LUMBAR DISC REPLACEMENTS
CHARITE
METHOD: Pubmed, the world largest data base of medical publications, was searched for all studies pertaining to the Charite Artificial Disc. Our evaluation is based exclusively on the therapeutic analyses studies which appear in peer reviewed English language publications. Repetitive publication of identical results and data were not included.
TOTAL: 20 CHARITE STUDIES
14 Studies
4 Studies
2 Studies
2 Level I
12 Level IV
1 Level I
3 Level IV
2 Level IV
>25% of studies (85%) are Level IV
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LUMBAR DISC REPLACEMENTS
PRODISC
METHOD: Pubmed, the world largest data base of medical publications, was searched for all studies pertaining to the Prodisc Artificial Disc. Our evaluation is based exclusively on the therapeutic analyses studies which appear in peer reviewed English language publications. Repetitive publication of identical results and data were not included.
TOTAL: 12 PRODISC STUDIES
11 Studies
1 Study
0 Studies
11 Level IV
1 Level IV
>25% of studies (92%) are Level IV
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LUMBAR DISC REPLACEMENTS
MAVERICK
METHOD: Pubmed, the world largest data base of medical publications, was searched for all studies pertaining to the Maverick Artificial Disc. Our evaluation is based exclusively on the therapeutic analyses studies which appear in peer reviewed English language publications. Repetitive publication of identical results and data were not included.
TOTAL: 10 MAVERICK STUDIES
7 Studies
3 Studies
0 Studies
6 Level IV
1 Level V
1 Level II
2 Level IV
>25% of favorable studies are Level IV which is the preponderance of data
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CHARITE:
Studies Favorable: Total 14
Level I: 2 Studies
1. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes.
McAfee PC, Cunningham B, Holsapple G, Adams K, et al.
Spine 2005;30:1576-83.
Level I – Favorable
2. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes.
Blumenthal S, McAfee PC, Guyer RD, et al.
Spine 2005;30:1565-75
Level I – Favorable
Level IV: 12 Studies
1. The prevalence of contraindications to total disc replacement in a cohort of lumbar surgical patients.
Huang RC, Lim MR, Girardi FP, Cammisa FP Jr.
Spine 2004;29:2538-41.
Level IV – Favorable
Case series with historical control.
2. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ artificial disc in 106 patients.
David T.
Spine 2007;32:661-6.
Level IV – Favorable
3. Computed tomography assessment of the accuracy of in vivo placement of artificial discs in the lumbar spine including radiographic and clinical consequences.
Patel VV, Andrews C, Pradhan BB, et al.
Spine 2006;31:948-53
Level IV – Favorable
Prospective case series without control
4. Clinical and radiological outcomes with the Charité trade mark artificial disc: a 10-year minimum follow-up.
Lemaire JP, Carrier H, Ali el-HS, et al.
J Spinal Disord Tech 2005;18:353-9.
Level IV – Favorable
5. Range of motion and adjacent level degeneration after lumbar total disc replacement.
Huang RC, Tropiano P, Marnay T, et al.
Spine J 2006;6:242-7.
Level IV – Favorable
6. A prospective morphological study of facet joint integrity following intervertebral disc replacement with the CHARITÉ Artificial Disc.
Trouillier H, Kern P, Refior HJ, Muller-Gerbl M.
Eur Spine J 2006;15:174-82.
Level IV – Favorable
7. Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients.
Zeegers WS, Bohnen LM, Laaper M, Verhaegen MJ.
Eur Spine J 1999;8:210-7.
Level IV – Favorable
8. Clinical results of Charité lumbar total disc replacement.
Regan JJ.
Orthop Clin North Am 2005;36:323-40
Level IV – Favorable
9. Increasing age does not affect good outcome after lumbar disc replacement.
Sott AH, Harrison DJ.
