PMID- 27704286
OWN - NLM
STAT- MEDLINE
DCOM- 20171221
LR  - 20181202
IS  - 1432-0932 (Electronic)
IS  - 0940-6719 (Linking)
VI  - 26
IP  - 3
DP  - 2017 Mar
TI  - 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.
PG  - 865-876
LID - 10.1007/s00586-016-4796-6 [doi]
AB  - PURPOSE: 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. METHODS: 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. RESULTS: 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. 
      CONCLUSIONS: 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.
FAU - Krappel, Ferdinand
AU  - Krappel F
AUID- ORCID: 0000-0001-6165-2289
AD  - Spitalzentrum Oberwallis, Ueberlandstr. 14, CH 3900, Brig, Switzerland. 
      Ferdinand.krappel@hopitalvs.ch.
FAU - Brayda-Bruno, Marco
AU  - Brayda-Bruno M
AD  - I.R.C.C.S. Istituto Ortopedico Galeazzi, Milan, Italy.
FAU - Alessi, Giovanni
AU  - Alessi G
AD  - AZ Sint-Elisabeth, Godveerdegemstraat 69, 9620, Zottegem, Belgium.
AD  - AZ Sint-Lucas, Groenebriel 1, 9000, Ghent, Belgium.
FAU - Remacle, Jean-Michel
AU  - Remacle JM
AD  - Hopital de la Citadelle, Service de Neurochirurgie, Boulevard du 12 eme de, 
      Ligne, 1, 400, Liege, Belgium.
FAU - Lopez, Luis Alberto
AU  - Lopez LA
AD  - Neurological Department, H. Bellvitge, Feixa Llarga s/n, L'Hospitalet de 
      Llobregat, 08 907, Barcelona, Spain.
FAU - Fernandez, Jesus Javier
AU  - Fernandez JJ
AD  - Hospital de Leon, Altos de Nava s/n, 24 071, Leon, Spain.
FAU - Maestretti, Gianluca
AU  - Maestretti G
AD  - Department d'Orthopedie, Hopital Cantonal Fribourg, 1708, Fribourg, Switzerland.
FAU - Pfirrmann, Christian W A
AU  - Pfirrmann CWA
AD  - Radiologie, Universitatsklinik Balgrist, Forchstrasse 340, CH-8008, Zurich, 
      Switzerland.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161004
PL  - Germany
TA  - Eur Spine J
JT  - European spine journal : official publication of the European Spine Society, the 
      European Spinal Deformity Society, and the European Section of the Cervical Spine 
      Research Society
JID - 9301980
SB  - IM
MH  - Adult
MH  - Back Pain/etiology
MH  - Diskectomy/*methods
MH  - Female
MH  - Humans
MH  - Intervertebral Disc Displacement/complications/*surgery
MH  - Low Back Pain/etiology
MH  - Lumbar Vertebrae/*surgery
MH  - Male
MH  - Middle Aged
MH  - Orthopedic Procedures/instrumentation/*methods
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Quality of Life
MH  - Sciatica/etiology
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Herniectomy
OT  - Low back pain
OT  - Lumbar spine
OT  - Posterior dynamic stabilizing device
OT  - Randomized controlled trial, DIAM
EDAT- 2016/10/06 06:00
MHDA- 2017/12/22 06:00
CRDT- 2016/10/06 06:00
PHST- 2016/04/15 00:00 [received]
PHST- 2016/09/22 00:00 [accepted]
PHST- 2016/08/19 00:00 [revised]
PHST- 2016/10/06 06:00 [pubmed]
PHST- 2017/12/22 06:00 [medline]
PHST- 2016/10/06 06:00 [entrez]
AID - 10.1007/s00586-016-4796-6 [pii]
AID - 10.1007/s00586-016-4796-6 [doi]
PST - ppublish
SO  - Eur Spine J. 2017 Mar;26(3):865-876. doi: 10.1007/s00586-016-4796-6. Epub 2016 
      Oct 4.