Charité artificial disc
The origins of lumbar disc replacement started in 1966 with Fernström 1) who implanted a stainless-steel ball within 191 lumbar and 13 cervical discs spaces of 125 patients with clinical outcomes similar to fusion. However, the ball was associated with significant complications caused by subsidence and extrusions. A couple of decades later, in the early 1980s, at Charité Hospital, Dr Karin Buettner-Janz, an orthopedic spine surgeon as well as former Olympic gymnast, and Kurt Schellnack, an engineer, published their first experience with the original Charité artificial disc for the lumbar spine, which ushered in the modern era for lumbar arthroplasty 2).
The Charité artificial disc went through revisions over 6 years, resulting in the SB Charité III, and the first clinical experience was published in 1994 using the final version of the SB Charité III (DePuy Spine Inc, Raynham, Massachusetts) 3).
The clinical trial in the United States for Food and Drug Administration (FDA) approval began in 2000, and the device was cleared for use in 2004. Since then, multiple other lumbar arthroplasty devices have been developed and have become available in the United States and Europe 4).
The second generation of artificial disc design, ProDisc-L (Centinel Spine, West Chester, Pennsylvania), was granted FDA approval in 2006, followed by a third-generation artificial disc design, activL (Aesculap Implant Systems, Center Valley, Pennsylvania) in 2015.
In addition to these devices, Acroflex (Acromed Corporation, Cleveland, Ohio), the Maverick (Medtronic, Dublin, Ireland), Kineflex (Spinal Motion, Mountainview, California), FlexiCore (Stryker, Kalamazoo, Michigan), LP-ESP (FH Orthopedics, Heimsbrunn, France), and M6-L (Orthofix, Lewisville, Texas) lumbar discs have either completed their trials, are actively ongoing or have been discontinued or withdrawn without FDA approval. All of these devices are available outside of the United States. Additionally, XL TDR (NuVasive, San Diego, California) and Triumph (Globus Medical, Audubon, Pennsylvania), which offered insertion techniques via lateral and posterior approaches, respectively, are only investigational at this point or available outside the United States 5).
The CHARITE and the PRODISC-L artificial disc do not present an additional hazard or risk to a patient undergoing an MRI procedure using a scanner operating with a static magnetic field of 1.5 T or lower. Image artefacts from the implants may present problems if the anatomical region of interest is in or near the area where these implants are located (e.g., vertebral canal at affected segment).
Unclassified
2: Yue JJ, Garcia R, Blumenthal S, Coric D, Patel VV, Dinh DH, Buttermann GR, Deutsch H, Miller LE, Persaud EJ, Ferko NC. Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease. Spine (Phila Pa 1976). 2019 Dec 15;44(24):1685-1696. doi: 10.1097/BRS.0000000000003171. PubMed PMID: 31404055.
3: Schwendicke F, Al-Abdi A, Pascual Moscardó A, Ferrando Cascales A, Sauro S. Remineralization effects of conventional and experimental ion-releasing materials in chemically or bacterially-induced dentin caries lesions. Dent Mater. 2019 May;35(5):772-779. doi: 10.1016/j.dental.2019.02.021. Epub 2019 Mar 8. PubMed PMID: 30853209.
4: Cui XD, Li HT, Zhang W, Zhang LL, Luo ZP, Yang HL. Mid- to long-term results of total disc replacement for lumbar degenerative disc disease: a systematic review. J Orthop Surg Res. 2018 Dec 26;13(1):326. doi: 10.1186/s13018-018-1032-6. PubMed PMID: 30585142; PubMed Central PMCID: PMC6306000.
5: Pettine K, Ryu R, Techy F. Why Lumbar Artificial Disk Replacements (LADRs) Fail. Clin Spine Surg. 2017 Jul;30(6):E743-E747. doi: 10.1097/BSD.0000000000000310. PubMed PMID: 28632563.
6: Onken J, Meyer B, Vajkoczy P. Surgical technique for revision surgery of cervical artificial disc replacements. Neurosurg Focus. 2017 Jan;42(VideoSuppl1):V3. doi: 10.3171/2017.1.FocusVid.16382. PubMed PMID: 28042721.
