Presentation is loading. Please wait.

Presentation is loading. Please wait.

Abstract # AM29ABS00808 Long Term Patient-Centered Clinical Outcomes of Lumbar Arthrodesis in Degenerative Disc Disease: A Systematic Review with Meta.

Similar presentations


Presentation on theme: "Abstract # AM29ABS00808 Long Term Patient-Centered Clinical Outcomes of Lumbar Arthrodesis in Degenerative Disc Disease: A Systematic Review with Meta."— Presentation transcript:

1 Abstract # AM29ABS00808 Long Term Patient-Centered Clinical Outcomes of Lumbar Arthrodesis in Degenerative Disc Disease: A Systematic Review with Meta Analysis Noshchenko, Andriy; Lindley, Emily M.; Burger, Evalina L.; Cain, Christopher M.J.; Patel, Vikas V.

2 Introduction The effective treatment of lumbar spondylosis is a complex clinical and economic concern for patients and health care providers.

3 The purpose of this study
Evaluate long-term patient-centered clinical outcomes after lumbar arthrodesis, with or without decompression for lumbar spondylosis Compare these outcomes to those of alternative treatments, including arthroplasty, decompression only and nonsurgical methods

4 Methods Comprehensive literature search: MEDLINE, EMBASE, the Cochrane Library, and other sources Selection of the publications Quality of the selected studies assessment (Cochrane Back Review Group scale) Data extraction Meta analysis of the combined data Level of evidence assessment (GRADE)

5 Methods: Selection criteria
Study design: randomized controlled clinical trials (RCT) Diagnosis: lumbar degenerative disc disease with or without stenosis chronic back and/or leg pain spondylolisthesis grade I-II Patient age: >18 years old

6 Methods: Selection criteria
Treatment: 1 or 2 level lumbar arthrodesis (ALIF, PLIF, TLIF, PLF, ALIF&PLF) 1 or 2 level lumbar arthroplasty decompression without arthrodesis conservative treatment Follow-up (months): 24 >24

7 Methods: Clinical outcomes
Patient-centered clinical outcomes assessment by one or a few standardized scales such as: Oswestry Disability Index (ODI) European Quality of Life questionnaire (EQL) Roland Morris Disability Questionnaire (RMDQ) SF-36 physical scale (PCS) Visual Analog or Numeric Rating scale of back pain (VAS/NRS back pain) Visual Analog or Numeric Rating scale of leg pain (VAS/NRS leg pain) Dallas Pain Questionnaire (DPQ) Japanese Orthopedic Association Score (JOAS)

8 Methods: Measures of treatment effect

9 Results: Literature search
Of 1411 total citations, 38 RCTs of 5738 participants were included in the review [1-38] 37 RCTs were included in meta analysis

10 Results: Studies quality assessment
Majority of studies (36) had moderate quality having score ranged from 6 to 9 of 12 by Cochrane Back Review Group scale, two studies had low quality with scores: 4, and 5 Risk of following types of biases were revealed: Type of bias Percent of studies Performance 100% Detection Selection 45% Attrition 18.4%

11 Results: Pooled treatment effect
Questionnaires Follow-up, months Studies, number Patients, number Standardized difference in mean (Hedges’s g) 95% Cl P-value Heterogeneity Lumbar arthrodesis (1 or 2 levels) EQL; ODI; RMDQ; SF-36(PCS); NRS (back pain); NRS (leg pain); JOAS; DPQ 12-24 35 3574 ** 0.9; 1.2 <0.001 High (I2=90%) 36-108 11 1108 ** 0.7; 1.0 High (I2=78%) Non surgical treatment EQL; ODI; RMDQ; SF-36(PCS); NRS (back pain); NRS (leg pain); 7 535 * 0.3; 0.7 High (I2=63%) 48-72 3 299 0.2; 0.9 High (I2=75%) Lumbar decompression without arthrodesis EQL; RMDQ; SF-36(PCS); DPQ 2 427 0.7 * 0.6; 0.8 Low (I2=0%) 399 0.6 * 0.5; 0.7 Lumbar arthroplasty EQL; ODI; SF-36(PCS); NRS (back pain); NRS (leg pain) 1186 ** 1.2; 1.5 Moderate (I2=56%) 60 216 1.2; 1.6 Note: **, strong treatment effect; *, moderate treatment effect

