Ferdinand Krappel1, Marco Brayda-Bruno2, Giovanni Alessi3,4, Jean-Michel Remacle5, Luis Alberto Lopez6, Jesus Javier Fernández7, Gianluca Maestretti8, Christian W A Pfirrmann9. 1. Spitalzentrum Oberwallis, Ueberlandstr. 14, CH 3900, Brig, Switzerland. Ferdinand.krappel@hopitalvs.ch. 2. I.R.C.C.S. Istituto Ortopedico Galeazzi, Milan, Italy. 3. AZ Sint-Elisabeth, Godveerdegemstraat 69, 9620, Zottegem, Belgium. 4. AZ Sint-Lucas, Groenebriel 1, 9000, Ghent, Belgium. 5. Hôpital de la Citadelle, Service de Neurochirurgie, Boulevard du 12 ème de, Ligne, 1, 400, Liège, Belgium. 6. Neurological Department, H. Bellvitge, Feixa Llarga s/n, L'Hospitalet de Llobregat, 08 907, Barcelona, Spain. 7. Hospital de León, Altos de Nava s/n, 24 071, León, Spain. 8. Department d'Orthopédie, Hôpital Cantonal Fribourg, 1708, Fribourg, Switzerland. 9. Radiologie, Universitätsklinik Balgrist, Forchstrasse 340, CH-8008, Zurich, Switzerland.
Abstract
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.
RCT Entities:
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.
Authors: James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna N A Tosteson; Brett Hanscom; Jonathan S Skinner; William A Abdu; Alan S Hilibrand; Scott D Boden; Richard A Deyo Journal: JAMA Date: 2006-11-22 Impact factor: 56.272
Authors: Scott L Parker; Stephen K Mendenhall; Saniya S Godil; Priya Sivasubramanian; Kevin Cahill; John Ziewacz; Matthew J McGirt Journal: Clin Orthop Relat Res Date: 2015-06 Impact factor: 4.176
Authors: Frank M Phillips; Leonard I Voronov; Ioannis N Gaitanis; Gerard Carandang; Robert M Havey; Avinash G Patwardhan Journal: Spine J Date: 2006 Nov-Dec Impact factor: 4.166
Authors: Brian J Neuman; Kevin Y Wang; Andrew B Harris; Micheal Raad; Richard A Hostin; Themisctocles S Protopsaltis; Christopher P Ames; Peter G Passias; Munish C Gupta; Eric O Klineberg; Robert Hart; Shay Bess; Khaled M Kebaish Journal: Spine Deform Date: 2022-10-11