Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02087267|
Recruitment Status : Recruiting
First Posted : March 14, 2014
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment|
|Degeneration of Lumbar Intervertebral Disc Degenerative Spondylolisthesis||Procedure: 1- or 2-level spinal fusion|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
1- or 2-level spinal fusion
Patients suffering from symptomatic degenerative disc disease or degenerative spondylolisthesis grade 1 or 2 with chronic low back pain, pain in the leg or buttock, muscle weakness, sensation abnormalities and/or neurogenic claudication requiring 1- or 2-level lumbar or lumbar-sacral spinal fusion.
Procedure: 1- or 2-level spinal fusion
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™
- Overall fusion rate [ Time Frame: 2 years postoperatively ]Outcome Measure by CT/MRI and clinical follow-up
- Rate of pedicle system implant failures [ Time Frame: 2 years postoperatively ]Outcome Measure by CT/MRI and clinical follow-up
- Rate of implant related, surgery related, postoperative and general complications [ Time Frame: 2 years postoperatively ]Outcome Measure by CT/MRI and clinical follow-up
- Rate of subsequent surgical interventions [ Time Frame: 2 years postoperatively ]Outcome Measure by CT/MRI and clinical follow-up
- Change of the mean total Oswestry Low Back Pain Disability Questionnaire (ODI) [ Time Frame: Change from the preoperative baseline to the 2 year postoperative assessment ]clinical follow-up
- Change of the mean Visual Analogue Scale (VAS) on low back pain [ Time Frame: Change from the preoperative baseline to the 2 year postoperative assessment ]clinical follow-up
- Change of the mean Visual Analogue Scale (VAS) on pain in the leg and buttock (experienced in the pain-dominant leg) [ Time Frame: Change from the preoperative baseline to the 2 year postoperative assessment ]clinical follow-up
- Visual Analogue Scale (VAS) on patient's satisfaction with the surgery [ Time Frame: 2 years postoperatively ]clinical follow-up
- Change of the mean disc height at index level [ Time Frame: Change from the preoperative baseline to the 2 year postoperative assessment ]Outcome Measure by CT/MRI and clinical follow-up
- Rate of symptomatic adjacent segment disease [ Time Frame: 2 years postoperatively ]Outcome Measure by CT/MRI and clinical follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087267
|Contact: Christoph Fleege, MD||+49 69 6705 1908||Christoph.Fleege@friedrichsheim.de|
|Universitätsklinikum SH Klinik für Neurochirurgie||Recruiting|
|Kiel, Schleswig-Holstein, Germany, 24105|
|Contact: Michael Synowitz, MD +49 431 500 ext 23600 Michael.Synowitz@uksh.de|
|Contact: Senol Jadik, MD +49 431 500 ext 23600 email@example.com|
|Klinikum Darmstadt, Klinik für Neurochirurgie||Active, not recruiting|
|Darmstadt, Germany, 64283|
|Orthopädische Universitätsklinik Friedrichsheim gGmbH||Recruiting|
|Frankfurt am Main, Germany, 60528|
|Contact: Michael Rauschmann, Prof., MD +49 69 6705-228 firstname.lastname@example.org|
|Principal Investigator: Michael Rauschmann, Prof., MD|
|Sub-Investigator: Christoph Fleege, MD|
|Städtisches Klinikum Görlitz gGmbH, Klinik für Neurochirurgie||Recruiting|
|Görlitz, Germany, 02828|
|Contact: Marcus Eif, MD +493581371560 email@example.com|
|Principal Investigator: Holger Schenke, MD|
|DIAKOVERE Annastift - Orthopädische Klinik der MHH||Recruiting|
|Hanover, Germany, 30625|
|Contact: Henning Windhagen, Prof. +49 511 5354 0 firstname.lastname@example.org|
|Contact: Dorothea Daentzer, Prof. +49 511 5354 0 email@example.com|
|Katholisches Klinikum, Brüderhaus Koblenz||Active, not recruiting|
|Koblenz, Germany, 56073|
|Kantonsspital St. Gallen Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates||Recruiting|
|St. Gallen, Switzerland, 9007|
|Contact: Thomas Forster, MD +41 71 494 13 96 firstname.lastname@example.org|
|Principal Investigator: Thomas Forster, MD|
|Sub-Investigator: Fabrice A Külling, MD|
|Principal Investigator:||Christoph Fleege, MD||Orthopädische Universitätsklinik Friedrichsheim|