The Memory Metal Spinal System in a Posterior Lumbar Interbody Fusion (PLIF) Procedure: A Prospective, Non-Comparative Study to Evaluate the Safety and Performance.

By London Spine
Related Articles

The Memory Metal Spinal System in a Posterior Lumbar Interbody Fusion (PLIF) Procedure: A Prospective, Non-Comparative Study to Evaluate the Safety and Performance.

Open Orthop J. 2012;6:220-5

Authors: Kok D, Grevitt M, Wapstra F, Veldhuizen A

Abstract
STUDY DESIGN: A prospective, non-comparative study of 27 patients to evaluate the safety and performance of the Memory Metal Spinal System used in a PLIF procedure in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease (DDD).
OBJECTIVE: To evaluate the clinical performance, radiological outcome and safety of the Memory Metal Spinal System, used in a PLIF procedure, in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease in human subjects.
SUMMARY OF BACKGROUND DATA: Spinal systems that are currently available for correction of spinal deformities or degeneration such as lumbar spondylosis or degenerative disc disease, use components manufactured from stainless steel or titanium and typically comprise two spinal rods with associated connection devices. The Memory Metal Spinal System consists of a single square spinal rod made from a nickel titanium alloy (Nitinol) used in conjunction with connection devices. Nitinol is characterized by its shape memory effect and is a more flexible material than either stainless steel or titanium. With current systems there is loss of achieved reposition due to the elastic properties of the spine. By using a memory metal in this new system the expectation was that this loss of reposition would be overcome due to the metal’s inherent shape memory properties. Furthermore, we expect a higher fusion rate because of the elastic properties of the memory metal.
METHODS: Twenty-seven subjects with primary diagnosis of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease (DDD) were treated with the Memory Metal Spinal System in conjunction with the Brantigan IF® Cage in two consecutive years. Clinical performance of the device was evaluated over 2 years using the Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36) and pain visual analogue scale (VAS) scores. Safety was studied by collection of adverse events intra-operative and during the followup. Interbody fusion status was assessed using radiographs and a CT scan.
RESULTS: The mean pre-operative ODI score of 40.9 (±14.52) significantly improved to 17.7 (±16.76) at 24 months postoperative. Significant improvement in the physical component from the SF36 questionnaire was observed with increases from the baseline result of 42.4 to 72.7 at 24 months (p<.0001); The emotional component in the SF36 questionnaires mean scores highlighted a borderline significant increase from 56.5 to 81.7 at 24 months (p=0.0441). The average level of leg pain was reduced by more than 50% postoperation (VAS values reduced from 5.7 (±2.45) to 2.2 (±2.76) at 24 month post-operation with similar results observed for back pain. CT indicated interbody fusion rate was not significantly faster compared to other devices in literature. No device related adverse events were recorded in this study.
CONCLUSIONS: The Memory Metal Spinal System, different from other devices on the market with regard to material and the one rod configuration, is safe and performed very well by improving clinically important outcomes in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease. In addition the data compares favorably to that previously reported for other devices in the literature.

PMID: 22754599 [PubMed]

Metal ion levels in patients with a lumbar metal-on-metal total disc replacement: should we be concerned?

By London Spine
Related Articles

Metal ion levels in patients with a lumbar metal-on-metal total disc replacement: should we be concerned?

J Bone Joint Surg Br. 2011 Jul;93(7):949-54

Authors: Bisseling P, Zeilstra DJ, Hol AM, van Susante JL

Abstract
The purpose of this study was to evaluate whether concerns about the release of metal ions in metal-on-metal total hip replacements (THR) should be extended to patients with metal-bearing total disc replacements (TDR). Cobalt and chromium levels in whole blood and serum were measured in ten patients with a single-level TDR after a mean follow-up of 34.5 months (13 to 61) using inductively-coupled plasma mass spectrometry. These metal ion levels were compared with pre-operative control levels in 81 patients and with metal ion levels 12 months after metal-on-metal THR (n = 21) and resurfacing hip replacement (n = 36). Flexion-extension radiographs were used to verify movement of the TDR. Cobalt levels in whole blood and serum were significantly lower in the TDR group than in either the THR (p = 0.007) or the resurfacing group (p < 0.001). Both chromium levels were also significantly lower after TDR versus hip resurfacing (p < 0.001), whereas compared with THR this difference was only significant for serum levels (p = 0.008). All metal ion levels in the THR and resurfacing groups were significantly higher than in the control group (p < 0.001). In the TDR group only cobalt in whole blood appeared to be significantly higher (p < 0.001). The median range of movement of the TDR was 15.5° (10° to 22°). These results suggest that there is minimal cause for concern about high metal ion concentrations after TDR, as the levels appear to be only moderately elevated. However, spinal surgeons using a metal-on-metal TDR should still be aware of concerns expressed in the hip replacement literature about toxicity from elevated metal ion levels, and inform their patients appropriately.

PMID: 21705569 [PubMed – indexed for MEDLINE]

Prospective study on serum metal levels in patients with metal-on-metal lumbar disc arthroplasty.

By London Spine
Related Articles

Prospective study on serum metal levels in patients with metal-on-metal lumbar disc arthroplasty.

Eur Spine J. 2012 Nov 20;

Authors: Gornet MF, Burkus JK, Harper ML, Chan FW, Skipor AK, Jacobs JJ

Abstract
PURPOSE: Metal-on-metal total disc replacement is a recent alternative treatment for degenerative disc disease. Wear and corrosion of these implants can lead to local and systemic transport of metal debris. This prospective longitudinal study examined the serum chromium and cobalt levels in 24 patients with cobalt-chromium alloy metal-on-metal lumbar disc replacements. METHODS: Serum was assayed for chromium (Cr) and cobalt (Co) using high-resolution inductively-coupled plasma-mass spectrometry. Detection limits were 0.015 ng/mL for Cr and 0.04 ng/mL for Co. RESULTS: Median serum Co levels at pre-op, 3, 6, 12, 24, and 36-months post-op were 0.10, 1.03, 0.96, 0.98, 0.67, and 0.52 ng/mL, respectively. Median serum Cr levels were 0.06, 0.49, 0.65, 0.43, 0.52, and 0.50 ng/mL, respectively. CONCLUSION: In general, these results indicated that serum Co and Cr levels are elevated at all postoperative time points and are of the same order of magnitude as those observed in well-functioning metal-on-metal surface replacements of the hip and in metal-on-metal total hip replacements at similar postoperative time points.

PMID: 23179981 [PubMed – as supplied by publisher]