7: Onken J, Reinke A, Radke J, Finger T, Bayerl S, Vajkoczy P, Meyer B. Revision surgery for cervical artificial disc: Surgical technique and clinical results. Clin Neurol Neurosurg. 2017 Jan;152:39-44. doi: 10.1016/j.clineuro.2016.10.021. Epub 2016 Oct 31. PubMed PMID: 27888676.
8: Shein D, Shue J, Girardi F. Evaluation of Aesculap Implant Systems activl Artificial Disc for the treatment of degenerative disc disease. Expert Rev Med Devices. 2016 Dec;13(12):1069-1072. Epub 2016 Nov 22. Review. PubMed PMID: 27807981.
9: Yue JJ, Garcia R Jr, Miller LE. The activL(®) Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain. Med Devices (Auckl). 2016 May 10;9:75-84. doi: 10.2147/MDER.S102949. eCollection 2016. Review. PubMed PMID: 27274317; PubMed Central PMCID: PMC4869850.
10: Al-Abdi A, Paris S, Schwendicke F. Glass hybrid, but not calcium hydroxide, remineralized artificial residual caries lesions in vitro. Clin Oral Investig. 2017 Jan;21(1):389-396. doi: 10.1007/s00784-016-1803-6. Epub 2016 Apr 1. PubMed PMID: 27033226.
11: Hyde PJ, Fisher J, Hall RM. Wear characteristics of an unconstrained lumbar total disc replacement under a range of in vitro test conditions. J Biomed Mater Res B Appl Biomater. 2017 Jan;105(1):46-52. doi: 10.1002/jbm.b.33456. Epub 2015 Sep 28. PubMed PMID: 26411540; PubMed Central PMCID: PMC5215667.
12: Dreischarf M, Schmidt H, Putzier M, Zander T. Biomechanics of the L5-S1 motion segment after total disc replacement - Influence of iatrogenic distraction, implant positioning and preoperative disc height on the range of motion and loading of facet joints. J Biomech. 2015 Sep 18;48(12):3283-91. doi: 10.1016/j.jbiomech.2015.06.023. Epub 2015 Jul 2. PubMed PMID: 26184587.
13: Käfer W, Cakir B, Midderhoff S, Reichel H, Wilke HJ. Circumferential dynamic stabilization of the lumbar spine: a biomechanical analysis. Eur Spine J. 2014 Nov;23(11):2330-9. doi: 10.1007/s00586-014-3286-y. Epub 2014 Apr 11. PubMed PMID: 24722881.
14: Guyer RD, Pettine K, Roh JS, Dimmig TA, Coric D, McAfee PC, Ohnmeiss DD. 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). 2014 May 20;39(12):925-31. doi: 10.1097/BRS.0000000000000319. PubMed PMID: 24718066.
15: Rohlmann A, Lauterborn S, Dreischarf M, Schmidt H, Putzier M, Strube P, Zander T. Parameters influencing the outcome after total disc replacement at the lumbosacral junction. Part 1: misalignment of the vertebrae adjacent to a total disc replacement affects the facet joint and facet capsule forces in a probabilistic finite element analysis. Eur Spine J. 2013 Oct;22(10):2271-8. doi: 10.1007/s00586-013-2909-z. Epub 2013 Jul 20. PubMed PMID: 23868223; PubMed Central PMCID: PMC3804691.
16: Scott-Young MN, Lee MJ, Nielsen DEA, Magno CL, Kimlin KR, Mitchell EO. Clinical and Radiological Mid-Term Outcomes of Lumbar Single-Level Total Disc Replacement. Spine (Phila Pa 1976). 2018 Jan 15;43(2):105-113. doi: 10.1097/BRS.0b013e3182345aa2. PubMed PMID: 21912307.
17: Pettine K, Hersh A. Kineflex lumbar artificial disc versus Charité lumbar total disc replacement for the treatment of degenerative disc disease: A randomized non-inferiority trial with minimum of 2 years' follow-up. SAS J. 2011 Dec 1;5(4):108-13. doi: 10.1016/j.esas.2011.07.003. eCollection 2011. PubMed PMID: 25802676; PubMed Central PMCID: PMC4365632.
18: Liu YC, Xia Q, Zhang JD, Xu BS, Hu YC, Ji N, Miao J, Bai JQ, Han Y, Ning SL, Yang Q. [Effect of intervertebral position on range of motion after artificial lumbar total disc replacement and clinical management]. Zhonghua Yi Xue Za Zhi. 2010 Oct 26;90(39):2750-4. Chinese. PubMed PMID: 21162910.
