Vergleich dorsaler Dekompression nicht stabilisiert und dynamisch stabilisiert mit LimiFlex™

Zusammenfassung

Hintergrund: Lumbale Spinalkanalstenosen werden häufig mittels dorsaler Dekompression behandelt. Die Abtragung posteriorer Strukturen führt jedoch zu einer Erhöhung der biomechanischen Instabilität und kann weitere Komplikationen hervorrufen. Durch eine Fusion kann dies reduziert werden. Jedoch können weitere Komplikationen, wie z. B. eine stark reduzierte Flexibilität oder Anschlussdegeneration, auftreten. Um diese Problematik zu umgehen, wurden dynamische Stabilisierungssysteme wie das paraspinale Spannband LimiFlex (PSB) entwickelt. Diese prospektive Studie vergleicht das klinische Ergebnis von Patienten mit implantiertem PSB und Patienten ohne PSB. Patienten und Methoden: Es wurden 63 Patienten mit 1- oder 2-etagiger lumbaler Spinalkanalstenose dorsal dekomprimiert. 40 Patienten erhielten nach der Dekompression das PSB. Es wurden Rücken-, Hüft- und Knieschmerzen sowie die funktionelle Einschränkung der Patienten prä- und postoperativ nach 3, 6 und 12 Monaten aufgenommen. Die Schmerzen wurden mittels der visuellen Analogskala (VAS) und die funktionale Beeinträchtigung mittels des Oswestry Disability Index (ODI) erhoben. Alle auftretenden Adverse Events wurden dokumentiert. Ergebnisse: Patienten, die das PSB erhielten, zeigten eine bessere Schmerzreduktion und eine deutlichere Verbesserung der funktionalen Beeinträchtigung als Patienten ohne PSB. Der VAS- und ODI-Verlauf der beiden Behandlungsgruppen unterschied sich signifikant bei 2 betroffenen Etagen. Schlussfolgerung: Die dynamische Stabilisierung mit dem PSB nach dorsaler Dekompression führte zu besseren Ergebnissen hinsichtlich der VAS- und ODI-Verbesserung als alleinige dorsale Dekompression. Der größte Nutzen des PBS zeigte sich bei 2 betroffenen Etagen.

Abstract

Background: Lumbar spinal canal stenosis is commonly treated by dorsal decompression. However, resection of posterior elements increases the biomechanical instability and may lead to further complications. In order to prevent this, fusion of the involved segments is often performed. But further complications may be associated with this, for example, highly reduced flexibility. In order to overcome fusion-related problems, dynamic stabilisation devices, like the new LimiFlex™ Paraspinous Tension Band (PSB), have been developed. This prospective study compares dorsal decompression without stabilisation and dorsal decompression with stabilisation using the PSB in patients with lumbar canal stenosis. Methods: Sixty-three patients with stenosis involving one or two lumbar vertebral levels were treated with dorsal decompression. Forty received the PSB following decompression surgery. Back, hip and leg pain as well as patientʼs degree of disability were assessed preoperatively and at 3, 6 and 12 months postoperatively for all patients. Evaluations were conducted using the visual analogue scale (VAS) and the Oswestry disability index (ODI). Adverse events during the study period were evaluated. Results: Patients who received the PSB experienced a better pain relief and improvement in disability compared to patients who received treatment through decompression only. A significant difference of VAS and ODI development was found between both groups when treating two vertebral levels. Furthermore, the total number of adverse events was lower in the PSB group compared to the decompression group. Conclusion: Dynamic stabilisation using the PSB delivers better results in terms of VAS and ODI values when compared to only dorsal decompression. In addition, it is also associated with a lower number of complications. The PSB is most favourable when 2 levels are treated.

Schlüsselwörter

LimiFlex - Stenose - dorsale Dekompression - dynamische Stabilisierung - Rückenschmerz

