History of Evidence Based Medicine - Association For Medical Ethics

Predictive Value
for Success

EXCELLENT
> 25% of all studies are Level I

GOOD
> 25% of all studies are Level II or better

FAIR
> 25% of all studies are Level III or better

POOR
> 25% of all studies are Level IV or better

VERY POOR
< 25% of all studies are Level IV or better

Evidence Based
Medicine
Level Rating System

LEVEL I
Randomized, controlled clinical trials - This is the most objective and valid study results. This study has posted the highest level of quality for evidence based medicine.

LEVEL II
Prospective non-randomized, comparative studies - This is the second most objective and valid study results.

LEVEL III
Retrospective comparative or case controlled studies - These studies look back historically and compare them with other cases in the past. The problem with this system is that these past patients may not have been chosen or treated - or not treated at all - on equal standings.

LEVEL IV
Case Series - This where a group of patients have a particular treatment, and then observations are made about them. This does not differentiate between the success or failure of the treatment compared to other treatments or no treatment at all. For example treating back pain for 10 days by drinking pomegranate juice may show all patients got better and conclude this should be the treatment for back pain. However, usually all back pain gets better in 10 days no matter what one does.

LEVEL V
Expert opinion. This is a person's opinion only. It's an editorial, and is considered the lowest level of evidence to support a position. AME considers this to be Comparable to hearsay.

For More Information
On Evidence Based Medicine
Rating System Click Here

AME Star Rating System

LUMBAR DISC REPLACEMENTS

CHARITE

AME STAR RATING:
POOR Predictive Value for success of procedure

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
Studies FAVORABLE Click Here to see studies	14 Studies	2 Level I 12 Level IV
Studies UNFAVORABLE Click Here to see studies	4 Studies	1 Level I 3 Level IV
Studies NEUTRAL Click Here to see studies	2 Studies	2 Level IV

>25% of studies (85%) are Level IV

Click Here for description of Evidence Based Medicine Click Here for description of AME Rating System

PRODISC

AME STAR RATING:
POOR Predictive Value for success of procedure

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: 13 Prodisc Studies
Studies FAVORABLE Click Here to see studies	12 Studies	12 Level IV
Studies UNFAVORABLE Click Here to see studies	1 Studies	1 Level IV

>25% of studies (92%) are Level IV

Click Here for description of Evidence Based Medicine Click Here for description of AME Rating System

MAVERICK

AME STAR RATING:
VERY POOR Predictive Value for success of procedure

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 Study
Studies FAVORABLE Click Here to see studies	7 Studies	6 Level IV 1 Level IV
Studies UNFAVORABLE Click Here to see studies	3 Studies	1 Level II 2 Level IV

>25% of favorable studies are Level IV which is the preponderance of data

Click Here for description of Evidence Based Medicine Click Here for description of AME Rating System

REFERENCES

CHARITE:
Studies Favorable: Total 14

Level I: 2 Studies

1. McAfee PC, Cunningham B, Holsapple G, Adams K, et al. 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. Spine 2005;30:1576-83.
Level I - Favorable

2. Blumenthal S, McAfee PC, Guyer RD, et al. 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. Spine 2005;30:1565-75
Level I - Favorable

Level IV: 12 Studies

1. Huang RC, Lim MR, Girardi FP, Cammisa FP Jr. The prevalence of contraindications to total disc replacement in a cohort of lumbar surgical patients. Spine 2004;29:2538-41. http://journals.lww.com/spinejournal/Fulltext/2004/11150/The_Prevalence_of_Contraindications_to
_Total_Disc.14.aspx
Level IV - Favorable
Case series with historical control.

2. David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITÉ artificial disc in 106 patients. Spine 2007;32:661-6.
Level IV - Favorable

3. Patel VV, Andrews C, Pradhan BB, et al. Computed tomography assessment of the accuracy of in vivo placement of artificial discs in the lumbar spine including radiographic and clinical consequences. Spine 2006;31:948-53
Level IV - Favorable
Prospective case series without control

4. Lemaire JP, Carrier H, Ali el-HS, et al. Clinical and radiological outcomes with the Charité trade mark artificial disc: a 10-year minimum follow-up. J Spinal Disord Tech 2005;18:353-9.
Level IV - Favorable

5. Huang RC, Tropiano P, Marnay T, et al. Range of motion and adjacent level degeneration after lumbar total disc replacement. Spine J 2006;6:242-7.
Level IV - Favorable