19: Katsimihas M, Bailey CS, Issa K, Fleming J, Rosas-Arellano P, Bailey SI, Gurr KR. 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. 2010 Dec;53(6):408-4145. PubMed PMID: 21092434; PubMed Central PMCID: PMC2993028.
20: Kim KT, Lee SH, Suk KS, Lee JH, Jeong BO. Biomechanical changes of the lumbar segment after total disc replacement : charite®, prodisc® and maverick® using finite element model study. J Korean Neurosurg Soc. 2010 Jun;47(6):446-53. doi: 10.3340/jkns.2010.47.6.446. Epub 2010 Jun 30. PubMed PMID: 20617091; PubMed Central PMCID: PMC2899033.
21: van den Eerenbeemt KD, Ostelo RW, van Royen BJ, Peul WC, van Tulder MW. Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature. Eur Spine J. 2010 Aug;19(8):1262-80. doi: 10.1007/s00586-010-1445-3. Epub 2010 May 28. Review. PubMed PMID: 20508954; PubMed Central PMCID: PMC2989191.
22: Yue JJ, Mo FF. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease. BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14. PubMed PMID: 20380708; PubMed Central PMCID: PMC2858130.
23: Guyer RD. Re: “prospective, randomized multicenter Food and Drug Administration investigational device exemption study of lumbar tool disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up”. Spine J. 2010 Apr;10(4):360; author reply 361-3. doi: 10.1016/j.spinee.2009.10.009. PubMed PMID: 20362255.
24: Schmidt H, Galbusera F, Rohlmann A, Zander T, Wilke HJ. Effect of multilevel lumbar disc arthroplasty on spine kinematics and facet joint loads in flexion and extension: a finite element analysis. Eur Spine J. 2012 Jun;21 Suppl 5:S663-74. doi: 10.1007/s00586-010-1382-1. Epub 2010 Apr 2. PubMed PMID: 20361341; PubMed Central PMCID: PMC3377807.
25: Fayssoux R, Goldfarb NI, Vaccaro AR, Harrop J. Indirect costs associated with surgery for low back pain-a secondary analysis of clinical trial data. Popul Health Manag. 2010 Feb;13(1):9-13. doi: 10.1089/pop.2009.0061. PubMed PMID: 20158318.
26: Pimenta L, Springmuller R, Lee CK, Oliveira L, Roth SE, Ogilvie WF. Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up. SAS J. 2010 Mar 1;4(1):16-25. doi: 10.1016/j.esas.2009.12.002. eCollection 2010. PubMed PMID: 25802645; PubMed Central PMCID: PMC4365609.
27: Zander T, Krishnakanth P, Bergmann G, Rohlmann A. Diurnal variations in intervertebral disc height affect spine flexibility, intradiscal pressure and contact compressive forces in the facet joints. Comput Methods Biomech Biomed Engin. 2010 Oct;13(5):551-7. doi: 10.1080/10255840903337855. PubMed PMID: 19937492.
28: Gottfried ON, Brodke DS. Traumatic burst fracture in a patient with a lumbar artificial disc. J Neurosurg Spine. 2009 Sep;11(3):353-7. doi: 10.3171/2009.3.SPINE08902. PubMed PMID: 19769519.
29: Schmidt H, Midderhoff S, Adkins K, Wilke HJ. The effect of different design concepts in lumbar total disc arthroplasty on the range of motion, facet joint forces and instantaneous center of rotation of a L4-5 segment. Eur Spine J. 2009 Nov;18(11):1695-1705. doi: 10.1007/s00586-009-1146-y. PubMed PMID: 19763638; PubMed Central PMCID: PMC2899406.
30: Kim SH, Chang UK, Chang JC, Chun KS, Lim TJ, Kim DH. The Changes in Range of Motion after a Lumbar Spinal Arthroplasty with Charité in the Human Cadaveric Spine under Physiologic Compressive Follower Preload : A Comparative Study between Load Control Protocol and Hybrid Protocol. J Korean Neurosurg Soc. 2009 Aug;46(2):144-51. doi: 10.3340/jkns.2009.46.2.144. Epub 2009 Aug 31. PubMed PMID: 19763217; PubMed Central PMCID: PMC2744024.
