Comparison of artificial total disc replacement versus fusion for lumbar degenerative disc disease: a meta-analysis of randomized controlled trials

International Orthopaedics - Tập 37 - Trang 1315-1325 - 2013
Jiangbo Wei1, Yueming Song1, Lin Sun1, Chaoliang Lv1
1Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People’s Republic of China;

Tóm tắt

To compare the efficacy and safety of TDR to that of the fusion for the treatment of lumbar degenerative disc disease (LDDD). Randomized controlled trials comparing TDR with any other intervention for LDDD were acquired by a comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and the FDA trials register. Methodologic quality was assessed and relevant data were retrieved, and appropriate meta-analysis was performed. Two review authors independently selected studies, extracted data, and assessed risk of bias. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences. Six relevant randomized controlled trials (RCTs) involving 1,603 patients were identified and reported two year follow-up results. Patients in TDR group compared with lumbar fusion group demonstrated significant improvements in ODI, VAS scores and complication rates at the two year follow-up. Meanwhile, except for operating time in anterior group, intra-operative blood loss, operating time in posterior group, and reoperation rate were without clinical significance between the two groups. In addition, the range of motion (ROM) was maintained within normal ranges after TDR. The results showed the TDR has significant safety and efficacy comparable to lumbar fusion at two year follow-up. Although superiority compared to fusion could not be proved, by comparing clinical symptoms relieved, motion preserved, and the low reoperation rate during long-term follow-up on TDR, TDR was considered safe and effective. Therefore, the authors suggest adopting TDR on a large scale; with failure of TDR, interbody fusion would be performed.

Tài liệu tham khảo

An H, Boden SD, Kang J et al (2003) Summary statement: emerging techniques for treatment of degenerative lumbar disc disease. Spine 28:S24–S25

Booth DC, Bridwell KH, Eisenberg BA et al (1999) Minimum 5-year results of degenerative spondylolisthesis treated with decompression and instrumented posterior fusion. Spine 24:1721–1727

Glaser J, Stanley M, Sayre H et al (2003) A 10-year follow-up evaluation of lumbar spine fusion with pedicle screw fixation. Spine 28(13):1390–1395

Chou WY, Hsu CJ, Chang WN, Wong CY et al (2002) Adjacent segment degeneration after lumbar spinal posterolateral fusion with instrumentation in elderly patients. Arch Orthop Trauma Surg 122:39–43

Okuda S, Iwasaki M, Miyauchi A et al (2004) Risk factors for adjacent segment degeneration after PLIF. Spine 29:1535–1540

Brantigan JW, Neidre A, Toohey JS (2004) The Lumbar I/F Cage for posterior lumbar interbody fusion with the variable screw placement system: 10-year results of a Food and Drug Administration clinical trial. Spine J 4:681–688

Resnick DK, Choudhri TF, Dailey AT et al (2005) Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 5: Correlation between radiographic and functional outcome. J Neurosurg Spine 2:658–661

Sengupta DK, Mulholland RC (2005) Fulcrum assisted soft stabilization system: A new concept in the surgical treatment of degenerative low back pain. Spine 30:1019–1029

Lemaire JP, Carrier H, Sariali el-H et al (2005) Clinical and radiological outcomes with the Charite’ artificial disc: a 10-year minimum follow-up. J Spinal Disord Tech. 18:353–359

Siepe CJ, Mayer HM, Wiechert K et al (2006) Clinical results of total lumbar disc replacement with ProDisc II: Three-year results for different indications. Spine 31:1923–1932

Szpalski M, Gunzburg R, Mayer M (2002) Spine arthroplasty: A historical review. Eur Spine J 11:S65–S84

Ingalhalikar AV, Reddy CG et al (2009) Effect of lumbar total disc arthroplasty on the segmental motion and intradiscal pressure at the adjacent level: An in vitro biomechanical study: presented at the 2008 joint spine section meeting laboratory investigation. J Neurosurg Spine 11(6):715–723

Weisskopf M, Ohnsorge JA, Martini F et al (2008) Influence of inlay height on motion characteristics of Iumbar segments in TDR. Orthop Unfall 146(4):452–457

Guyer RD, McAfee PC, Hochschuler SH et al (2004) Prospective randomized study of the Charite artificial disc: Data from two TDR centers. Spine J 4:S252–S259

