Multicenter study addresses complication rates with instrumented MIS spine surgery

VIENNA — Complication rates from minimally invasive spine surgery were found in a prospective multicenter study to be lower than investigators anticipated, with about a 1% rate of misplaced pedicle screws among 622 of these fusion and stabilizations procedures performed at five European centers from 2005 to 2010.

The study, headed by neurosurgeon Alphonse Lubansu, MD, also showed patients were not at any increased risk of a complication due to technical variables in these minimally invasive cases, which included various surgical techniques used and differing numbers of levels being fused.

Researchers also found that any pre-existing conditions these minimally invasive spine surgery (MIS) spine patients had put them at almost no greater risk of a complication than they would be after open surgery.

Centers that participated in the study were Erasmus Hospital, Brussels; Clinique Saint-Martin, Pessac, France; Hospital de São João, Porto, Portugal; Greater Manchester Neuroscience Center, Manchester, U.K.; and University of Salzburg, Salzburg, Austria.

Low-risk procedure

“Our study allows [us] to confirm in a large prospective, multicenter series that MIS spine surgery techniques used for spinal arthrodesis and interbody fusion may reduce the risk of peroperative and postoperative complications,” Lubansu, of Brussels, said at the 2010 Annual Congress of the Spine Society of Europe (EuroSpine 2010), here.

The goal of the investigation was to prospectively study the complications and their frequency among a large number of MIS spine arthrodesis procedures being performed at European centers using what is still considered a relatively new technology. Few studies to date have focused on the adverse events reported in conjunction with these fusion procedures, according to Lubansu.

The patients included were 12 to 82 years old; 417 patients underwent transforaminal lumbar interbody fusion with posterior fusion and posterior fusion alone was the next most commonly performed surgery, which was done in 110 patients. The main surgical indications included osteochondrosis, spondylolisthesis, failed back surgery syndrome and degenerative deformity, according to the abstract.

Based on evaluations performed at 3, 6, 12 and 24 postoperative months, researchers found a 2.2% rate of dural tears, a 0.7% rate of superficial and deep wound infections combined, and a 1.2% rate of misplaced screws, Lubansu said.

Early vs. late complications

In discussing these complications, he said the revision rate in the series for misplaced screws was 0.5% and although some dural tears occurred, “We have never seen any leak of cerebrospinal fluid.”

Among the complications studied, 9.2% occurred early or up to the 3-month follow-up; 3.4% of them occurred late or after 3 postoperative months, Lubansu said.

He told Orthopaedics Today Europe, “Our observations support the rationale of the MIS approach. Better respect of the muscular structure and reduced surgical trauma could be associated with a better outcome and less postoperative or late complications.” – by Susan M. Rapp

References:

• Lubansu A, Mangione P, Gnanalinghan K, et al. Complication rate after posterior minimally invasive spinal (MIS) procedures: A European multicenter prospective study. Paper #63. Presented at EuroSpine 2010. Sept. 15-17, 2010. Vienna.
• Lubansu A. Neurosurgery. 2010;56:14-22. Epub 2010 Feb.

• Alphonse Lubansu, MD, can be reached in the Neurosurgery Department, Erasmus Hospital, University Libre of Brussels, Lennik Route, 808, Brussels, 1070 Belgium; email: alubansu@ulb.ac.be.
• Disclosure: Lubansu has no relevant financial disclosures.

This information will not change my practice at present. What I heard was a collaboration between enthusiastic centers applying a new technology that is marketed heavily by the medical technology industry. What I didn’t hear was any conflict of interest statement regarding any industry support. I did note that three different methodologies were used: fixation alone, fixation with TLIF, fixation with ALIF. There was no mention of decompression, no mention of bone graft or fusion methodology and there were no clinical outcomes.

The technology was applied to over nine different pathology types ranging though tumor, fracture, stenosis and non-specific axial back pain. The early complication rate was 9.2% and the late complication rate 3.4%. I suspect there will be a greater number of late complications and re-operations when critically analyzed at 2 years. It would have been better and more useful to have concentrated on the treatment of single pathological entities, comparing just apples rather than mixing apples, oranges, pears and bananas.

The figure of incidental durotomy rates of 2.2% is a significant concern for closed procedures not involving decompression.

— Philip J. Sell, MSc, FRCS
University Hospitals of Leicester, United Kingdom
Session moderator
Disclosure: He has no relevant financial disclosures.