Suppl 1:S69-74.
24. Galarza M,Fabrizi AP,Maina R,et al.Degenerative lumbar spinal stenosis with neurogenic intermittent claudication and treatment with the Aperius PercLID System:a preliminary report.Neurosurg Focus,2010,28(6):E3.
25. Patel VV,Nunley PD,Whang PG,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,2015,8:657-662.
26. Bini W,Miller LE,Block JE.Minimally invasive treatment of moderate lumbar spinal stenosis with the superion^® interspinous spacer.Open Orthop J,2011,5:361-367.
27. Shabat S,Miller LE,Block JE,et al.Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer.Clin Interv Aging,2011,6:227-233.
28. Patel VV,Whang PG,Haley TR,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 (Phila Pa 1976),2015,40(5):275-282.
29. Hrabálek L,Wanek T,Machač J,et al.Percutaneous interspinous dynamic stabilization (in-space) in patients with degenerative disease of the lumbosacral spine-a prospective study.Rozhl Chir,2012,91(6):311-316.
30. Kantelhardt SR,Török E,Gempt J,et al.Safety and efficacy of a new percutaneously implantable interspinous process device.Acta Neurochir (Wien),2010,152(11):1961-1967.
31. Richter A,Schütz C,Hauck M,et al.Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinalstenosis? One-year follow up ofprospective case control study of 60 patients.Eur Spine J,2010,19(2):283-289.
32. Davis RJ,Errico TJ,Bae H,et al.Decompression and Coflex interlaminar stabilization compared with decompression and instrumentedspinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis:two-year results from the prospective,randomized,multicenter,Food and Drug Administration Investigational Device Exemption trail.Spine (Phila Pa 1976),2013,38(18):1529-1539.
33. Bae HW,Davis RJ,Lauryssen C,et al.Three-year follow-up of the prospective,randomized,controlled trial of coflex interlaminar stabilization vs instrumented fusion in patients with lumbar stenosis.Neurosurgery,2016,79(2):169-181.
34. Caserta S,La Maida GA,Misaggi B,et al.Elastic stabilization alone or combined with rigid fusion in spinal surgery:a biomechanical study and clinical experience based on 82 cases.Eur Spine J,2002,11 Suppl:S192-197.
35. Ryu SJ,Kim IS.Interspinous implant with unilateral laminotomy for bilateral decompression of degenerative lumbar spinal stenosis in elderly patients.J Korean Neurosurg Soc,2010,47(5):338-344.
36. Ha KY,Seo JY,Kwon SE,et al.Posterior dynamic stabilization in the treatment of degenerative lumbar stenosis:validity of its rationale.J Neurosurg Spine,2013,18(1):24-31.
37. Park SC,Yoon SH,Hong YP,et al.Minimum 2-year follow-up result of degenerative spinal stenosis treated with interspinous u (coflex).J Korean Neurosurg Soc,2009,46(4):292-299.

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RESEARCH PROGRESS OF INTERSPINOUS DISTRACTION DEVICES FOR TREATMENT OF DEGENERATIVE LUMBAR SPINAL STENOSIS

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