Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™
Condition: Degeneration of Lumbar Intervertebral Disc; Degenerative Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Observational

Summary: 
      The objective of the PMCF is to collect outcome information on patients suffering from
      symptomatic degenerative disc disease or degenerative spondylolisthesis requiring 1- or
      2-level lumbar or lumbar-sacral spinal fusion with posterior instrumentation and therefore
      receiving the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage
      ETurn™.
    

Detailed description: 
      Background: At present, metal pedicle screw systems made from titanium or stainless steel are
      commonly used for posterior stabilization. One disadvantage of theses metal devices is that
      they cause shadows and artifacts on CTs and MRIs which may hamper the postoperative
      exploration of the onset of spinal diseases and in particular the evaluation of the
      neuroforamina, the spinal canal and bone-implant interfaces. Therefore new concepts of
      pedicle screw devices use non-radiopaque materials such as carbon fiber-reinforced
      polyetheretherketone (CF/PEEK) without compromising mechanical properties compared to
      standard titanium implants and possibly reducing the risk for adjacent segment diseases.

      Description of the study devices:

      The icotec Pedicle System is intended to provide immobilization and stabilization of spinal
      segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and
      chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The carbon
      fiber-reinforced polyetheretherketone (CF/PEEK) that is used to produce the icotec pedicle
      system rod and screw shaft is a thermoplastic composite biomaterial exhibiting properties
      suitable for load-bearing orthopedic implants. The CF/PEEK material does not cause artifacts
      or shadows on adjacent tissues with all imaging modalities such as x-ray, CT, and MRI.
      Radiopaque markers or fibres made from titanium or tantalum are embedded. The pedicle system
      rod and screws allow this advantage to be realized without compromising mechanical properties
      compared to standard titanium implants.

      Description of the study device - icotec CF/PEEK TLIF Cage ETurn: The icotec ETurn™ TLIF cage
      consists of a windowed body with a central slot, a distraction/ insertion wedge and surface
      treads on its cranial and caudal surfaces that serve to guide and anchor the implant (see
      figure 4). The concentrically arranged treads enable the implant to turn on its own from its
      position of insertion into the disc space to its transverse end position. The tread surfaces
      help to create a significantly larger pressure-bearing contact surface between the implant
      and the bone than the conventional pointed anchoring elements.

      Risk Analysis and risk Management: Most of the risks of implant related, surgical and
      postoperative complications associated with the implantation of the icotec CF/PEEK Pedicle
      System in combination with the icotec ETurn™ TLIF cage, are comparable to the risks
      associated with other TLIF surgeries with cages and pedicle screw systems intended for lumbar
      spine stabilization.

      risks and possible adverse outcomes have been identified for the icotec CF/PEEK Pedicle
      System as well as for the CF/PEEK TLIF Cage ETurn.

      Legal Aspects: For this post-market investigation only CE-marked medical devices will be used
      within their intended purpose and no additional invasive or other stressful examinations are
      to be carried out.

      All subjects will voluntarily sign the Informed Consent document. Ethics approval for the
      study will be obtained prior to starting the study

      Data Monitoring: Independent on-site Monitoring will be performed at all investigational
      sites.
    

Intervention name(s): 1- or 2-level spinal fusion
Intervention type(s): Procedure
Intervention description(s): 1- or 2-level lumbar or lumbar-sacral spinal fusion with the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage ETurn™
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic of selected spine centers