31: Rosen C, Kiester PD, Lee TQ. Lumbar disk replacement failures: review of 29 patients and rationale for revision. Orthopedics. 2009 Aug;32(8). pii: orthosupersite.com/view.asp?rID=41919. doi: 10.3928/01477447-20090624-08. PubMed PMID: 19708630.
32: de Maat GH, Punt IM, van Rhijn LW, Schurink GW, van Ooij A. Removal of the Charité lumbar artificial disc prosthesis: surgical technique. J Spinal Disord Tech. 2009 Jul;22(5):334-9. doi: 10.1097/BSD.0b013e3181761d0c. PubMed PMID: 19525788.
33: Yang CW, Liu L, Wang J, Dong AS, Lu JP, He SS, Li M. Magnetic resonance imaging of artificial lumbar disks: safety and metal artifacts. Chin Med J (Engl). 2009 Apr 20;122(8):911-6. PubMed PMID: 19493413.
34: Chung SK, Kim YE, Wang KC. Biomechanical effect of constraint in lumbar total disc replacement: a study with finite element analysis. Spine (Phila Pa 1976). 2009 May 20;34(12):1281-6. doi: 10.1097/BRS.0b013e3181a4ec2d. PubMed PMID: 19455003.
35: Rauschmann MA, Thalgott J, Fogarty M, Nichlos M, Kleinszig G, Knap M, Kafchitsas K. Insertion of the artificial disc replacement: a cadaver study comparing the conventional surgical technique and the use of a navigation system. Spine (Phila Pa 1976). 2009 May 1;34(10):1110-5. doi: 10.1097/BRS.0b013e31819e2235. PubMed PMID: 19404182.
36: Di Silvestre M, Bakaloudis G, Lolli F, Vommaro F, Parisini P. Two-level total lumbar disc replacement. Eur Spine J. 2009 Jun;18 Suppl 1:64-70. doi: 10.1007/s00586-009-0982-0. Epub 2009 Apr 28. PubMed PMID: 19399536; PubMed Central PMCID: PMC2899615.
37: Zander T, Rohlmann A, Bergmann G. Influence of different artificial disc kinematics on spine biomechanics. Clin Biomech (Bristol, Avon). 2009 Feb;24(2):135-42. doi: 10.1016/j.clinbiomech.2008.11.008. Epub 2009 Jan 3. PubMed PMID: 19121822.
38: Geisler FH, McAfee PC, Banco RJ, Blumenthal SL, Guyer RD, Holt RT, Majd ME. Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty. SAS J. 2009 Mar 1;3(1):17-25. doi: 10.1016/SASJ-2008-0019-RR. eCollection 2009. PubMed PMID: 25802625; PubMed Central PMCID: PMC4365588.
39: Rohlmann A, Mann A, Zander T, Bergmann G. Effect of an artificial disc on lumbar spine biomechanics: a probabilistic finite element study. Eur Spine J. 2009 Jan;18(1):89-97. doi: 10.1007/s00586-008-0836-1. Epub 2008 Nov 29. PubMed PMID: 19043744; PubMed Central PMCID: PMC2615124.
40: Guyer RD, McAfee PC, Banco RJ, Bitan FD, Cappuccino A, Geisler FH, Hochschuler SH, Holt RT, Jenis LG, Majd ME, Regan JJ, Tromanhauser SG, Wong DC, Blumenthal SL. 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 May;9(5):374-86. doi: 10.1016/j.spinee.2008.08.007. Epub 2008 Sep 19. PubMed PMID: 18805066.
41: Warachit P. Results of Charité artificial lumbar disc replacement: experience in 43 Thais. J Med Assoc Thai. 2008 Aug;91(8):1212-7. PubMed PMID: 18788693.
42: Jeon SH, Choi WG, Lee SH. Anterior revision of a dislocated ProDisc prosthesis at the L4-5 level. J Spinal Disord Tech. 2008 Aug;21(6):448-50. doi: 10.1097/BSD.0b013e3181633a32. PubMed PMID: 18679102.
43: Petilon J, Hardenbrook M, Sukovich W. The effect of parallax on intraoperative positioning of the Charité artificial disc. J Spinal Disord Tech. 2008 Aug;21(6):422-9. doi: 10.1097/BSD.0b013e31815708a6. PubMed PMID: 18679098.
