title: Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study.
abstract: BACKGROUND
  Surgical decompression for lumbar spinal stenosis (LSS) has been associated with poorer outcomes in patients with pronounced low back pain (LBP) as compared to patients with predominant leg pain. This cross registry study assessed potential benefits of the interlaminar coflex® device as an add-on to bony decompression alone.
  
  
  METHODS
  Patients with lumbar decompression plus coflex® (SWISSspine registry) were compared with decompressed controls (Spine Tango registry). Inclusion criteria were LSS and a preoperative back pain level of ≥5 points. 1:1 propensity score-based matching was performed. Outcome measures were back and leg pain relief, COMI score improvement, patient satisfaction, complication, and revision rates.
  
  
  RESULTS
  50 matched pairs without residual significant differences but age were created. At the 7-9 months follow-up interval the coflex® group had higher back (p=0.014) and leg pain relief (p<0.001) and COMI score improvement (p=0.029) than the decompression group. Patient satisfaction was 90% in both groups. No revision was documented in the coflex® and one in the decompression group (2.0%).
  
  
  CONCLUSIONS
  In the short-term, lumbar decompression with coflex® compared with decompression alone in patients with LSS and pronounced LBP at baseline is a safe and effective treatment option that appears beneficial regarding clinical and functional outcomes. However, residual confounding of non-measured covariables may have partially influenced our findings. Also, despite careful inclusion and exclusion of cases the cross registry approach introduces a potential for selection bias that we could not totally control for and that makes additional studies necessary.
authors.affiliation: Institute for Evaluative Research in Medicine, University of Bern, Stauffacherstrasse 78, 3012, Bern, Switzerland. christoph.roeder@memcenter.unibe.ch.
authors.forename: C
authors.initials: C
authors.lastname: Röder
authors.affiliation: Department of Orthopedic Surgery, Luzerner Kantonsspital, Spitalstrasse 16, 6000, Lucerne, Switzerland.
authors.forename: B
authors.initials: B
authors.lastname: Baumgärtner
authors.affiliation: The Spine Center, Bahnhofstrasse 3, 3600, Thun, Switzerland.
authors.forename: U
authors.initials: U
authors.lastname: Berlemann
authors.affiliation: Institute for Evaluative Research in Medicine, University of Bern, Stauffacherstrasse 78, 3012, Bern, Switzerland.
authors.forename: E
authors.initials: E
authors.lastname: Aghayev
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000453:epidemiology / Q000601:surgery*; D016022:Case-Control Studies; D019299:Decompression, Surgical / Q000009:adverse effects* / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications; D013130:Spinal Stenosis / Q000453:epidemiology / Q000601:surgery*
keywords: Back pain; Decompression; Dynamic stabilization; Interlaminar spacer; Lumbar spinal stenosis