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Spinal Kinetics M6 Disc Replacement - No revisions

"The kinematic signatures of the intact human disc and the M6 artificial disc are nearly identical."
"There has been no serious device-related adverse events, surgical re-interventions, or evidence of device migration, expulsion, or subsidence in this study group." More about M6 disc replacement here > >


ProDisc Lumbar Disc Replacement - "requiring revision surgery at the index level in 8.7% of the patients"

ProDisc-L Study

Clinical Results of Total Lumbar Disc Replacement With ProDisc:
Three-Year Results for Different Indications.

Spine. 31(17):1923-1932, August 1, 2006.
Siepe, Christoph J. MD; Mayer, H Michael MD, PhD; Wiechert, Karsten MD; Korge, Andreas MD
Abstract: Prospective study analyzing midterm clinical results of total lumbar disc replacement (ProDisc II) for different indications.
The overall complication rate was 19.6%, requiring revision surgery at the index level in 8.7% of the patients and another 2.2% at the non-index level following TDR. There were no vertebral body fractures as reported previously by other authors. Furthermore, there were no direct vessel lacerations in any of the patients. Complication rate was considerably higher for bisegmental disc replacements (n = 5 of 14 operations; 35.7%) compared with monosegmental interventions (n = 11 of 77; 14.3%).
Full Study > >

The Center of Rotation (COR) of the Prodisc doubles the natural arc at the facets!
Furthermore, the Prodisc translates A/P 1mm for every 3 of rotation. Thus, for a total possible 20, we see 6.6mm shear added to the already double arc. A natural disc has 15 AP arc. As well, the Prodisc allows 20 lateral rotation, compared to 10 natural. And, the Prodisc is totally unconstrained in 360 Axial rotation, compared to 6 in natural discs! ALL forces are only restricted by the Facet joints!.

Warning! - Long term facet arthrosis due to hyper-mobility.
Early Ball in Socket implants like Pro Disc inherently increase freedom of movement without restraint. The fundamental function of the facets is to limit motion. It has been found that the hyper-mobility of these implants will initiate or exacerbate the progression of facet Arthrosis and back pain.
Read the study details here.
Choose your implant carefully!

A GRAVE ERROR IN TREATMENT
Two years later, through a German investigation, an independent 'MDK' medical doctor presented to us a report stating that the surgery that occurred in Straubing with Dr. Bertagnoli was a Grave Error on multiple factors and "for completely incomprehensible, medically not understandable reasons, it has been contravened grossly against the indication criteria for implantation of spinal disk protheses"


Charite - "There were 10 patients (4.9%) in the Charite group[revision required]".


The FDA Trial results, DEPARTMENT OF HEALTH AND HUMAN SERVICES
The subject of this review is P040006, the clinical module for M020026/M003, dated 2/13/04 and received 2/13/04.
The subject device is the Charite Artificial Disc, consisting of two CoCrMo alloy endplates and an UHMWPE core, indicated for spinal arthroplasty in patients with single-level lumbar degenerative disc disease (DDD) from L4 to S1. The sponsor conducted a non-inferiority randomized, prospective clinical trial comparing the clinical results of treatment with the subject device and anterior interbody fusion using the BAK fusion cage. The study demonstrated that the Charite Artificial Disc is safe and effective in the treatment of lumbar DDD compared to anterior interbody fusion with the BAK cage.

Device Failures:
Device failures were defined as a reoperation, revision, removal, or supplemental fixation of the device. There were 10 patients (4.9%) in the Charite group and 8 patients (8.1%) in the BAK group with device failures.
Full Study > >

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Revised: 02/20/10