Clinical experiences with a PEEK-based dynamic instrumentation device in lumbar spinal surgery: 2 years and no more

BackgroundDynamic spine implants were developed to prevent adjacent segment degeneration (ASD) and adjacent segment disease (ASDi). Purpose of this study was to investigate the clinical and radiological outcomes of “topping off” devices following lumbar spinal fusion procedure using a PEEK-based dynamic rod system. Moreover, this study focused on the hypothesis that “topping off” devices can prevent ASD.MethodsThis prospective nonrandomized study included patients with indication for single-level lumbar fusion and radiological signs of ASD without instability. The exclusion criteria were previous lumbar spine surgery and no sign of disc degeneration in the adjacent segment according to magnetic resonance imaging. All patients were treated with single-level lumbar interbody fusion and dynamic stabilization of the cranial adjacent segment. Patients underwent a clinical examination and radiographs preoperatively and at 1 and 2 years after surgery. Analyses were performed on clinical data collected with the German Spine Registry using the core outcome measure index (COMI) and visual analogue scale (VAS) scores for back and leg pain.ResultsA total of 22 patients (6 male and 16 female) with an average age of 57.6 years were included in the study; 20 patients completed the follow-up (FU). The average COMI score was 9.0 preoperatively, 4.2 at the 1-year FU, and 4.7 at the 2-year FU. The average preoperative VAS scores for back and leg pain were 7.7 and 7.1, respectively. At the 1-year FU, the scores were 4.25 for back pain and 2.2 for leg pain, and at the 2-year FU, the scores were 4.7 for back pain and 2.3 for leg pain. At FU, failure of the dynamic topping off implant material was verified in four cases, and ASD of the segment cranial to the topping off was confirmed in three cases.ConclusionsThese results demonstrate significant improvements in clinical outcomes and pain reduction after lumbar spinal fusion with topping off at 2 years after surgery. However, the implant failed due to the high rate of implant failure and the development of ASD in the segment cranial to the dynamic stabilized segment.

[1]  M. Maltenfort,et al.  Rate of Adjacent Segment Disease in Cervical Disc Arthroplasty Versus Single-Level Fusion: Meta-analysis of Prospective Studies , 2013, Spine.

[2]  C. Röder,et al.  Erratum to: Dynamic posterior stabilization for degenerative lumbar spine disease: a large consecutive case series with long-term follow-up by additional postal survey , 2016, European Spine Journal.

[3]  R. Colbrunn,et al.  Hybrid dynamic stabilization: a biomechanical assessment of adjacent and supraadjacent levels of the lumbar spine. , 2012, Journal of neurosurgery. Spine.

[4]  O. Schwarzenbach,et al.  The dynamic neutralization system for the spine: a multi-center study of a novel non-fusion system , 2002, European Spine Journal.

[5]  Deng-hui Xie,et al.  Adjacent segment degeneration after single-segment PLIF: the risk factor for degeneration and its impact on clinical outcomes , 2011, European Spine Journal.

[6]  C. Perka,et al.  Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion , 2010, European Spine Journal.

[7]  A. Diwan,et al.  Interpedicular kinematics in an in vitro biomechanical assessment of a bilateral lumbar spondylolytic defect. , 2014, Clinical biomechanics.

[8]  A. Mannion,et al.  Prize Winner : Long-Term Follow-up Suggests Spinal Fusion Is Associated With Increased Adjacent Segment Disc Degeneration But Without In fl uence on Clinical Outcome Results of a Combined Follow-up From 4 Randomized Controlled Trials , 2014 .

[9]  A. R.,et al.  Review of literature , 1969, American Potato Journal.

[10]  A. Nordwall,et al.  2001 Volvo Award Winner in Clinical Studies: Lumbar Fusion Versus Nonsurgical Treatment for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial From the Swedish Lumbar Spine Study Group , 2001, Spine.

[11]  J. Oppermann,et al.  Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial , 2014, BMC Musculoskeletal Disorders.

