title: Herniectomy versus herniectomy with the DIAM spinal stabilization system in patients with sciatica and concomitant low back pain: results of a prospective randomized controlled multicenter trial.
abstract: To investigate the short and medium term efficacy and patient outcomes of DIAM spinal stabilization system on back pain, disability, leg pain and quality of life.
  
  
  
  165 patients were enrolled; 146 patients with a single level disc herniation (L2 to L5) were randomized: 75 investigational (herniectomy and DIAM) and 71 control (herniectomy alone) treated and followed up for 24 months.
  
  
  
  Significant improvements overtime (P < 0.001) in both groups but not significantly different between groups for visual analog scale (VAS) back pain at 6 months (investigational -3.97 ± 2.55 vs control-3.37 ± 3.15, P = 0.228) and Oswestry Disability Index (ODI) at 12 months (-38.55 ± 20.10 vs -37.19 ± 22.61, P = 0.719). For both outcomes, there was no statistically significant difference between the groups, at all postoperative time points. Although the enrolment ended before the intended sample size (308 patients) was reached, the number of patients reaching the VAS back pain minimally clinically important difference (MCID) of ≥2.2 at 6 months was higher in the investigational (79.4 % vs control 57.1 %, P = 0.008). These results were sustained throughout 24 months (82.8 vs 64.4 %, P < 0.05). In average, surgical duration (P < 0.001), blood loss (P = 0.029) and skin incision (P < 0.001) in the investigational were 10 min longer, 22.5 ml greater and 2.0 cm wider than control group (median values). Improved tertiary outcomes from BL to 24 mo in both groups (investigational vs control): VAS leg pain (mean decrease -6.41 ± 2.57 to -6.41 vs -5.61 ± to -3.30); improved quality of life (SF-36: 20.68 ± 9.44 vs 16.90 ± 10.74); pain medication reduction: 56.7 vs 47.9 %; return to work: 45.7 vs 38.0 %. Adverse event rates: 68.5 % investigational and 66.2 % control.
  
  
  
  This is the first randomized controlled trial to report equivalent efficacy and safety of herniectomy with or without DIAM spinal stabilizing device. Leg pain, back pain and the level of disability were not significantly different between groups; however, number of patients reaching the MCID for back pain was significantly higher in the investigational group at 6 through 24 months.
authors.affiliation: Spitalzentrum Oberwallis, Ueberlandstr. 14, CH 3900, Brig, Switzerland. Ferdinand.krappel@hopitalvs.ch.
authors.forename: Ferdinand
authors.identifier: http://orcid.org/0000-0001-6165-2289
authors.initials: F
authors.lastname: Krappel
authors.affiliation: I.R.C.C.S. Istituto Ortopedico Galeazzi, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Brayda-Bruno
authors.affiliation: AZ Sint-Elisabeth, Godveerdegemstraat 69, 9620, Zottegem, Belgium.|AZ Sint-Lucas, Groenebriel 1, 9000, Ghent, Belgium.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Alessi
authors.affiliation: Hôpital de la Citadelle, Service de Neurochirurgie, Boulevard du 12 ème de, Ligne, 1, 400, Liège, Belgium.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Remacle
authors.affiliation: Neurological Department, H. Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08 907, Barcelona, Spain.
authors.forename: Luis Alberto
authors.initials: LA
authors.lastname: Lopez
authors.affiliation: Hospital de León, Altos de Nava s/n, 24 071, León, Spain.
authors.forename: Jesus Javier
authors.initials: JJ
authors.lastname: Fernández
authors.affiliation: Department d'Orthopédie, Hôpital Cantonal Fribourg, 1708, Fribourg, Switzerland.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Maestretti
authors.affiliation: Radiologie, Universitätsklinik Balgrist, Forchstrasse 340, CH-8008, Zurich, Switzerland.
authors.forename: Christian W A
authors.initials: CWA
authors.lastname: Pfirrmann
mesh_terms: D000328:Adult; D001416:Back Pain / Q000209:etiology; D017586:Diskectomy / Q000379:methods*; D005260:Female; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000601:surgery*; D017116:Low Back Pain / Q000209:etiology; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000295:instrumentation / Q000379:methods*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012585:Sciatica / Q000209:etiology; D016896:Treatment Outcome
keywords: Herniectomy; Low back pain; Lumbar spine; Posterior dynamic stabilizing device; Randomized controlled trial, DIAM