{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T03:00:29Z","timestamp":1791255629449,"version":"4.1.0"},"reference-count":27,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:sec><jats:title>OBJECTIVE<\/jats:title><jats:p>Despite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics\u2019 Maverick total disc replacement.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Patients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement \u2265 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Compared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4\/382) at 1 year, 2.6% (9\/345) at 2 years, and 5.9% (11\/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Lumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.<\/jats:p><jats:p>Clinical trial registration no.: NCT00635843 (clinicaltrials.gov)<\/jats:p><\/jats:sec>","DOI":"10.3171\/2019.2.spine181037","type":"journal-article","created":{"date-parts":[[2019,5,17]],"date-time":"2019-05-17T22:29:01Z","timestamp":1558132141000},"page":"347-356","source":"Crossref","is-referenced-by-count":27,"title":["Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study"],"prefix":"10.3171","volume":"31","author":[{"given":"Matthew F.","family":"Gornet","sequence":"first","affiliation":[{"name":"The Orthopedic Center of St. Louis, St. Louis, Missouri;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Kenneth","family":"Burkus","sequence":"additional","affiliation":[{"name":"Wilderness Spine Services, Columbus, Georgia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Randall F.","family":"Dryer","sequence":"additional","affiliation":[{"name":"Central Texas Spine Institute, Austin, Texas;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John H.","family":"Peloza","sequence":"additional","affiliation":[{"name":"Center for Spine Care, Dallas, Texas; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francine W.","family":"Schranck","sequence":"additional","affiliation":[{"name":"SPIRITT Research, St. Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne G.","family":"Copay","sequence":"additional","affiliation":[{"name":"SPIRITT Research, St. Louis, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1","series-title":"Int J Spine Surg","doi-asserted-by":"publisher","first-page":"201","DOI":"10.14444\/5029","article-title":"We need to talk about lumbar total disc replacement","volume":"12","author":"Beatty S","year":"2018","unstructured":"Beatty S: We need to talk about lumbar total disc replacement. Int J Spine Surg 12:201\u2013240, 201810.14444\/502930276080"},{"key":"b2","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"1512","DOI":"10.1007\/s00586-009-1047-0","article-title":"Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up","volume":"18","author":"Berg S","year":"2009","unstructured":"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 18:1512\u20131519, 200910.1007\/s00586-009-1047-019506919"},{"issue":"30","key":"b3","series-title":"Spine (Phila Pa 1976)","first-page":"1565","article-title":"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","author":"Blumenthal S","unstructured":"Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, : 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) 30:1565\u20131575, E387\u2013E391, 2005"},{"key":"b4","series-title":"J Bone Joint Surg Am","first-page":"705","article-title":"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","volume":"93","author":"Delamarter R","year":"2011","unstructured":"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. J Bone Joint Surg Am 93:705\u2013715, 201121398574"},{"issue":"25","key":"b5","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2940","DOI":"10.1097\/00007632-200011150-00017","article-title":"The Oswestry Disability Index","author":"Fairbank JCT","year":"2000","unstructured":"Fairbank JCT, Pynsent PB: The Oswestry Disability Index. Spine (Phila Pa 1976) 25:2940\u20132952, 200010.1097\/00007632-200011150-00017"},{"key":"b6","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1016\/j.spinee.2004.09.006","article-title":"Lumbar disc arthroplasty","volume":"5","author":"Gamradt SC","year":"2005","unstructured":"Gamradt SC, Wang JC: Lumbar disc arthroplasty. Spine J 5:95\u2013103, 200510.1016\/j.spinee.2004.09.00615653090"},{"issue":"40","key":"b7","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1873","DOI":"10.1097\/BRS.0000000000001245","article-title":"Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activL multicenter randomized controlled IDE clinical trial","author":"Garcia R Jr","year":"2015","unstructured":"Garcia R Jr, Yue JJ, Blumenthal S, Coric D, Patel VV, Leary SP, : Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activL multicenter randomized controlled IDE clinical trial. Spine (Phila Pa 1976) 40:1873\u20131881, 