44: Kosmopoulos V, Stafylas K, McManus J, Schizas C. Radiographic total disc replacement angle measurement accuracy using the Oxford Cobbometer: precision and bias. Eur Spine J. 2008 Aug;17(8):1066-72. doi: 10.1007/s00586-008-0686-x. Epub 2008 May 22. PubMed PMID: 18496719; PubMed Central PMCID: PMC2518759.
45: Moreno P, Boulot J. [Comparative study of short-term results between total artificial disc prosthesis and anterior lumbar interbody fusion]. Rev Chir Orthop Reparatrice Appar Mot. 2008 May;94(3):282-8. doi: 10.1016/j.rco.2007.12.011. Epub 2008 Mar 10. French. PubMed PMID: 18456064.
46: Rohlmann A, Zander T, Bock B, Bergmann G. Effect of position and height of a mobile core type artificial disc on the biomechanical behaviour of the lumbar spine. Proc Inst Mech Eng H. 2008 Feb;222(2):229-39. PubMed PMID: 18441758.
47: Geisler FH, Guyer RD, Blumenthal SL, McAfee PC, Cappuccino A, Bitan F, Regan JJ. Effect of previous surgery on clinical outcome following 1-level lumbar arthroplasty. J Neurosurg Spine. 2008 Feb;8(2):108-14. doi: 10.3171/SPI/2008/8/2/108. PubMed PMID: 18248281.
48: Guyer RD, Geisler FH, Blumenthal SL, McAfee PC, Mullin BB. Effect of age on clinical and radiographic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up. J Neurosurg Spine. 2008 Feb;8(2):101-7. doi: 10.3171/SPI/2008/8/2/101. PubMed PMID: 18248280.
49: Cunningham BW, McAfee PC, Geisler FH, Holsapple G, Adams K, Blumenthal SL, Guyer RD, Cappuccino A, Regan JJ, Fedder IL, Tortolani PJ. Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion. J Neurosurg Spine. 2008 Jan;8(1):7-12. doi: 10.3171/SPI-08/01/007. PubMed PMID: 18173340.
50: Punt IM, Visser VM, van Rhijn LW, Kurtz SM, Antonis J, Schurink GW, van Ooij A. Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients. Eur Spine J. 2008 Jan;17(1):36-43. Epub 2007 Oct 10. PubMed PMID: 17929065; PubMed Central PMCID: PMC2226059.
51: van Ooij A, Schurink GW, Oner FC, Verbout AJ. [Findings in 67 patients with recurrent or persistent symptoms after implantation of a disc prosthesis for low back pain]. Ned Tijdschr Geneeskd. 2007 Jul 14;151(28):1577-84. Dutch. PubMed PMID: 17715768.
52: Guyer RD, Tromanhauser SG, Regan JJ. An economic model of one-level lumbar arthroplasty versus fusion. Spine J. 2007 Sep-Oct;7(5):558-62. Epub 2006 Dec 22. PubMed PMID: 17588819.
53: Leary SP, Regan JJ, Lanman TH, Wagner WH. Revision and explantation strategies involving the CHARITE lumbar artificial disc replacement. Spine (Phila Pa 1976). 2007 Apr 20;32(9):1001-11. PubMed PMID: 17450076.
54: Panjabi M, Malcolmson G, Teng E, Tominaga Y, Henderson G, Serhan H. Hybrid testing of lumbar CHARITE discs versus fusions. Spine (Phila Pa 1976). 2007 Apr 20;32(9):959-66; discussion 967. PubMed PMID: 17450069.
55: David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine (Phila Pa 1976). 2007 Mar 15;32(6):661-6. PubMed PMID: 17413471.
56: Geisler FH. The CHARITE Artificial Disc: design history, FDA IDE study results, and surgical technique. Clin Neurosurg. 2006;53:223-8. Review. PubMed PMID: 17380756.
57: Zander T, Rohlmann A, Bock B, Bergmann G. [Biomechanical consequences of variations in artificial disc positioning. A finite element study on the lumbar spine]. Orthopade. 2007 Mar;36(3):205-6, 208-11. German. PubMed PMID: 17333069.
