Role of Coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis

Abstract

Study DesignProspective cohort study.PurposeTo assess whether additional implantation of Coflex following spinal decompression provided better clinical outcomes compared to decompression alone for symptomatic lumbar spinal stenosis (LSS) and to determine whether improvement in clinical outcomes correlated with changes in the radiological indices studied.Overview of LiteratureLiterature on benefits of additional Coflex implantation compared to decompression alone for symptomatic LSS is limited.MethodsPatients with symptomatic LSS who met the study criteria were offered spinal decompression with Coflex implantation. Those patients who accepted Coflex implantation were placed in the Coflex group (n=22); while those opting for decompression alone, were placed in the comparison group (n=24). Clinical outcomes were assessed preoperatively, six-months, one-year and two-years postoperatively, using the Oswestry disability index, 100 mm visual analogue scale (VAS)-back pain and VAS-leg pain, and short form-36 (SF-36). Radiological indices (disc height, foraminal height and sagittal angle) were assessed preoperatively, six months, one year, and two years postoperatively.ResultsBoth groups showed statistically significant (p<0.001) improvement in all the clinical outcome indicators at all points in time as compared to the preoperative status. However, improvement in the Coflex group was significantly greater (p<0.001) than the comparison group. Changes in the radiological indices did not correlate significantly with the improvement in clinical outcome indicators.ConclusionsAdditional Coflex implantation after spinal decompression in symptomatic LSS offers better clinical outcomes than decompression alone in the short-term. Changes in radiological indices do not correlate with the improvements in clinical outcomes after surgery for symptomatic LSS.

Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis?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].…”

Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization

“…Röder et al 19 noted significant benefit with coflex stabilization after decompression in a matched-pair cohort comparison study from the Swiss Spine Registry and the European Spine Tango database. Kumar et al 12 reported statistically significant improvement with open microsurgical decompression for spinal stenosis and statistically significant improvement when coflex ILS was added to the decompression. Furthermore, although not comparing the procedure with ILS, Budithi et al 2 demonstrated the importance of evaluating walking distance in patients with spinal stenosis undergoing decompression surgery.…”

Interspinous implants: are the new implants better than the last generation? A review

“…Patients undergoing ILS utilizing Coflex found greater clinical composite success (CCS), with no difference between adverse events compared to fusion patients, in a 48-month follow-up period. Another study found a significantly greater improvement in ODI score, as well as VAS back and leg pain scores, among Coflex patients compared to those receiving standard decompression alone [21]. Surgical complications among the Coflex group included one durotomy, while the decompression-only group experienced four durotomies and one surgical site infection.…”

“…Other studies have reported the maintenance of initially improved VAS up to 2 years [21, 27, 36•, 38] or even 3 years [13,23]. Of the latter studies, three are with next-generation products [23,27,38] and three correspond to last-generation [13,21,36•] IPDs. In the preparation of this manuscript, the authors could only find two RCTs in the literature comparing the success of pain reduction between next-vs. last-generation IPDs [23,33].…”