Int Orthop 2000;24:50-3
Level IV – Favorable
10. Prevalence of heterotopic ossification following total disc replacement. A prospective, randomized study of two hundred and seventy-six patients.
Tortolani PJ, Cunningham BW, Eng M, et al.
J Bone Joint Surg Am 2007;89:82
Level IV – Favorable
Case series observing incidence of Heterotopic ossification
11. Minimally invasive total disc replacement: surgical technique and preliminary clinical results.
Mayer HM, Wiechert K, Korge A, Qose I.
Eur Spine J 2002;11(Suppl 2):S124-30
Level IV – Favorable
12. Intervertebral disc prosthesis. Results and prospects for the year 2000.
Lemaire JP, Skalli W, Lavaste F, et al.
Clin Orthop Relat Res 1997;337:64-76
Level IV – Favorable
CHARITE:
Studies Unfavorable: Total 4
Level I: 1 Study
1. Point of view: commentary on the research reports that led to food and drug administration approval of an artificial disc.
Mirza SK.
Spine 2005;30:1561-4
Level I – Unfavorable
Systematic review of Level I studies
Level IV: 3 Studies
1. An Evidence-Based Medicine Approach in Determining Factors That May Affect Outcome in Lumbar Total Disc Replacement [Literature Review]
Zindrick, Michael R. MD*†; Tzermiadianos, Michael N. MD†; Voronov, Leonard I. MD†; Lorenz, Mark MD*; Hadjipavlou, Alexander MD‡
Spine:Volume 33(11)15 May 2008pp 1262-1269
Review of all ADR literature reveals majority are Level IV and do not provide sufficient evidence to support performing ADR’s
Level IV – Unfavorable
2. Charité versus ProDisc: a comparative study of a minimum 3-year follow-up.
Shim CS, Lee SH, Shin HD, et al.
Spine 2007;32:1012-8.
Level IV – Unfavorable
3. Complications of artificial disc replacement: a report of 27 patients with the SB Charité disc.
van Ooij A, Oner FC, Verbout AJ.
J Spinal Disord Tech 2003;16:369-83.
Level IV – Unfavorable
CHARITE:
Studies Neutral: Total 2
Level IV: 2 Studies
1. Results of disc prosthesis after a minimum follow-up period of 2 years.
Cinotti G, David T, Postacchini F.
Spine 1996;21:995-1000.
Level IV – Neutral
2. Correlation between range of motion and outcome after lumbar total disc replacement: 8.6-year follow-up.
Huang RC, Girardi FP, Cammisa FP Jr, et al.
Spine 2005;30:1407-11
Level IV – Neutral
PRODISC:
Studies Favorable: Total 11
Level IV: 11 Studies
1. 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.
Zigler J, Delamarter R, Spivak JM, et al.
Spine 2007;32:1155-63.
Level IV – Favorable
2. Total lumbar disc replacement: different results for different levels.
Siepe CJ, Mayer HM, Heinz-Leisenheimer M, Korge A.
Spine 2007;32:782-90.
Level IV – Favorable
3. Clinical results of total lumbar disc replacement with ProDisc II: three-year results for different indications.
Siepe CJ, Mayer HM, Wiechert K, Korge A.
Spine 2006;31:1923-32
Level IV – Favorable
4. The treatment of disabling single-level lumbar discogenic low back pain with total disc arthroplasty utilizing the Prodisc prosthesis: a prospective study with 2-year minimum follow-up.
Bertagnoli R, Yue JJ, Shah RV, et al.
Spine 2005;30:2230-6
Level IV – Favorable
5. The treatment of disabling multilevel lumbar discogenic low back pain with total disc arthroplasty utilizing the ProDisc prosthesis: a prospective study with 2-year minimum follow-up.
Bertagnoli R, Yue JJ, Shah RV, et al.
Spine 2005;30:2192-9.
Level IV – Favorable
6. Lumbar total disc replacement using ProDisc II: a prospective study with a 2-year minimum follow-up.
Chung SS, Lee CS, Kang CS.