12 Results: Comparative meta analysis
Treatment Questionnaires Follow-up, months Studies, number Patients, number Standardized difference in mean (Hedges’s g) 95% Cl P-value Heterogeneity Lumbar arthrodesis versus non surgical treatment EQL; ODI; SF-36(PCS); NRS (back pain); NRS (leg pain) 12-24 7 1395 ** 0.3; 0.9 <0.001 High (I2=90%) 48-72 3 797 * -0.1; 1.5 0.125 Moderate (I2=58%) Lumbar arthrodesis with decompression versus decompression only EQL; RMDQ; SF-36(PCS); DPQ 2 845 0.1; 0.3 0.007 Low (I2=0%) 48-60 836 0.002 Lumbar arthrodesis versus lumbar arthroplasty EQL; ODI; SF-36(PCS); NRS (back pain); NRS (leg pain) 6 1521 * -0.3;-0.1 60 399 * -0.3; 0.2 0.625 Note: **, moderate difference; *, low difference

13 Discussion/Level of evidence
Results Level of evidence (GRADE) Lumbar arthrodesis provide strong long term patient centered treatment effect in majority of patients with lumbar spondylosis suffered from chronic discogenic low back and leg pain, in particular after 3-6 months of unsuccessful conservative treatment Moderate One-two year postoperative patient centered clinical outcomes after lumbar arthrodesis significantly exceed the same outcomes after non surgical treatment, the difference is moderate One-six year postoperative patient centered clinical outcomes after decompression with lumbar arthrodesis significantly exceed the same outcomes after decompression without arthrodesis, however, the difference is low Low One-two year postoperative patient centered clinical outcomes after lumbar arthrodesis significantly inferior the same outcomes after lumbar arthroplasty, however, the difference is low

14 Conclusion Surgical stabilization of the lumbar spine is an effective treatment for lumbar spondylosis, in particular for patients with severe chronic low back pain that has been resistant to three or more months of conservative therapy

15 Thank You

16 References Boden SD, Kang J, Sandhu H, Heller JG. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. Spine (Phila Pa 1976). 2002;27(23): Vaccaro AR, Anderson DG, Patel T, Fischgrund J, Truumees E, Herkowitz HN, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine. 2005;30(24): Haid RW, Jr., Branch CL, Jr., Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J. 2004;4(5):527-38; discussion 38-9. Glassman SD, Carreon LY, Djurasovic M, Campbell MJ, Puno RM, Johnson JR, et al. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. Spine (Phila Pa 1976). 2008;33(26): Dimar JR, 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am. 2009;91(6): Dawson E, Bae HW, Burkus JK, Stambough JL, Glassman SD. Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with an osteoconductive bulking agent in posterolateral arthrodesis with instrumentation. J Bone Joint Surg Am. 2009;91(7): Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. Journal of Spinal Disorders & Techniques. 2002;15(5): Burkus JK, Sandhu HS, Gornet MF, Longley MC. Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. Journal of Bone & Joint Surgery - American Volume. 2005;87(6): Berg S, Tullberg T, Branth B, Olerud C, Tropp H. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J. 2009;18(10): PMCID: Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). 2005;30(14): Guyer RD, McAfee PC, Banco RJ, Bitan FD, Cappuccino A, Geisler FH, et al. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up. Spine J. 2009;9(5): Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO, 3rd, Haider TT, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine (Phila Pa 1976). 2007;32(11): ; discussion 63. Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ. 2005;330(7502):1233. PMCID: Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003;28(17): Brox JI, Reikeras O, Nygaard O, Sorensen R, Indahl A, Holm I, et al. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006;122(1-2): Brox JI, Nygaard Ø P, Holm I, Keller A, Ingebrigtsen T, Reikerås O. Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain. Annals of the rheumatic diseases [serial on the Internet]. 2010; (9): Available from: Fritzell P, Hagg O, Wessberg P, Nordwall A Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001;26(23): ; discussion 32-4.