Key words

LimiFlex - stenosis - dorsal decompression - dynamic stabilisation - back pain

• Literatur

• 1 Ewerbeck V, Wentzensen A, Holz F, Krämer KL, Pfeil J, Sabo D Hrsg. Standardverfahren in der operativen Orthopädie und Unfallchirurgie. 3. Aufl.. Stuttgart: Thieme; 2007
• 2 Fielding LC, Alamin TF, Voronov LI et al. Parametric and Cadaveric Models of Lumbar Flexion Instability and Flexion Restricting Implant. Proceedings of the 58th Annual Meeting of the Orthopaedic Research Society. 2012
• 3 Fielding LC, Alamin TF, Voronov LI et al. Flexion-Restricting Stabilization System Restores Kinematics after Simulated Injury. 17th International Meeting on Advanced Spine Techniques. 2010
• 4 Kocak T, Cakir B, Reichel G et al. Screw loosening after posterior dynamic stabilization – review of literature. Acta Chir Orthop Traumatol Cech 2010; 77: 134-139
• 5 Lutz JA, Otten P, Maestretti G. Late infections after dynamic stabilization of the lumbar spine with Dynesis. Eur Spine J 2012; 21: 2573-2579
• 6 Wu ZX, Gong FT, Liu L et al. A comparative study on screw loosening in osteoporotic lumbar spine fusion between expandable and conventional pedicle screws. Arch Orthop Trauma Surg 2012; 132: 471-476
• 7 Klöckler C. Long-term results of the Dynesys implant. Orthopade 2010; 39: 559-564
• 8 Coe JD, Kitchel SH, Meisel HJ et al. NFlex Dynamic Stabilization System: Two-Year Clinical Outcomes of Multi-Center Study. J Korean Neurosurg Soc 2012; 51: 343-349
• 9 Jouve JL, de Gauzy JS, Blondel B et al. Use of the Universal Clamp for deformity and as an adjunct to fusion: preliminary results of scoliosis. J Child Orthop 2010; 4: 73-80
• 10 Bhadra A, Raman A, Tucker S et al. Interspinous implant in lumbar spinal stenosis: a prospective cohort. Eur J Orthop Surg Traumatol 2008; 18: 489-493
• 11 Holinka J, Krepler P, Matzner M et al. Stabilising effect of dynamic interspinous spacers in degenerative low-grade lumbar instability. Int Orthop 2011; 35: 395-400
• 12 Jia YH, Sun PF. Preliminary evaluation of posterior dynamic lumbar stabilization in lumbar degenerative disease in Chinese patients. Chin Med J (Engl) 2012; 125: 253-256
• 13 Lee SH, Lee JH, Hong SW et al. Spinopelvic alignment after interspinous soft stabilization with a tension band system in grade 1 degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976) 2010; 35: E691-E701
• 14 Anjarwalla NK, Brown LC, McGregor AH. The outcome of spinal decompression surgery 5 years on. Eur Spine J 2007; 16: 1842-1847
• 15 Weinstein JN, Tosteson TD, Lurie JD et al. Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine (Phila Pa 1976) 2010; 35: 1329-1338
• 16 Slätis P, Malmiyaara A, Heliövaara M et al. Long-term results of surgery for lumbar spinal stenosis: a randomised controlled trial. Eur Spine J 2011; 20: 1174-1181
• 17 Herkowitz HN, Kurz LT. Degenerative Lumbar Spondylolisthesis with Spinal Stenosis. J Bone Joint Surg Am 1991; 73: 802-808
• 18 Jang JW, Park JH, Hyun SJ et al. Clinical Outcomes and Radiologic Changes Following Microsurgical Bilateral Decompression via Unilateral Approach in Patients with Lumbar Canal Stenosis and Grade I Degenerative Spondylolisthesis with a Minimum 3-year Follow-up. J Spinal Disord Tech 2012; [Epub ahead of print]
• 19 Atlas SJ, Keller YA, Wu YA et al. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the main lumbar spine study. Spine (Phila Pa 1976) 2005; 30: 936-943
• 20 Yuan HA, Garfin SR, Dickman CA et al. A historical cohort study of pedicle screw fixation in thoracic, lumbar, and sacral spinal fusions. Spine (Phila Pa 1976) 1994; 19 (Suppl. 20) S2279-S2296
• 21 Park P, Garton HJ, Gala VC et al. Adjacent segment disease after lumbar or lumbosacral fusion: review of the literature. Spine (Phila Pa 1976) 2004; 29: 1938-1944
• 22 Deyo RA, Mirza SK, Martin BI et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010; 303: 1259-1265
• 23 Richter A, Schütz C, Hauck M et al. Does an interspinous device (Cofex™) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. Eur Spine J 2010; 19: 283-289
• 24 Ozkan N, Sandalcioglu IE, Petr O et al. Minimally invasive transpedicular dorsal stabilization of the thoracolumbar and lumbar spine using the minimal access non-traumatic insertion system (MANTIS): preliminary clinical results in 52 patients. J Neurol Surg A Cent Eur Neurosurg 2012; 73: 369-376
• 25 Trouillier H, Birkenmaier C, Rauch A et al. Posterior body fusion (PLIF) with cages and local bone graft in the treatment of spinal stenosis. Acta Orthop Belg 2006; 72: 460-466
• 26 Ghogawala Z, Benzel EC, Amin-Hanjani S et al. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine 2004; 1: 267-272
• 27 Sigmundsson FG, Jönsson B, Strömqvist B. Outcome of decompression with and without fusion in spinal stenosis with degenerative spondylolisthesis in relation to preoperative pain pattern: a register study of 1,624 patients. Spine J 2015; 15: 638-646
• 28 Kong DS, Kim ES, Eoh W. One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci 2007; 22: 330-335
• 29 Son S, Kim WK, Lee AG et al. A comparison of the clinical outcomes of decompression alone and fusion in elderly patients with two-level or more lumbar spinal stenosis. J Korean Neurosurg Soc 2013; 53: 19-25