J Spinal Disord Tech 2006;19:411-5
Level IV – Favorable
7. Lumbar disc replacement: preliminary results with ProDisc II after a minimum follow-up period of 1 year.
Tropiano P, Huang RC, Girardi FP, Marnay T.
J Spinal Disord Tech 2003;16:362-8
Level IV – Favorable
8. Charité total disc replacement-clinical and radiographical results after an average follow-up of 17 years.
Putzier M, Funk JF, Schneider SV, Gross C, et al.
Eur Spine J 2006;15:183-95
Level IV – Favorable
9. Lumbar total disc arthroplasty in patients older than 60 years of age: a prospective study of the ProDisc prosthesis with 2-year minimum follow-up period.
Bertagnoli R, Yue JJ, Nanieva R, et al.
J Neurosurg Spine 2006;4:85-90.
Level IV – Favorable
10. Indications for full prosthetic disc arthroplasty: a correlation of clinical outcome against a variety of indications.
Bertagnoli R, Kumar S.
Eur Spine J 2002;11(Suppl 2):S131-6.
Level IV – Favorable
11. Lumbar total disc replacement. Seven to eleven-year follow-up.
Tropiano P, Huang RC, Girardi FP, et al.
J Bone Joint Surg Am 2005;87:490-6.
Level IV – Favorable
PRODISC:
Studies Unfavorable: Total 1
Level IV: 1 Study
1. Charité versus ProDisc: a comparative study of a minimum 3-year follow-up.
Shim CS, Lee SH, Shin HD, et al.
Spine 2007;32:1012-8.
Level IV – Unfavorable
MAVERICK LUMBAR DISC REPLACEMENT
Studies Favorable: Total 6
Level IV: 6 Studies
1. Subsidence and malplacement with the Oblique Maverick Lumbar Disc Arthroplasty: technical note.
Marshman LA, Friesem T, Rampersaud YR, Le Huec JC, Krishna M.
Spine J. 2008 Jul-Aug;8(4):650-5. Epub 2007 May 22.
Level IV – Favorable
Related Articles
2. Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement.
Tournier C, Aunoble S, Le Huec JC, Lemaire JP, Tropiano P, Lafage V, Skalli W.
Eur Spine J. 2007 Mar;16(3):411-21. Epub 2006 Sep 8.
Level IV – Favorable
Case series of Maverick, Charite, Prodisc
3. Clinical results of Maverick lumbar total disc replacement: two-year prospective follow-up.
Le Huec JC, Mathews H, Basso Y, Aunoble S, Hoste D, Bley B, Friesem T.
Orthop Clin North Am. 2005 Jul;36(3):315-22.
Level IV – Favorable
Related Articles
4. Influence of facet and posterior muscle degeneration on clinical results of lumbar total disc replacement: two-year follow-up.
Le Huec JC, Basso Y, Aunoble S, Friesem T, Bruno MB.
J Spinal Disord Tech. 2005 Jun;18(3):219-23.
Level IV – Favorabel
Related Articles
5. The effect of single-level, total disc arthroplasty on sagittal balance parameters: a prospective study.
Le Huec J, Basso Y, Mathews H, Mehbod A, Aunoble S, Friesem T, Zdeblick T.
Eur Spine J. 2005 Jun;14(5):480-6. Epub 2005 Mar 11.
Level IV – Favorable
6. Design rationale and biomechanics of Maverick Total Disc arthroplasty with early clinical results.
Mathews HH, Lehuec JC, Friesem T, Zdeblick T, Eisermann L.
Spine J. 2004 Nov-Dec;4(6 Suppl):268S-275S. Review.
Level IV – Favorable
Case series with historical control
Related Articles
Level V: 1 Study
1. Lumbar disc arthroplasty.
Errico TJ.
Clin Orthop Relat Res. 2005 Jun;(435):106-17. Review.