58: van Ooij A, Kurtz SM, Stessels F, Noten H, van Rhijn L. Polyethylene wear debris and long-term clinical failure of the Charité disc prosthesis: a study of 4 patients. Spine (Phila Pa 1976). 2007 Jan 15;32(2):223-9. Erratum in: Spine. 2007 Apr 20;32(9):1052. PubMed PMID: 17224818.
59: Tortolani PJ, Cunningham BW, Eng M, McAfee PC, Holsapple GA, Adams KA. Prevalence of heterotopic ossification following total disc replacement. A prospective, randomized study of two hundred and seventy-six patients. J Bone Joint Surg Am. 2007 Jan;89(1):82-8. PubMed PMID: 17200314.
60: Holt RT, Majd ME, Isaza JE, Blumenthal SL, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Garcia R Jr, Regan JJ. Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc. SAS J. 2007 Feb 1;1(1):20-7. doi: 10.1016/SASJ-2006-0004-RR. eCollection 2007. PubMed PMID: 25802575; PubMed Central PMCID: PMC4365564.
61: Geisler FH. Surgical treatment for discogenic low-back pain: lumbar arthroplasty results in superior pain reduction and disability level improvement compared with lumbar fusion. SAS J. 2007 Feb 1;1(1):12-9. doi: 10.1016/SASJ-2006-0002-RR. eCollection 2007. PubMed PMID: 25802574; PubMed Central PMCID: PMC4365567.
62: Blumenthal SL, Guyer RD, Geisler FH, McAfee PC, Regan JJ. The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment. SAS J. 2007 Feb 1;1(1):8-11. doi: 10.1016/SASJ-2006-0001-RR. eCollection 2007. PubMed PMID: 25802573; PubMed Central PMCID: PMC4365565.
63: Pimenta L, Díaz RC, Guerrero LG. Charité lumbar artificial disc retrieval: use of a lateral minimally invasive technique. Technical note. J Neurosurg Spine. 2006 Dec;5(6):556-61. PubMed PMID: 17176025.
64: Wagner WH, Regan JJ, Leary SP, Lanman TH, Johnson JP, Rao RK, Cossman DV. Access strategies for revision or explantation of the Charité lumbar artificial disc replacement. J Vasc Surg. 2006 Dec;44(6):1266-72. PubMed PMID: 17145428.
65: Grauer JN, Biyani A, Faizan A, Kiapour A, Sairyo K, Ivanov A, Ebraheim NA, Patel TCh, Goel VK. Biomechanics of two-level Charité artificial disc placement in comparison to fusion plus single-level disc placement combination. Spine J. 2006 Nov-Dec;6(6):659-66. Epub 2006 Oct 10. PubMed PMID: 17088196.
66: Regan JJ, McAfee PC, Blumenthal SL, Guyer RD, Geisler FH, Garcia R Jr, Maxwell JH. Evaluation of surgical volume and the early experience with lumbar total disc replacement as part of the investigational device exemption study of the Charité Artificial Disc. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2270-6. PubMed PMID: 16946666.
67: Serhan HA, Dooris AP, Parsons ML, Ares PJ, Gabriel SM. In vitro wear assessment of the Charité Artificial Disc according to ASTM recommendations. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1900-10. PubMed PMID: 16924206.
68: Freeman BJ, Davenport J. Total disc replacement in the lumbar spine: a systematic review of the literature. Eur Spine J. 2006 Aug;15 Suppl 3:S439-47. Epub 2006 Jul 22. Review. PubMed PMID: 16862432; PubMed Central PMCID: PMC2335389.
69: McAfee PC, Geisler FH, Saiedy SS, Moore SV, Regan JJ, Guyer RD, Blumenthal SL, Fedder IL, Tortolani PJ, Cunningham B. 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). 2006 May 15;31(11):1217-26. PubMed PMID: 16688035.
70: Herkowitz HN. Total disc replacement with the CHARITE artificial disc was as effective as lumbar interbody fusion. J Bone Joint Surg Am. 2006 May;88(5):1168. PubMed PMID: 16651606.
71: Liu J, Ebraheim NA, Haman SP, Shafiq Q, Karkare N, Biyani A, Goel VK, Woldenberg L. Effect of the increase in the height of lumbar disc space on facet joint articulation area in sagittal plane. Spine (Phila Pa 1976). 2006 Apr 1;31(7):E198-202. PubMed PMID: 16582840.
