Die Wirbelsäule 2019; 03(02): 101-106
DOI: 10.1055/a-0841-3848
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Anular Closure RCT – Interpretation der Ergebnisse und Bedeutung für die klinische Entscheidungsfindung im Jahr 2019

Anular Closure RCT – Interpretation of results and impact for clinical decision-making in 2019
Claudius Thomé
Universitätsklinik für Neurochirurgie, Medizinische Universität Innsbruck
› Author Affiliations
Further Information

Publication History

Publication Date:
17 April 2019 (online)

Zusammenfassung

Obwohl die lumbale Bandscheibenoperation als häufigster wirbelsäulenchirurgischer Eingriff mit sehr guten klinischen Ergebnissen in Verbindung gebracht wird, besteht ein relevantes Reherniations- und Reoperationsrisiko. Dies gilt insbesondere für Patienten mit hohen Bandscheiben und großen Anulusdefekten, also für bis zu 30 % des Gesamtkollektivs. Um die Rezidivraten nach Mikrodiskektomie zu senken, wurde ein Anulusverschlussimplantat (ACD) entwickelt und kürzlich in einem großen Multicenter-RCT evaluiert. Dieser Übersichtsartikel soll die publizierten Daten und deren Bedeutung für die wirbelsäulenchirurgische Praxis zusammenfassen.

In der Kontrollgruppe des RCT konnte die hohe Rezidivrate von ca. 25 % für diese Hochrisikopopulation nach limitierte Mikrodiskektomie bestätigt werden. Die Reherniationsrate wurde durch das Implantat um die Hälfte gesenkt, so dass bei einer Häufigkeit von Implantat-bedingten Revisionen von unter 3 % auch eine Halbierung der Reoperationsrate erzielt wurde. Die nach harten Kriterien definierte Erfolgsquote betrug ohne Implantat 66 % und mit ACD 76 %. Diese statistisch signifikanten Unterschiede in Reoperations- und Erfolgsraten führten nach 3 Jahren auch zu einem signifikanten Outcomevorteil. Auffällig waren häufige Endplattenveränderungen bei ACD-Patienten, die zwar ohne klinische Konsequenzen blieben, aber eine Langzeitbeobachtung anraten.

Bei der Hochrisikopopulation macht ein Anulusverschluss nach aktueller Datenlage Sinn und verbessert das Operationsergebnis, so dass der Patientenselektion entscheidender Stellenwert zukommt.

Abstract

Although lumbar microdiscectomy as the most common spinal procedure worldwide is considered a largely successful procedure, it carries a significant risk of reherniation, consecutive reoperation and unsatisfactory outcome. Patients with high discs and large anular defects have been identified to be particularly prone for recurrence. In an attempt to reduce rehernation rates an anular closure device has been developed and recently tested in a large multicenter RCT. This paper aims at reviewing the corresponding published data and its impact on spine surgery practice.

The control group in the RCT confirmed the high recurrence rate of 25 % after limited microdiscectomy in this high-risk subpopulation. The implant reduced reherniation and reoperation rates by half, as implant-associated revisions were rare (< 3 %). The strictly defined success rate amounted to 66 % vs. 76 % in favor of the ACD. These statistically significant differences resulted in a significant outcome difference after 3 years. Endplate lesions were very common in ACD patients, but not related to clinical outcome. This finding nevertheless warrants long-term follow-up.

In summary, anular closure improves outcome in the high-risk subpopulation and thus makes sense, but patient selection is crucial.

 
  • Literatur

  • 1 McGirt MJ, Eustacchio S, Varga P. et al. A prospective cohort study of close interval computed tomography and magnetic resonance imaging after primary lumbar discectomy: factors associated with recurrent disc herniation and disc height loss. Spine 2009; 34: 2044-2051
  • 2 Martin BI, Mirza SK, Flum DR. et al. Repeat surgery after lumbar decompression for herniated disc: the quality implications of hospital and surgeon variation. Spine J 2012; 12: 89-97
  • 3 Fritzell P, Knutsson B, Sanden B. et al. Recurrent Versus Primary Lumbar Disc Herniation Surgery: Patient-reported Outcomes in the Swedish Spine Register Swespine. Clin Orthop Relat Res 2015; 473: 1978-1984
  • 4 Watters 3rd WC, McGirt MJ. An evidence-based review of the literature on the consequences of conservative versus aggressive discectomy for the treatment of primary disc herniation with radiculopathy. Spine J 2009; 9: 240-257
  • 5 Thomé C, Barth M, Scharf J. et al. Outcome after lumbar sequestrectomy compared with microdiscectomy: a prospective randomized study. J Neurosurg Spine 2005; 2: 271-278
  • 6 Carragee EJ, Han MY, Suen PW. et al. Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence. J Bone Joint Surg Am 2003; 85-A: 102-108
  • 7 Miller LE, McGirt MJ, Garfin SR. et al. Association of annular defect width after lumbar discectomy with risk of symptom recurrence and reoperation – Systematic review and Meta-analysis of comparative studies. Spine 2018; 43: E308-E315
  • 8 Bailey A, Araghi A, Blumenthal S. et al. Prospective, multicenter, randomized, controlled study of anular repair in lumbar discectomy: two-year follow-up. Spine 2013; 38: 1161-1169
  • 9 Wilke HJ, Ressel L, Heuer F. et al. Can prevention of reherniation be investigated? Establishment of a herniation model and experiments with an anular closure device. Spine 2013; 38: E587-E593
  • 10 Martens F, Lesage G, Muir JM. et al. Implantation of a bone-anchored annular closure device in conjunction with tubular minimally invasive discectomy for lumbar disc herniation: a retrospective study. BMC Musculoskelet Disord 2018; 19: 269
  • 11 Belykh E, Krutko AV, Baykov ES. et al. Preoperative estimation of disc herniation recurrence after microdiscectomy: predictive value of a multivariate model based on radiographic parameters. Spine J 2017; 17: 390-400
  • 12 Thome C, Klassen PD, Bouma GJ. et al. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J 2018; 18: 2278-2287
  • 13 Kienzler JC, Klassen PD, Miller LE. et al. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high-risk for reherniation. Spine 2019 (under review).
  • 14 Barth M, Fontana J, Thome C. et al. Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device. J Clin Neurosci 2016; 34: 288-293
  • 15 Kuršumović A, Kienzler JC, Bouma GJ. et al. Morphology and clinical relevance of vertebral endplate changes following limited lumbar discectomy with or without bone-anchored annular closure. Spine 2018; 43: 1386-1394
  • 16 Kuršumović A, Rath SA. Performance of an Annular Closure Device in a „Real-World“, Heterogeneous, At-Risk, Lumbar Discectomy Population. Cureus 2017; 9: e1824
  • 17 Kuršumović A, Rath SA. Effectiveness of an annular closure device in a „real-world“ population: stratification of registry data using screening criteria from a randomized controlled trial. Med Devices (Auckl) 2018; 11: 193-200
  • 18 Martens F, Vajkoczy P, Jadik S. et al. Patients at the highest risk for reherniation following lumbar discectomy in a multicenter randomized controlled trial. JB JS Open Access 2018; 3: e0037