Level V – Favorable
Related Articles
MAVERICK LUMBAR DISC REPLACEMENT
Studies Unfavorable: Total 3
Level II: 1 Study
1. Release of cobalt and chromium ions into the serum following implantation of the metal-on-metal Maverick-type artificial lumbar disc (Medtronic Sofamor Danek).
Zeh A, Planert M, Siegert G, Lattke P, Held A, Hein W.
Spine. 2007 Feb 1;32(3):348-52.
Level II – Unfavorable
Prospective cohort study. Cr/co serum levels higher in ADR than control
Level IV: 2 Studies
1. Early removal of a Maverick disc prosthesis: surgical findings and morphological changes.
François J, Coessens R, Lauweryns P.
Acta Orthop Belg. 2007 Feb;73(1):122-7.
Level IV – Unfavorable
Related Articles
2. Degenerative disorders of the lumbar spine Total disc replacement as an alternative to lumbar fusion?
Mayer HM.
Orthopade. 2005 Oct;34(10):1007-14, 1016-20. Review. German.
Level IV – Unfavorable
Review of Level IV data
LEVEL I
Randomized, controlled clinical trials. Researchers would use a computer program to randomly assign patients with back pain into two groups of 20. The first group (placebo group known as the control) would drink water (that only tasted like pomegranate juice but was not) for 10 days. The second group would drink real pomegranate juice for 10 days. None of the patients would know if they were drinking the real pomegranate juice or not. (This is called a blinded study). Then a researcher who does not know which person drank what (which now makes this a what’s called a “double blinded” study) would interview the patients to determine if their back pain was reduced, worsened or stayed the same. After this was all done, the information about which patients drank what would then be revealed. One could then see if those who drank the real pomegranate juice were better or not than the water drinking group.
LEVEL II
Non-randomized, prospective comparative study. A researcher looks at 40 patients medical records to select 20 patients for the pomegranate drinking group and 20 patients for the control group who will drink water. This is called a “cohort,” namely a control and experimental patient make a cohort. Here the researcher may introduce his own bias whether he intends to or not. If he believes pomegranate is a safe, effective treatment for back pain then whether he means to or not he may put the healthier patients with less back pain in the pomegranate group and patients complaining of more back pain in the water-drinking group. (This particular bias is called “selection bias.” See section on types of research bias.)
LEVEL III
Retrospective (already occurred) comparative study or case controlled study (each “experimental“ patient is matched to a patient that never had the experimental). This is not a reliable standard for determining one treatment over another, though it can be helpful to, say, see how many complications a certain treatment has. Researchers do a retrospective study for example reviewing 20 patient records of patients who reported they have been drinking pomegranate juice in the past and then 20 patients who have not reported drinking pomegranate juice. Then the researchers review the patients’ medical records determine if the back pain was reported better, worse or stayed the same. Here again, the selection process may introduce bias intentionally or not. In this case it may not only be selection bias, but could involve “recall” bias, or “expectation bias” or “attention bias.” (See Bias in Research section).
LEVEL IV
Case series do not determine success or failure of a treatment compared to other treatments or no treatment at all. Researchers or a physician does a case study on 20 patients who drink pomegranate juice for 10 days and then report the results. In this case there is no control group or comparison to patients who are not drinking pomegranate juice. It does not take into consideration that back pain could get better in 10 days if the patient takes nothing at all for the pain. These studies are easier and cheaper. They can be of value to determine better methods of doing a particular treatment, or what the complications of a certain treatment are, but NOT for determining if one treatment is better than another.
LEVEL V
Expert opinion. One physician expert’s opinion on if pomegranate juice helps reduce back pain. No original research is conducted. Instead, just a written opinion or editorial that may talk about other research and give opinions, but no clinical study is conducted. AME considers this to be one step above hearsay for determining one treatment over another, though it may be valuable for stimulating discussion and ideas on a particular topic.
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