Addition of a Plasma-Sprayed Titanium Coated PEEK Interbody Implant to Anterior Lumbar Interbody Fusion Shows High Success Rate

Lead author Joseph Sclafani, MD, and SpineUniverse Editorial Board member Khoi D. Than, MD, comment

Peer Reviewed

Addition of a plasma-sprayed titanium coating (PTC) to polyether ether ketone (PEEK) spacers was linked to rapid and stable fixation at the bone-implant interface in patients undergoing anterior lumbar interbody fusion (ALIF) in a retrospective, nonrandomized study. The procedure was associated with significant improvements in pain outcomes, low implant subsidence, and a high definitive rate of arthrodesis, as reported in the January issue of the International Journal of Spine Surgery.

surgeon views a lumbar x-ray“Ninety-six percent of subjects demonstrated early complete radiographic fusion and there were zero cases of subsidence or implant migration” The study involved 44 patients (48% male, mean age, 53 years) who received a PTC PEEK implant during single or multi-level ALIF procedure. The devices used in this study were Magnum+ PEEK implants containing Spinal Element’s proprietary Ti-Bond porous titanium coating.

“There was both statistical and clinically significant improvement in low back and radiating leg pain across all analyzed patient subgroups at the 9-month post-operative time point,” explained lead author Joseph Sclafani, MD, physician at the Spine Institute of San Diego, Minimally Invasive Spine Centers of Excellence, San Diego, CA. Specifically, VAS low back pain score improved by 4.5 ± 2.4 points and VAS leg pain score improved by 4.1 ± 3.3 points.

“Ninety-six percent of subjects demonstrated early complete radiographic fusion (on average at 7.3 months) and there were zero cases of subsidence or implant migration,” Dr. Sclafani told SpineUniverse. “Quite importantly, subgroups that are known to be at high risk for an incomplete fusion (tobacco users, advanced age, metabolic comorbidities) demonstrated excellent clinical and radiographic outcomes when a plasma-sprayed titanium coated PEEK interbody implant was utilized in an ALIF procedure.”

Study Limitations
“The main limitation of our study was that it was conducted at a single site, which is a Minimally Invasive Spine Center of Excellence located in a relatively affluent region,” Dr. Sclafani said. “There would be great implications to overall generalizability if a follow-up study reported multisite outcomes with arthrodesis confirmation uniformly by CT imaging. Discussions about study design and site locations for such a study are currently underway.”

“Surface technology is all the rage right now, and the authors report an excellent fusion rate that is similar to that found in studies of other surface technologies,” commented Khoi D. Than, MD, Assistant Professor in the Department of Neurological Surgery at Oregon Health and Science University in Portland, Oregon.

“My own clinical bias is that I believe success is mostly dependent on how the surgery is performed, such as making sure that the disc space and endplates are prepared well and placing the appropriate milieu in the cage for bony growth to occur,” said. Dr. Than, who is a member of the SpineUniverse Editorial Board. “If you don’t place the appropriate bone growth factors, it is not going to heal.”

Dr. Than concluded that introducing randomization to future studies of this technology is of value, and will help determine whether this technology is better than other technologies on the market.

Disclosures
The study authors were consultants or employees of MileStone Research Organization, a third party clinical research company contracted by Spinal Elements to assist with the research. Neither the authors nor MileStone Research had any financial ties, direct or indirect, to outcomes or data presented in the study.

Dr. Than has no relevant disclosures.

Updated on: 03/20/18
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Higher Than Expected Rate of Reoperation Found Following Final Fusion in Early-Onset Scoliosis
Khoi D. Than, MD
Assistant Professor
Department of Neurological Surgery
Oregon Health & Science University
Portland, OR
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