17 References Sasso RC, Kitchel SH, Dawson EG. A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device. Spine (Phila Pa 1976). 2004;29(2):113-22; discussion 21-2. Gornet MF, Burkus JK, Dryer RF, Peloza JH. Lumbar disc arthroplasty with MAVERICK disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial. Spine. 2011;36(25):E Delamarter R, Zigler JE, Balderston RA, Cammisa FP, Goldstein JA, Spivak JM. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months. Journal of Bone & Joint Surgery - American Volume. 2011;93(8): Zigler JE. Five-Year Results of the ProDisc-L Multicenter, Prospective, Randomized, Controlled Trial Comparing ProDisc-L With Circumferential Spinal Fusion for Single-Level Disabling Degenerative Disk Disease. Seminars in Spine Surgery. 2012;24(1):25-31. Sasso RC, Foulk DM, Hahn M. Prospective, randomized trial of metal-on-metal artificial lumbar disc replacement: initial results for treatment of discogenic pain. Spine. 2008;33(2): McKenna PJ, Freeman BJ, Mulholland RC, Grevitt MP, Webb JK, Mehdian SH. A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results. Eur Spine J. 2005;14(8): Xue H, Tu Y, Cai M. Comparison of unilateral versus bilateral instrumented transforaminal lumbar interbody fusion in degenerative lumbar diseases. Spine Journal: Official Journal of the North American Spine Society. 2012;12(3): Oestergaard LG, Nielsen CV, Bunger CE, Sogaard R, Fruensgaard S, Helmig P, et al. The effect of early initiation of rehabilitation after lumbar spinal fusion: A randomized clinical study. Spine. 2012;37(21): Slatis P, Malmivaara A, Heliovaara M, Sainio P, Herno A, Kankare J, et al. Long-term results of surgery for lumbar spinal stenosis: a randomised controlled trial.[Erratum appears in Eur Spine J Jan;21(1):180]. European Spine Journal. 2011;20(7): PMCID: PMC Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine. 2012;37(12): Ohtori S, Koshi T, Yamashita M, Yamauchi K, Inoue G, Suzuki M, et al. Surgical versus nonsurgical treatment of selected patients with discogenic low back pain: a small-sized randomized trial. Spine. 2011;36(5): Ohtori S, Suzuki M, Koshi T, Takaso M, Yamashita M, Yamauchi K, et al. Single-level instrumented posterolateral fusion of the lumbar spine with a local bone graft versus an iliac crest bone graft: a prospective, randomized study with a 2-year follow-up. European Spine Journal. 2011;20(4): PMCID: PMC Jiya TU, Smit T, van Royen BJ, Mullender M. Posterior lumbar interbody fusion using non resorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices. Clinical outcome at a minimum of 2-year follow-up. European Spine Journal. 2011;20(4): PMCID: PMC Abbott AD, Tyni-Lenné R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine [serial on the Internet]. 2010; (8): Available from: Thalgott JS, Fogarty ME, Giuffre JM, Christenson SD, Epstein AK, Aprill C. A prospective, randomized, blinded, single-site study to evaluate the clinical and radiographic differences between frozen and freeze-dried allograft when used as part of a circumferential anterior lumbar interbody fusion procedure. Spine. 2009;34(12): Dai L-Y, Jiang L-S. Single-level instrumented posterolateral fusion of lumbar spine with beta-tricalcium phosphate versus autograft: a prospective, randomized study with 3-year follow-up. Spine. 2008;33(12): Smorgick Y, Park DK, Baker KC, Lurie JD, Tosteson TD, Zhao W, et al. Single- versus multilevel fusion for single-level degenerative spondylolisthesis and multilevel lumbar stenosis: four-year results of the spine patient outcomes research trial. Spine (Phila Pa 1976). 2013;38(10): PMCID: Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, et al. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011;36(24): PMCID: Soegaard R, Bunger CE, Christiansen T, Hoy K, Eiskjaer SP, Christensen FB. Circumferential fusion is dominant over posterolateral fusion in a long-term perspective: cost-utility evaluation of a randomized controlled trial in severe, chronic low back pain. Spine. 2007;32(22): Hallett A, Huntley JS, Gibson JN. Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion. Spine [serial on the Internet]. 2007; (13): Available from: Bjarke Christensen F, Stender Hansen E, Laursen M, Thomsen K, Bunger CE. Long-term functional outcome of pedicle screw instrumentation as a support for posterolateral spinal fusion: randomized clinical study with a 5-year follow-up. Spine (Phila Pa 1976). 2002;27(12):


Download ppt "Abstract # AM29ABS00808 Long Term Patient-Centered Clinical Outcomes of Lumbar Arthrodesis in Degenerative Disc Disease: A Systematic Review with Meta."

Similar presentations


Ads by Google