[12]  J. Katz,et al.  A Review of the 2001 Volvo Award Winner in Clinical Studies: Lumbar Fusion Versus Nonsurgical Treatment for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial From the Swedish Lumbar Spine Study Group , 2006, Spine.

[13]  Werner Schmoelz,et al.  Dynamic Stabilization of the Lumbar Spine and Its Effects on Adjacent Segments: An In Vitro Experiment , 2003 .

[14]  P. Gerszten,et al.  The use of a hybrid dynamic stabilization and fusion system in the lumbar spine: preliminary experience. , 2010, Neurosurgical focus.

[15]  Sang-Hun Lee,et al.  Clinical Outcomes of 3 Fusion Methods Through the Posterior Approach in the Lumbar Spine , 2006, Spine.

[16]  A. Alpízar-Aguirre,et al.  Posterior dynamic stabilization of the lumbar spine with the Accuflex rod system as a stand-alone device: experience in 20 patients with 2-year follow-up , 2010, European Spine Journal.

[17]  K.,et al.  Classification of posterior dynamic stabilization devices. , 2007, Neurosurgical focus.

[18]  R. Schmidt,et al.  Adjacent Segment Mobility After Rigid and Semirigid Instrumentation of the Lumbar Spine , 2009, Spine.

[19]  A. Prescher,et al.  Biomechanical testing of a PEEK‐based dynamic instrumentation device in a lumbar spine model , 2017, Clinical biomechanics.

[20]  Joseph S. Cheng,et al.  Immediate Biomechanical Effects of Lumbar Posterior Dynamic Stabilization Above a Circumferential Fusion , 2007, Spine.

[21]  C. Pfirrmann,et al.  Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration , 2001, Spine.

[22]  A. Rohlmann,et al.  Which Radiographic Parameters Are Linked to Failure of a Dynamic Spinal Implant? , 2012, Clinical orthopaedics and related research.

[23]  Paul Park,et al.  Adjacent Segment Disease after Lumbar or Lumbosacral Fusion: Review of the Literature , 2004, Spine.

[24]  C. Röder,et al.  Dynamic posterior stabilization for degenerative lumbar spine disease: a large consecutive case series with long-term follow-up by additional postal survey , 2016, European Spine Journal.

[25]  D. Weiner,et al.  Does Radiographic Osteoarthritis Correlate with Flexibility of the Lumbar Spine? , 1994, Journal of the American Geriatrics Society.

[26]  G. Bergmann,et al.  Comparison of the effects of bilateral posterior dynamic and rigid fixation devices on the loads in the lumbar spine: a finite element analysis , 2007, European Spine Journal.

[27]  E. Ferrero,et al.  Radiologic adjacent segment degeneration 2 years after lumbar fusion for degenerative spondylolisthesis. , 2016, Orthopaedics & traumatology, surgery & research : OTSR.

[28]  B. Jeanneret,et al.  Dynamic Stabilization in Addition to Decompression for Lumbar Spinal Stenosis with Degenerative Spondylolisthesis , 2006, Spine.

[29]  A. Mannion,et al.  Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials. , 2013, The spine journal : official journal of the North American Spine Society.

[30]  O. Schwarzenbach,et al.  Long-term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device , 2012, Clinical spine surgery.

[31]  C. Dickman,et al.  Cause of adjacent-segment disease after spinal fusion , 1999, The Lancet.

[32]  C. Perka,et al.  Dynamic stabilization adjacent to single-level fusion: Part II. No clinical benefit for asymptomatic, initially degenerated adjacent segments after 6 years follow-up , 2010, European Spine Journal.

[33]  M. Modic,et al.  Imaging of degenerative disk disease. , 1988, Radiology.

[34]  T. Sun,et al.  Comparison of the Dynesys Dynamic Stabilization System and Posterior Lumbar Interbody Fusion for Lumbar Degenerative Disease , 2016, PloS one.

[35]  F. Lolli,et al.  Does hybrid fixation prevent junctional disease after posterior fusion for degenerative lumbar disorders? A minimum 5-year follow-up study , 2015, European Spine Journal.