72: Petersilge CA. Lumbar disc replacement. Semin Musculoskelet Radiol. 2006 Mar;10(1):22-9. Review. PubMed PMID: 16514578.
73: SariAli el-H, Lemaire JP, Pascal-Mousselard H, Carrier H, Skalli W. In vivo study of the kinematics in axial rotation of the lumbar spine after total intervertebral disc replacement: long-term results: a 10-14 years follow up evaluation. Eur Spine J. 2006 Oct;15(10):1501-10. Epub 2006 Jan 21. PubMed PMID: 16429293.
74: Goel VK, Grauer JN, Patel TCh, Biyani A, Sairyo K, Vishnubhotla S, Matyas A, Cowgill I, Shaw M, Long R, Dick D, Panjabi MM, Serhan H. Effects of charité artificial disc on the implanted and adjacent spinal segments mechanics using a hybrid testing protocol. Spine (Phila Pa 1976). 2005 Dec 15;30(24):2755-64. PubMed PMID: 16371899.
75: Aryan HE, Acosta FL Jr, Ames CP. The Charité Artificial Disc: insertion technique. Neurosurg Clin N Am. 2005 Oct;16(4):637-50, vii. PubMed PMID: 16326287.
76: Putzier M, Funk JF, Schneider SV, Gross C, Tohtz SW, Khodadadyan-Klostermann C, Perka C, Kandziora F. Charité total disc replacement–clinical and radiographical results after an average follow-up of 17 years. Eur Spine J. 2006 Feb;15(2):183-95. Epub 2005 Oct 28. PubMed PMID: 16254716; PubMed Central PMCID: PMC3489410.
77: Trouillier H, Kern P, Refior HJ, Müller-Gerbl M. A prospective morphological study of facet joint integrity following intervertebral disc replacement with the CHARITE Artificial Disc. Eur Spine J. 2006 Feb;15(2):174-82. Epub 2005 Sep 7. PubMed PMID: 16151716; PubMed Central PMCID: PMC3489407.
78: McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J. 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). 2005 Jul 15;30(14):1576-83; discussion E388-90. PubMed PMID: 16025025.
79: Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD. 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 Jul 15;30(14):1565-75; discussion E387-91. Erratum in: Spine. 2005 Oct 15;30(20):2356. PubMed PMID: 16025024.
80: Lemaire JP, Carrier H, Sariali el-H, Skalli W, Lavaste F. Clinical and radiological outcomes with the Charité artificial disc: a 10-year minimum follow-up. J Spinal Disord Tech. 2005 Aug;18(4):353-9. Erratum in: J Spinal Disord Tech. 2006 Feb;19(1):76. Sari Ali, El-Hadi [corrected to Sariali, El-hadi]. PubMed PMID: 16021017.
81: Krämer J, Kleinert H, Senge A, Rubenthaler F. [Artificial discs: review, current status, outlook]. Z Orthop Ihre Grenzgeb. 2005 May-Jun;143(3):281-6. Review. German. PubMed PMID: 15977115.
82: Regan JJ. Clinical results of charité lumbar total disc replacement. Orthop Clin North Am. 2005 Jul;36(3):323-40. Review. PubMed PMID: 15950692.
83: Errico TJ. Lumbar disc arthroplasty. Clin Orthop Relat Res. 2005 Jun;(435):106-17. Review. PubMed PMID: 15930927.
84: Rohlmann A, Zander T, Bergmann G. Effect of total disc replacement with ProDisc on intersegmental rotation of the lumbar spine. Spine (Phila Pa 1976). 2005 Apr 1;30(7):738-43. PubMed PMID: 15803074.
85: Geisler FH. Surgical technique of lumbar artificial disc replacement with the Charité artificial disc. Neurosurgery. 2005 Jan;56(1 Suppl):46-57; discussion 46-57. PubMed PMID: 15799792.
86: David T. Revision of a Charité artificial disc 9.5 years in vivo to a new Charité artificial disc: case report and explant analysis. Eur Spine J. 2005 Jun;14(5):507-11. Epub 2005 Jan 26. PubMed PMID: 15672241; PubMed Central PMCID: PMC3454668.
