Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis

Abstract

CCS, composite clinical successCEC, clinical events committeeFDA, Food and Drug AdministrationIDE, investigational device exemptionILS, Coflex Interlaminar StabilizationODI, Oswestry Disability IndexSF-12, Short-Form 12VAS, visual analogue scalesZCQ, Zurich Claudication Questionnaire.

Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis? A Seven-Year Follow-up

“…However, Coflex group had the advantages of less trauma, less intraoperative blood loss, early ambulation and shorter hospitalization days compared with fusion group. The results of the present study were consistent with those of previous researches [21][22][23][36][37][38][39].…”

“…Since then, the device has been used in various degenerative spinal conditions [21][22][23][24][36][37][38]. Although it was initially developed as a motion-preserving alternative used to treat various lumbar degenerative disorders, long-term studies from Europe suggested that the subset of patients with spinal stenosis and Grade I spondylolisthesis experienced the most significant improvement.…”

“…In order to overcome these deficiencies associated with fusion surgery, an interspinous process device-Coflex system (Paradigm Spine, LLC, New York) was developed as a possible alternative to spinal decompression with posterolateral fusion and instrumentation [18][19][20]. Although the encouraging results of Coflex have been widely reported in the past a few years [21][22][23][24], there is still controversy of the long-term benefit of this procedure. High complication such as prosthesis loosening and spinous process fracture, reoperation rate, and costs with poor outcomes were also mentioned in the literature [25][26][27].…”

A novel strategy of non-fusion instrumentation with coflex interlaminar stabilization after decompression for lumbar spinal stenosis

“…As mentioned above, the ability of the ILS to provide relief of painful symptoms while maintaining segmental motion at both operated and adjacent levels is remarkable (7). In addition, the ILS maintains segmental stabilization without increasing angular and translational motion at the adjacent segments, thus maintaining the kinematics of the adjacent level.…”

“…The ILS study reported by Bae et al (7) targeted patients with degenerative spondylolisthesis up to Meyerding grade I who were evaluated in sagittal plane translation on flexion-extension radiographs; however, they did not evaluate the scoliotic degeneration in the coronal plane. Considering that the mean change from preoperative to month 36 was only −0.30 mm in foraminal height after the ILS implant, the ILS might be also useful for the treatment © OSS Press Ltd. All rights reserved.…”