6. Trouillier H, Kern P, Refior HJ, Muller-Gerbl M. A prospective morphological study of facet joint integrity following intervertebral disc replacement with the CHARITÉ Artificial Disc. Eur Spine J 2006;15:174-82.
Level IV - Favorable

7. 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;8:210-7.
Level IV - Favorable

8. Regan JJ. Clinical results of Charité lumbar total disc replacement. Orthop Clin North Am 2005;36:323-40
Level IV - Favorable

9. Sott AH, Harrison DJ. Increasing age does not affect good outcome after lumbar disc replacement. Int Orthop 2000;24:50-3
Level IV - Favorable

10. Tortolani PJ, Cunningham BW, Eng M, et al. 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;89:82
Level IV - Favorable
Case series observing incidence of Heterotopic ossification

11. Mayer HM, Wiechert K, Korge A, Qose I. Minimally invasive total disc replacement: surgical technique and preliminary clinical results. Eur Spine J 2002;11(Suppl 2):S124-30
Level IV - Favorable

12. Lemaire JP, Skalli W, Lavaste F, et al. Intervertebral disc prosthesis. Results and prospects for the year 2000. Clin Orthop Relat Res 1997;337:64-76
Level IV - Favorable

CHARITE:
Studies Unfavorable: Total 4

Level I: 1 Study

1. Mirza SK. Point of view: commentary on the research reports that led to food and drug administration approval of an artificial disc. Spine 2005;30:1561-4
Level I - Unfavorable
Systematic review of Level I studies

Level IV: 3 Studies

1. Spine:Volume 33(11)15 May 2008pp 1262-1269
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‡
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. Shim CS, Lee SH, Shin HD, et al. Charité versus ProDisc: a comparative study of a minimum 3-year follow-up. Spine 2007;32:1012-8.
Level IV - Unfavorable

3. 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;16:369-83.
Level IV - Unfavorable

CHARITE:
Studies Neutral: Total 2

Level IV: 2 Studies

1. Cinotti G, David T, Postacchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine 1996;21:995-1000.
Level IV - Neutral

2. Huang RC, Girardi FP, Cammisa FP Jr, et al. Correlation between range of motion and outcome after lumbar total disc replacement: 8.6-year follow-up. Spine 2005;30:1407-11
Level IV - Neutral

PRODISC:
Studies Favorable: Total 12

Level IV: 12 Studies

1. Zigler J, Delamarter R, Spivak JM, 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 2007;32:1155-63.
Level IV - Favorable

2. Siepe CJ, Mayer HM, Heinz-Leisenheimer M, Korge A. Total lumbar disc replacement: different results for different levels. Spine 2007;32:782-90.
Level IV - Favorable

3. Siepe CJ, Mayer HM, Wiechert K, Korge A. Clinical results of total lumbar disc replacement with ProDisc II: three-year results for different indications. Spine 2006;31:1923-32
Level IV - Favorable

4. Bertagnoli R, Yue JJ, Shah RV, et al. 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. Spine 2005;30:2230-6
Level IV - Favorable

5. Bertagnoli R, Yue JJ, Shah RV, et al. 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. Spine 2005;30:2192-9.
Level IV - Favorable

6 Chung SS, Lee CS, Kang CS. Lumbar total disc replacement using ProDisc II: a prospective study with a 2-year minimum follow-up. J Spinal Disord Tech 2006;19:411-5
Level IV - Favorable

7. Tropiano P, Huang RC, Girardi FP, Marnay T. Lumbar disc replacement: preliminary results with ProDisc II after a minimum follow-up period of 1 year. J Spinal Disord Tech 2003;16:362-8
Level IV - Favorable

8. Putzier M, Funk JF, Schneider SV, Gross C, et al. Charité total disc replacement-clinical and radiographical results after an average follow-up of 17 years. Eur Spine J 2006;15:183-95
Level IV - Favorable

9. Bertagnoli R, Yue JJ, Nanieva R, et al. 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. J Neurosurg Spine 2006;4:85-90.
Level IV - Favorable

10. Bertagnoli R, Kumar S. Indications for full prosthetic disc arthroplasty: a correlation of clinical outcome against a variety of indications. Eur Spine J 2002;11(Suppl 2):S131-6.
Level IV - Favorable

11. Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up. J Bone Joint Surg Am 2005;87:490-6.
Level IV - Favorable

12. Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up. J Bone Joint Surg Am 2005;87:490-6.
Level IV - Favorable

PRODISC:
Studies Unfavorable: Total 1

Level IV: 1 Study

1.Shim CS, Lee SH, Shin HD, et al. Charité versus ProDisc: a comparative study of a minimum 3-year follow-up. 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
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