Decompression and Coflex Interlaminar Stabilization Compared With Decompression and Instrumented Spinal Fusion for Spinal Stenosis and Low-Grade Degenerative Spondylolisthesis

Abstract

1.

Clinical analysis following lumbar interspinous devices implant: where we are and where we go

“…[13][14][15][16][17] Results from randomized, multicenter trials clearly demonstrate that the interspinous device improves clinical symptoms and function significantly compared with epidural steroid injections and conservative therapy in patients with symptoms of neurogenic intermittent claudication. 18,19 Our findings are in agreement with these data and further provide the opportunity to compare patients with LDH in whom the interspinous system has been inserted following microdiscectomy with a control group.…”

Minimally invasive surgery for lumbar spinal stenosis

“…However, most of these studies did not compare the results with other interventions, and most did not have prospective study designs [17]. It took 30 years (from 1984 until 2013) until two prospective studies were published that compared IPD treatment with conventional (surgical) care [5,18,19]. These studies showed that treatment with IPD was not superior compared to bony decompression without implants and that IPD treatment resulted in a higher reoperation rate.…”

Therapeutic Sustainability and Durability of Coflex® Interlaminar Stabilization after Decompression for Lumbar Spinal Stenosis: A Four-Year Assessment

“…To determine TSE, additional factors analyzed and combined with CCS included index-level motion preservation in the ILS group, decrease in index-level motion in the fusion group, unaltered kinematics at the adjacent level for either group, and maintenance of foraminal height in the ILS group. detail, 7,8 only a brief summary follows: randomization was 2:1, resulting in 230 and 114 patients receiving ILS and fusion during the enrollment period from 2006 through 2010 at 21 participating US sites. Main inclusion criteria were: radiographic confirmation of moderate to severe stenosis, age range from 40-80; ODI score ≥ 40 (out of 100), VAS for back pain of ≥ 50mm (out of 100mm), failing ≥ 6 months of conservative care including ≥ 1 epidural steroid injection, no prior decompression surgery, up to a Grade 1 stable spondylolisthesis, and a willingness to consent to participation.…”

“…7 The device is approved for use in patients with one-or two-level lumbar stenosis and up to a Grade 1 spondylolisthesis. 8 It was examined under an investigational device exemption (IDE) beginning in 2006, and approved under premarket approval (PMA) in the USA in October, 2012.…”

“…7 coflex is a U-shaped titanium device which is implanted deep within the inter-laminar space, providing neutral stabilization while maintaining normal spinal kinematics. The device allows for compression in extension while permitting normal flexion.…”