DYNESYS - DYNAMIC STABILIZATION

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

DYNESYS - DYNAMIC STABILIZATION

DYNESYS

AME STAR RATING:
POOR Predictive Value for success of procedure

METHOD: Peer reviewed English language publications of Therapeutic Studies only - investigating the results of treatment - for Dynesys dynamic stabilization system specifically were evaluated.

TOTAL: 9 DYNESYS STUDIES
Studies FAVORABLE: Click Here to see studies	Three Studies	3 Level IV
Studies UNFAVORABLE: Click Here to see studies	Three Studies	3 Level IV
Studies NEUTRAL: Click Here to see studies	Three Studies	3 Level IV
Favorable, neutral, and unfavorable studies were equal in number and Evidence Based Medicine strength with all being Level IV ratings.

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

REFERENCES

DYNESYS
Studies Favorable: Total 3

Level IV: 3 Studies

1. The Surgical Treatment of the Lumbar Disc Prolapse: Nucleotomy With Additional Transpedicular Dynamic Stabilization Versus Nucleotomy Alone.
Clinical Case Series
Spine. 30(5):E109-E114, March 1, 2005.
Putzier, Michael MD; Schneider, Sascha V. MD; Funk, Julia F. MD; Tohtz, Stephan W. MD; Perka, Carsten PhD
Case series. Less degeneration after discectomy with Dynesys.
Level IV - Favorable

2. Stabilization of the Lumbar Spine Using the Dynamic Neutralization System
By George S. Sapkas, MD; George S. Themistocleous, MD; Andreas F. Mavrogenis, MD; Ioannis S. Benetos, MD; Nikolaos Metaxas, MD; Panayiotis J. Papagelopoulos, MD, DSc
ORTHOPEDICS 2007; 30:859
Retrospective case series. Results comparable to fusion. Felt to be safe and effective.
Level IV - Favorable

3. The dynamic neutralization system for the spine: a multi-center study of a novel non-fusion system
Thomas M. Stoll, Gilles Dubois and Othmar Schwarzenbach Eur Spine J. Oct 2002; 11 Suppl 2: S170-178
Case series. Results comparable to fusion. Felt to be safe and effective.
Level IV - Favorable

DYNESYS
Studies Unfavorable: Total 3

Level IV: 3 Studies

1. Spine:Volume 30(3)1 February 2005pp 324-331
Clinical Experience With the Dynesys Semirigid Fixation System for the Lumbar Spine: Surgical and Patient-Oriented Outcome in 50 Cases After an Average of 2 Years
[Clinical Case Series]
Grob, Dieter MD*; Benini, Arnoldo MD*; Junge, Astrid PhD*; Mannion, Anne F. PhD*†
Retrospective case series of 50 patients. At 2 years, 50% patient dissatisfaction. Reoperation rate high.
Level IV - Unfavorable

2. Dynamic Neutralization of the Lumbar Spine After Microsurgical Decompression in Acquired Lumbar Spinal Stenosis and Segmental Instability.
Clinical Case Series
Spine. 33(3):E66-E72, February 1, 2008.
Wurgler-Hauri, Carola C. MD; Kalbarczyk, Andreas MD; Wiesli, Markus MD; Landolt, Hans MD; Fandino, Javier MD
Case series with 20% reoperation at 1 year. Results better than nothing or other stabilization systems.
Level IV - Unfavorable

3. Dynamic Stabilization in the Surgical Management of Painful Lumbar Spinal Disorders.
Focus Paper
Spine. Painful Motion Segment. 30(16S) Supplement:S68-S72, August 15, 2005.
Nockels, Russ P. MD
Literature review, including Dynesys, of case series or AME two** star studies. Guarded results that may help with future developments and randomized controlled studies need to be done.
Level IV - Unfavorable

DYNESYS
Studies Neutral: Total 3

Level IV: 3 Studies

1. Minimum Four-Year Follow-up of Spinal Stenosis With Degenerative Spondylolisthesis Treated With Decompression and Dynamic Stabilization.
Clinical Case Series
Spine. 33(18):E636-E642, August 15, 2008.
Schaeren, Stefan MD *; Broger, Ivan MD +; Jeanneret, Bernhard MD *
Case series with degeneration continuing, though satisfied patients.
Level IV - Neutral

2. The Dynesys Lumbar Spinal Stabilization System: A Preliminary Report on Positional Magnetic Resonance Imaging Findings.
Diagnostics
Spine. 32(6):685-690, March 15, 2007.
Beastall, James MRCS *; Karadimas, Efthimios *; Siddiqui, Manal FRCS *; Nicol, Malcolm MRCS *; Hughes, Justin MRCS +; Smith, Francis FRCR *; Wardlaw, Douglas FRCS *
Case series of 24 patients. At 9 mos. F/U MRI showed decrease in motion at index level and decrease anterior disc ht. Level IV - Neutral

3. Point of View: Dynamic Stabilization in Addition to Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis
Spine:Volume 31(4)15 February 2006p 450
[Clinical Case Series: Point of View]
Sengupta, Dilip K. MD
Case series. Clinical improvement. Question of long term viability. Complications present.
Level IV - Neutral