201510.1097\/BRS.0000000000001245"},{"issue":"36","key":"b8","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"E1600","DOI":"10.1097\/BRS.0b013e318217668f","article-title":"Lumbar disc arthroplasty with Maverick disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial","author":"Gornet MF","year":"2011","unstructured":"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 (Phila Pa 1976) 36:E1600\u2013E1611, 201110.1097\/BRS.0b013e318217668f"},{"issue":"38","key":"b9","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1970","DOI":"10.1097\/BRS.0b013e3182a62527","article-title":"Perioperative complications and mortality after spinal fusions: analysis of trends and risk factors","author":"Goz V","year":"2013","unstructured":"Goz V, Weinreb JH, McCarthy I, Schwab F, Lafage V, Errico TJ: Perioperative complications and mortality after spinal fusions: analysis of trends and risk factors. Spine (Phila Pa 1976) 38:1970\u20131976, 201310.1097\/BRS.0b013e3182a62527"},{"key":"b10","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"374","DOI":"10.1016\/j.spinee.2008.08.007","article-title":"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","volume":"9","author":"Guyer RD","year":"2009","unstructured":"Guyer RD, McAfee PC, Banco RJ, Bitan FD, Cappuccino A, Geisler FH, : 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 9:374\u2013386, 20091880506610.1016\/j.spinee.2008.08.007"},{"issue":"39","key":"b11","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1097\/BRS.0000000000000319","article-title":"Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up","author":"Guyer RD","year":"2014","unstructured":"Guyer RD, Pettine K, Roh JS, Dimmig TA, Coric D, McAfee PC, : Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up. Spine (Phila Pa 1976) 39:925\u2013931, 201410.1097\/BRS.0000000000000319"},{"issue":"41","key":"b12","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1097\/BRS.0000000000001168","article-title":"Five-year follow-up of a prospective, randomized trial comparing two lumbar total disc replacements","author":"Guyer RD","year":"2016","unstructured":"Guyer RD, Pettine K, Roh JS, Dimmig TA, Coric D, McAfee PC, : Five-year follow-up of a prospective, randomized trial comparing two lumbar total disc replacements. Spine (Phila Pa 1976) 41:3\u20138, 201610.1097\/BRS.0000000000001168"},{"issue":"32\u201338","key":"b13","series-title":"Eur Spine J","doi-asserted-by":"publisher","DOI":"10.1007\/BF02428314","article-title":"Anterior lumbar fusion using a hybrid interbody graft. A preliminary radiographic report","volume":"3","author":"Holte DC","year":"1994","unstructured":"Holte DC, O\u2019Brien JP, Renton P: Anterior lumbar fusion using a hybrid interbody graft. A preliminary radiographic report. Eur Spine J 3:32\u201338, 199410.1007\/BF02428314"},{"issue":"32","key":"b14","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2119","DOI":"10.1097\/BRS.0b013e318145a56a","article-title":"Are lumbar spine reoperation rates falling with greater use of fusion surgery and new surgical technology?","author":"Martin BI","year":"2007","unstructured":"Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA: Are lumbar spine reoperation rates falling with greater use of fusion surgery and new surgical technology? Spine (Phila Pa 1976) 32:2119\u20132126, 200710.1097\/BRS.0b013e318145a56a"},{"issue":"32","key":"b15","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1097\/01.brs.0000254104.55716.46","article-title":"Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures","author":"Martin BI","year":"2007","unstructured":"Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA: Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine (Phila Pa 1976) 32:382\u2013387, 200710.1097\/01.brs.0000254104.55716.46"},{"issue":"30","key":"b16","series-title":"Spine (Phila Pa 1976)","first-page":"1576","article-title":"A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes","author":"McAfee PC","unstructured":"McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, : A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine (Phila Pa 1976) 30:1576\u20131583, E388\u2013E390, 2005"},{"key":"b17","series-title":"J Spinal Disord Tech","doi-asserted-by":"publisher","first-page":"384","DOI":"10.1097\/00024720-200308000-00010","article-title":"Classification of heterotopic ossification (HO) in artificial disk replacement","volume":"16","author":"McAfee PC","year":"2003","unstructured":"McAfee PC, Cunningham BW, Devine J, Williams E, Yu-Yahiro J: Classification of heterotopic ossification (HO) in artificial disk replacement. J Spinal Disord Tech 16:384\u2013389, 20031290295410.1097\/00024720-200308000-00010"},{"issue":"31","key":"b18","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1217","DOI":"10.1097\/01.brs.0000217689.08487.a8","article-title":"Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc","author":"McAfee PC","year":"2006","unstructured":"McAfee PC, Geisler FH, Saiedy SS, Moore