87: Guyer RD, McAfee PC, Hochschuler SH, Blumenthal SL, Fedder IL, Ohnmeiss DD, Cunningham BW. Prospective randomized study of the Charite artificial disc: data from two investigational centers. Spine J. 2004 Nov-Dec;4(6 Suppl):252S-259S. PubMed PMID: 15541674.
88: Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004 Sep;1(2):143-54. PubMed PMID: 15346999.
89: McAfee PC, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW. Experimental design of total disk replacement-experience with a prospective randomized study of the SB Charitè. Spine (Phila Pa 1976). 2003 Oct 15;28(20):S153-62. PubMed PMID: 14560186.
90: McAfee PC, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW. SB Charité disc replacement: report of 60 prospective randomized cases in a US center. J Spinal Disord Tech. 2003 Aug;16(4):424-33. PubMed PMID: 12902960.
91: van Ooij A, Oner FC, Verbout AJ. Complications of artificial disc replacement: a report of 27 patients with the SB Charité disc. J Spinal Disord Tech. 2003 Aug;16(4):369-83. PubMed PMID: 12902953.
92: Peroz I, Tai S. Masticatory performance in patients with anterior disk displacement without reduction in comparison with symptom-free volunteers. Eur J Oral Sci. 2002 Oct;110(5):341-4. PubMed PMID: 12664463.
93: Caspi I, Levinkopf M, Nerubay J. Results of lumbar disk prosthesis after a follow-up period of 48 months. Isr Med Assoc J. 2003 Jan;5(1):9-11. PubMed PMID: 12592949.
94: Büttner-Janz K. Optimal minimally traumatic approach for the SB Charité Artificial Disc. Eur Spine J. 2002 Oct;11 Suppl 2:S111-4. Epub 2002 Sep 6. Review. PubMed PMID: 12384731; PubMed Central PMCID: PMC3611579.
95: Hochschuler SH, Ohnmeiss DD, Guyer RD, Blumenthal SL. Artificial disc: preliminary results of a prospective study in the United States. Eur Spine J. 2002 Oct;11 Suppl 2:S106-10. Epub 2002 Sep 13. PubMed PMID: 12384730; PubMed Central PMCID: PMC3611580.
96: Link HD. History, design and biomechanics of the LINK SB Charité artificial disc. Eur Spine J. 2002 Oct;11 Suppl 2:S98-S105. Epub 2002 Sep 5. PubMed PMID: 12384729; PubMed Central PMCID: PMC3611577.
97: Hopf C, Heeckt H, Beske C. [Disc replacement with the SB Charité endoposthesis - experience, preliminary results and comments after 35 prospectively performed operations]. Z Orthop Ihre Grenzgeb. 2002 Sep-Oct;140(5):485-91. German. PubMed PMID: 12226770.
98: Büttner-Janz K, Hahn S, Schikora K, Link HD. [Basic principles of successful implantation of the SB Charité model LINK intervertebral disk endoprosthesis]. Orthopade. 2002 May;31(5):441-53. German. PubMed PMID: 12089793.
99: Zeegers WS, Bohnen LM, Laaper M, Verhaegen MJ. Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients. Eur Spine J. 1999;8(3):210-7. PubMed PMID: 10413347; PubMed Central PMCID: PMC3611160.
100: Cinotti G, David T, Postacchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine (Phila Pa 1976). 1996 Apr 15;21(8):995-1000. PubMed PMID: 8726204.
101: Griffith SL, Shelokov AP, Büttner-Janz K, LeMaire JP, Zeegers WS. A multicenter retrospective study of the clinical results of the LINK SB Charité intervertebral prosthesis. The initial European experience. Spine (Phila Pa 1976). 1994 Aug 15;19(16):1842-9. PubMed PMID: 7973983.
102: Wendt MO, Pohl M, Pratsch S, Lerche D. In vitro hemolysis by mechanical heart valve prostheses with tilting disc. Int J Artif Organs. 1992 Nov;15(11):681-5. PubMed PMID: 1490762.
103: Pohl M, Wendt MO, Lerche D. [Hydrodynamic in vitro comparison of a new artificial heart valve with the Björk-Shiley valve (standard)]. Biomed Tech (Berl). 1991 Jun;36(6):134-9. German. PubMed PMID: 1883926.