A single-level titanium interspinous device is associated with inferior patient outcomes when compared to laminectomy alone, a new retrospective study published in the journal Spine has shown.
The study, which was led by Aaron J. Buckland (NYU Langone Health, New York, USA and Melbourne Orthopaedic Group, Melbourne, Australia) and performed at NYU Langone Spine Research Center, New York, USA, demonstrated that the Coflex Interlaminar Stabilization device (CID) has higher perioperative 90-day complications, is associated with longer operative time and length of hospital stay, as well as higher estimated blood loss (EBL) compared to the laminectomy procedure.
The study included patients who were aged 18 and over, with lumbar stenosis and grade one stable spondylolisthesis who underwent either primary single-level decompression and implantation of CID, or single-level laminectomy alone.
A total of 83 patients were included (37 laminectomy cases and 46 single-level CID). The CID cohort was older (69±9.4 vs. 64.2±11; p=0.042) and had a higher American Society of Anesthesiologists (ASA) grade (2.59±0.73 vs. 2.17±0.48; p= 0.020).
The results of the study showed that the CID patients had higher EBL (97.50±77.76 vs. 52.84 ± 50.63mL; p=0.004), longer operative time (141.91±47.88 vs. 106.81±41.30 minutes; p=0.001), and longer length of stay (2±1.5 vs. 1.1±1.0 days, p=0.001).
Total perioperative complications (21.7% vs. 5.4%; p=0.035) and instrumentation-related complications were also higher in the CID group (10.9% vs. 0% laminectomy group; p= 0.039). There were no other significant differences between the groups in terms of demographics or outcomes.
CID is indicated for one- or two-level lumbar stenosis with grade one stable spondylolisthesis in adult patients, as an alternative to laminectomy, or laminectomy and fusion. The device aims to provide stability against progressive spondylolisthesis, retain motion, and prevent further disc space collapse.
Buckland told Spinal News International: “The use of interspinous devices remains controversial. While previous studies have concentrated on comparing this interspinous device to fusion in patients with stable spondylolisthesis and lumbar stenosis, there is controversy as to whether decompression alone is also a valid alternative.
“Our study demonstrates that there is no demonstrated advantage to the interspinous device over decompression alone, but a higher perioperative complication rate.
“The authors acknowledge the limitations inherent to retrospective and single-centre studies, and believe that further prospective studies to compare decompression alone to interspinous device are necessary to demonstrate clinical advantage of interspinous devices to justify the increase in cost.”
A conclusion that has been long awaited! For forty years I have undertaken simple laminectomies and lateral recess decompressions for this group of patients and have had excellent results with minimal complications. These patients have stiff spines and are often elderly and not placing high level physical demand on their spines. Back pain is rare in this group too because they often have developed severe stenosis and the segment has to remain “stiff'”, especially the disc, as they would otherwise be incredibly symptomatic or nearly paralysed!.The logic for fusions and these devices deserves thorough challenge and this result is what many experienced oder surgeons knew was inevitable.