SV, Regan JJ, Guyer RD, : Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc. Spine (Phila Pa 1976) 31:1217\u20131226, 200610.1097\/01.brs.0000217689.08487.a8"},{"key":"b19","article-title":"Measuring Health. A Guide to Rating Scales and Questionnaires","author":"McDowell I","year":"1996","unstructured":"McDowell I, Newell C: Measuring Health. A Guide to Rating Scales and Questionnaires. New York: Oxford University Press, 1996"},{"key":"b20","series-title":"J Bone Joint Surg Br","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1302\/0301-620X.94B3.27825","article-title":"National in-hospital morbidity and mortality trends after lumbar fusion surgery between 1998 and 2008","volume":"94","author":"Pumberger M","year":"2012","unstructured":"Pumberger M, Chiu YL, Ma Y, Girardi FP, Mazumdar M, Memtsoudis SG: National in-hospital morbidity and mortality trends after lumbar fusion surgery between 1998 and 2008. J Bone Joint Surg Br 94:359\u2013364, 20122237154410.1302\/0301-620X.94B3.27825"},{"key":"b21","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"1417","DOI":"10.1016\/j.spinee.2013.08.028","article-title":"Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up","volume":"14","author":"Siepe CJ","year":"2014","unstructured":"Siepe CJ, Heider F, Wiechert K, Hitzl W, Ishak B, Mayer MH: Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5- to 10-year follow-up. Spine J 14:1417\u20131431, 201410.1016\/j.spinee.2013.08.02824448028"},{"key":"b22","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"2288","DOI":"10.1007\/s00586-013-2926-y","article-title":"Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial","volume":"22","author":"Sk\u00f6ld C","year":"2013","unstructured":"Sk\u00f6ld C, Tropp H, Berg S: Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J 22:2288\u20132295, 201310.1007\/s00586-013-2926-y23893083"},{"key":"b23","article-title":"SF-36 Physical and Mental Health Summary Scales: A User\u2019s Manual","author":"Ware JE","year":"1994","unstructured":"Ware JE, Kosinski M, Keller SK: SF-36 Physical and Mental Health Summary Scales: A User\u2019s Manual. Boston: The Health Institute, 1994"},{"key":"b24","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"265","DOI":"10.1016\/j.spinee.2014.09.026","article-title":"National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009","volume":"15","author":"Yoshihara H","year":"2015","unstructured":"Yoshihara H, Yoneoka D: National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Spine J 15:265\u2013271, 20152528192010.1016\/j.spinee.2014.09.026"},{"issue":"32","key":"b25","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1155","DOI":"10.1097\/BRS.0b013e318054e377","article-title":"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","author":"Zigler J","year":"2007","unstructured":"Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO III, Haider TT, : 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) 32:1155\u20131163, 200710.1097\/BRS.0b013e318054e377"},{"key":"b26","series-title":"Global Spine J","doi-asserted-by":"publisher","first-page":"413","DOI":"10.1177\/2192568217737317","article-title":"Comparison of lumbar total disc replacement with surgical spinal fusion for the treatment of single-level degenerative disc disease: a meta-analysis of 5-year outcomes from randomized controlled trials","volume":"8","author":"Zigler J","year":"2018","unstructured":"Zigler J, Gornet MF, Ferko N, Cameron C, Schranck FW, Patel L: Comparison of lumbar total disc replacement with surgical spinal fusion for the treatment of single-level degenerative disc disease: a meta-analysis of 5-year outcomes from randomized controlled trials. Global Spine J 8:413\u2013423, 201810.1177\/219256821773731729977727"},{"key":"b27","series-title":"J Neurosurg Spine","first-page":"493","article-title":"Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease","volume":"17","author":"Zigler JE","year":"2012","unstructured":"Zigler JE, Delamarter RB: Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine 17:493\u2013501, 201223082846"}],"container-title":["Journal of Neurosurgery: Spine"],"original-title":[],"link":[{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/31\/3\/article-p347.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/31\/3\/article-p347.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/31\/3\/article-p347.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,15]],"date-time":"2023-04-15T22:40:51Z","timestamp":1681598451000},"score":1,"resource":{"primary":{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/31\/3\/article-p347.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,9]]},"references-count":27,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.3171\/2019.2.spine181037","relation":{},"ISSN":["1547-5654"],"issn-type":[{"value":"1547-5654","type":"print"}],"subject":[],"published":{"date-parts":[[2019,9]]}}}