EVALUATION OF AxiaLIF –
METHOD: PubMed was searched for all English language literature on the procedure and Therapeutic Procedure analyses only were chosen.
TOTAL: 7 AxiaLIF STUDIES
2 Level II
1 Level III
3 Level IV
1 Level V
Studies Favorable: Total 7
Level II: 2 Studies
1. Biomechanical Evaluation of a Novel Lumbosacral Axial Fixation Device
Ledet E, Tymeson M, Salerno S, Carl A, Cragg A
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. Percutaneous Axial Lumbar Interbody Fusion (AxiaLIF) of the L5-S1 Segment: Initial Clinical and Radiographic Experience.
Aryan H, Newman C, Acosta F, Coover C, Ames C.
Minim Invasive Neurosurg
(35 patient series, 24 months, prospective, non-randomized)
Level II – Favorable
Level III: 1 Study
1. Minimally InvasiveTechniques for Lumbar Interbody Fusions
Shen, F; Samartzis, D; Khanna, A; Anderson, DA.
Orthop Clin N Am 38 (2007) 373–386.
Systematic review of 3 Star studies
Level III – Favorable
Level IV: 3 Studies
1. Novel Minimally-Invasive Presacral Approach and Instrumentation Technique for Anterior L5-S1 Intervertebral Discectomy and Fusion: Technical Description and Case Presentations
Khoo L, Marotta N, Cosar M, Pimenta L.
J Neurosurgery and American Association of Neurological Surgeons:
Neurosurgical Focus, Volume 20, January, 2006
Level IV – Favorable
2. Biomechanical Evaluation of Anterior Transacral Fixation
Akeson B, Wu C, Mehbod A, Transfeldt E.
J Spinal Disord Tech. 21(1):39-44, February 2008.
Cadaver case series for biomechanical evaluation is favorable
Level IV – Favorable
3. One Year Outcomes of Minimally-Invasive Presacral Approach and Instrumentation Technique for Anterior Lumbosacral Intervertebral Discectomy and Fusion.
Asgarzadie, F; Khoo LT; Cosar, M; Marotta, N; Pimenta, L.
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. Novel Lumbosacral Axial Fixation Techniques
Ledet EH, Carl AL, Cragg A.
Expert Review of Medical Devices, 2006; 3(3); 327-34.
Level V – Favorable
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.
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.)
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).
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.
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.