Evaluation of AxiaLIF - 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

EVALUATION OF AxiaLIF - Trans 1

AxiaLIF

AME STAR RATING:
GOOD Predictive Value for success of procedure

METHOD: PubMed was searched for all English language literature on the procedure and Therapeutic Procedure analyses only were chosen.

TOTAL: 7 PERCUTANEOUS LUMBO STUDIES
Studies FAVORABLE Click Here to see studies	Seven Studies	2 Level II 1 Level III 3 Level IV 1 Level V

Preponderance of evidence is favorable and > 25% are Level II

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

REFERENCES

AxiaLIF
Studies Favorable: Total 7

Level II: 2 Studies

1. Ledet E, Tymeson M, Salerno S, Carl A, Cragg A: Biomechanical Evaluation of
a Novel Lumbosacral Axial Fixation Device, Journal of Biomechanical
Engineering, November 2005, Volume 127, Issue 6, pp. 929-933
A comparison biomechanically with similar interbody fixation devices.
Concludes comparable biomechanical fixation in prospective cohorts
Level II - Favorable

2. Aryan H, Newman C, Acosta F, Coover C, Ames C. Percutaneous Axial
Lumbar Interbody Fusion (AxiaLIF) of the L5-S1 Segment: Initial Clinical
and Radiographic Experience. J Spinal Disord Tech, Accepted for Publication,
not yet published. (35 patient series, 24 months, prospective, non-randomized)
Level II - Favorable

Level III: 1 Study

1. Shen, F; Samartzis, D; Khanna, A; Anderson, DA. Minimally Invasive
Techniques for Lumbar Interbody Fusions. Orthop Clin N Am 38 (2007) 373–386.
Systematic review of 3 Star studies –
Level III - Favorable

Level IV: 3 Studies

1. Khoo L, Marotta N, Cosar M, Pimenta L : Novel Minimally-Invasive Presacral
Approach and Instrumentation Technique for Anterior L5-S1 Intervertebral
Discectomy and Fusion: Technical Description and Case Presentations, J
Neurosurgery and American Association of Neurological Surgeons:
Neurosurgical Focus, Volume 20, January, 2006
Level IV - Favorable

2. Akeson B, Wu C, Mehbod A, Transfeldt E: Biomechanical Evaluation of
Anterior Transacral Fixation, J Spinal Disord Tech. 21(1):39-44, February 2008.
Cadaver case series for biomechanical evaluation is favorable
Level IV - Favorable

3. Asgarzadie, F; Khoo LT; Cosar, M; Marotta, N; Pimenta, L. One Year
Outcomes of Minimally-Invasive Presacral Approach and Instrumentation
Technique for Anterior Lumbosacral Intervertebral Discectomy and Fusion.
Proceedings of the 22nd Annual Meeting, The Spine Journal, Volume 7, Number
55, Sept/Oct 2007, Special Interest Paper Presentations 4: Fusion, 26-27S. 6/4/2008
Case series of 16 patients at one year f\u 92% fusion
Level IV - Favorable

Level V: 1 Study

1. Ledet EH, Carl AL, Cragg A. Novel Lumbosacral Axial Fixation Techniques.
Expert Review of Medical Devices, 2006; 3(3); 327-34.
Level V - Favorable