McAfee PC, Fedder IL, Saiedy S et al (2003) SB Charite’ disc replacement: Report of 60 prospective randomized cases in a US center. J Spinal Disord Tech 16:424–433

Zigler JE, Burd TA, Vialle EN et al (2003) Lumbar spine arthroplasty: Early results using the ProDisc II: Aprospective randomized trial of arthroplasty versus fusion. J Spinal Disord Tech 16:352–361

Shea B, Dube C, Moher D (2006) Assessing the quality of reports os systematic reviews: The Quorum statement compared to other tools. In: Egger M, Smith GD, Altman DG (eds) Systematic reviews in health care: meta-analysis in context. BMJ Publishing Group, London, pp 122–139

Higgins JPT, S (2011) Green “Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011].Available from www.cochrane-handbook.org

Furlan AD, Pennick V, Bombardier C et al (2009) 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 34:1929–1941

Berg S, Tullberg T, Branth B et al (2009) TDR compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J 18:1512–1519

Blumenthal S, McAfee PC, Guyer RD et al (2005) A prospective, randomized, multicenter Food and Drug Administration TDR device exemptions study of lumbar TDR with the CHARITE artificial disc versus lumbar fusion: Part I: Evaluation of clinical outcomes. Spine 30:1565–1575

Delamarter RB, Bae HW, Pradhan BB (2005) Clinical results of ProDisc-II lumbar TDR: report from the United States clinical trial. Orthop Clin North Am 36:301–313

Zigler J, Delamarter R, Spivak JM et al (2007) Results of the prospective, randomized, multicenter Food and Drug Administration TDR device exemption study of the ProDisc-L TDR versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 32:1155–1162

Delamarter BR, Zigler JE, Balderston RA et al (2011) Prospective, randomized, multicenter Food and Drug Administration TDR device exemption study of the ProDisc-L TDR compared with circumferential fusion for the treatment of two-level lumbar degenerative disc disease. J Bone Joint Surg Am 93:705–715

Gornet MF, Burkus JK, Dryer RF et al (2011) Lumbar disc arthroplasty with MAVERICK disc versus stand-alone interbody fusion. Spine 36(25):E1600–E1611

Jacobs WCH, van der Gaag NA et al (2013) Total disc replacement for chronic discogenic low back pain: A Cochrane review. Spine 38(1):24–36

Guyer RD, McAfee PC, Banco RJ et al (2009) Prospective, randomized, multicenter Food and Drug Administration TDR device exemption study of lumbar TDR with the CHARITE artificial disc versus lumbar fusion: Five-year follow-up. Spine J 9:374–386

Park C-K, Ryu K-S, Lee K-Y et al (2012) Clinical outcome of lumbar TDR using ProDisc-L in degenerative disc disease. Spine 37(8):672–677

Katsimihas M, Bailey CS, Issa K et al (2010) Prospective clinical and radiographic results of CHARITÉ III artificial total disc arthroplasty at 2- to 7-year follow-up: A Canadian experience. Can J Surg 53(6):408–4145

Zigler JE, Glenn J, Delamarter RB (2012) Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar TDR with ProDisc-L versus circumferential fusion. J Neurosurg Spine 10:19

David T (2007) Long-term results of one-level lumbar arthroplasty: Minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine 32:661–666

Putzier M, Funk JF, Schneider SV et al (2006) Charité total disc replacement—clinical and radiographical results after an average follow-up of 17 years. Eur Spine J 15(2):183–195

Pimenta L, Díaz RC, Guerrero LG (2006) Charité lumbar artificial disc retrieval: Use of a lateral minimally invasive technique. Technical note. J Neurosurg Spine 5(6):556–561

Dickman CA, Yahiro MA, Lu HTC et al (1994) Surgical treatment alternatives for fixation of unstable fractures of the thoracic and lumbar spine. A meta-analysis. Spine 19:S2266–S2273

Haher TR, Merola A, Zpinick RI et al (1995) Meta-analysis of surgical outcome in adolescent idiopathic scoliosis. A 35-year English literature review of 11,000 patients. Spine 20:1575–1584

Schulz KF, Chalmers I, Hayes RJ et al (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of effects in controlled trails. JAMA 273(5):408–412

Thông tin
Thông tin xuất bản

International Orthopaedics

Tập 37

1315-1325

Thông tin tác giả