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New minimally invasive lumbar interbodyfusion system shows positive outcomes

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LONDON — A new lumbar interbody fusion system was shown to improve Oswestry Disability Index and VAS pain scores when compared with a more traditional treatment, according to a presenter at the European Federation of National Associations of Orthopaedics and Traumatology Congress, here.

Robert Pflugmacher, MD, of Bonn, Germany, presented initial data from a prospective study of the Luna Interbody Spacer System (Benvenue Medical; Santa Clara, Calif.) for 11 men and 14 women with degenerative disc disease (DDD), with a mean age of 55 years.

This 54-year-old man with osteochondrosis at L2-3 underwent successful pedicle screw placement and had the expandable cage implanted, as well..

Image: Phlugmacher R

The study did not include a control group. This 54-year-old man with osteochondrosis at L2-3 underwent successful pedicle screw placement and had the expandable cage implanted, as well.

Following minimally invasive lumbar interbody fusion with the cage, patients showed positive health outcomes at 6 months, he noted.

“In the early results we did not look for fusion. We need a longer follow-up,” Pflugmacher told Spine SurgeryToday.

A new cage design

“The mini-open procedure with a new cage design allowed us to improve patients clinically, provide significant pain relief and improvement in the physical function. We had no neurological deficits. We could not see any displacement or any problems with the cage design, so it improved and showed that it was working also in the regular care,” Pflugmacher said.

The purpose of the study was to prospectively assess the clinical and radiographic outcomes of the minimal-invasive lumbar interbody fusion using the Luna Interbody Spacer System in patients with DDD at one or two contiguous levels from L1-S1.

The problem with back surgery is patients sometimes have muscle atrophy and develop degeneration of the spine, resulting in failed back surgery syndrome, according to Pflugmacher.

Therefore, minimally invasive spine surgery was developed. In 1982, the first minimal pedicle screw systems and then the minimally invasive TLIF and PLIF techniques were developed with the first minimally invasive pedicle screw developed in 2001 and published. The first minimally invasive PLIF technique was developed in about 2002 and the TLIF technique was first published in 2003, he said.

Expands to fit

The interbody spacer system features an expandable cage that can fit into a patient’s disc space and adapt to a patient’s individual anatomy, Pflugmacher said noting it can be used for mini-open and minimally invasive surgery.

In the prospective study of patients who underwent minimally invasive lumbar interbody fusion with the new system, the Luna system allowed surgeons to use a minimally invasive approach to fusion.

“You can expand the cage intraoperatively and adapt it perfectly to the intervertebral disc space height. [With] the mini-open approach — that is how we used it — you can turn the cage and expand the cage to a perfect height,” he said.

Outcomes of the study

The study included MRI and radiographs of all participants preoperatively, and radiographs were also taken at the 6-week and 6-month follow-up examinations. Preoperatively and at follow-up Pflugmacher and colleagues also evaluated patients with a neurological examination, the self-reported VAS score, Oswestry Disability Index (ODI) score and SF-36.

They placed the implant seven times at L3-4, 10 times at L4-5, and eight times at L5-S1. Between 3 mL and 10 mL of autograft bone was used, with an average use of 7.5 ml, Pflugmacher said.

At both follow-up time points, investigators observed improvements in the VAS, ODI and SF-36 scores without any implant displacement. Segmental alignment was restored, according to the study results.

“You look at the VAS scores — a significant improvement in 6 weeks and 6 months. The same with the ODI scores,” Pflugmacher said. “We saw significant pain reduction.”

The results showed 3 patients had serious adverse events, none of which were implant-related. – by Robert Linnehan