Degeneration of Lumbar Intervertebral DiscNCT02087267
Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™
An observational study of Degeneration of Lumbar Intervertebral Disc and Degenerative Spondylolisthesis, run by Sitona AG at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc, Degenerative Spondylolisthesis
- What is being tested?
- 1- or 2-level spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2014to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic of selected spine centers
Who may be able to join
- 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
- Unsuccessful adequate conservative treatment
- 1- or 2- contiguous level lumbar spinal fusion between L2 and S1 with posterior instrumentation in combination with Transforaminal Lumbar Interbody Fusion (TLIF)
- Age between 18 - 80 years at the time of surgery
- Skeletally mature patient
- Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and imaging evaluations and the prescribed rehabilitation
- Patient signed Informed Consent
Who cannot join
- No adequate non-operative care prior to being treated with a lumbar fusion device
- 3-level fusion or more
- Fusion not between L2 and S1
- Previous lumbar spinal surgery, other than discectomy at the level(s) to be operated on
- Spondylolisthesis acc. to Meyerding grade 3 or higher
- Transforaminal access to the disc space is obstructed
Show all 33Show fewer
- Use of bone grafts other than autologous grafts, demineralized bone matrix without additional growth factors and synthetic bone substitute without additional growth factors. Growth factor enhanced grafts, cement or any other graft material are excluded.
- Adiposity, severe obesity (BMI > 35 kg/m2)
- Any contraindication for MRI scan including heart pacemaker, metallic foreign body (metal sliver) in the eye or brain, aneurysm clip in the brain, severe claustrophobia etc.
- Discitis, spondylodiscitis
- Acute or chronic infection, previous surgical site infection or severe defect of the osseous structures
- Open wounds
- Patient who takes immunosuppressive or long-term steroid use
- Fever
- Allergy or intolerance to any device material (e.g. Carbon/PEEK, titanium or tantalum)
- Foreign body sensitivity
- Insufficient form fit between the implant and the bone owing to deformation or destruction of the pedicles or of the vertebral body end plates
- Risk that the intervertebral device can subside into the vertebral bodies
- Bone tumors in the region of the implant anchoring
- Severe osteoporosis or similar bone density loss, incl. any metabolic bone disease
- Cases, in which the progression of degenerative disease is so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance
- Systemic or metabolic illnesses (i.e. insulin-dependent diabetes)
- Patient who is suffering from rheumatological or other inflammatory joint disease
- Paralysis of lower extremity
- Generally poor condition of the patient
- Psychosocial issues; lack of co-operation by the patient
- Drug abuse or alcoholism
- Any medical or surgical condition that could preclude the potential success of the implantation
- Any condition not described in the indications for use
- Unwillingness or inability of the patient to follow the instructions for postoperative treatment or with the follow-up evaluation schedule
- Female patient who is pregnant or plans to become pregnant during the course of the study
- Prisoner
- Patient who has not signed the Informed Consent
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
Orthopädische Universitätsklinik Friedrichsheim gGmbH
Frankfurt am Main, 60528
Städtisches Klinikum Görlitz gGmbH, Klinik für Neurochirurgie
Görlitz, 02828
DIAKOVERE Annastift - Orthopädische Klinik der MHH
Hanover, 30625
Universitätsklinikum SH Klinik für Neurochirurgie
Kiel, Schleswig-Holstein, 24105
Katholisches Klinikum, Brüderhaus Koblenz
Koblenz, 56073
Switzerland1 site
Kantonsspital St. Gallen Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
Sankt Gallen, 9007
About this study
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™.
Read the 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.
- Being tested
- 1- or 2-level spinal fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- or 2-level spinal fusionProcedure or surgery
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™
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 1- or 2-level spinal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall fusion rate
Outcome Measure by CT/MRI and clinical follow-up
Measured: 2 years postoperatively
Secondary outcomes (9)
Rate of pedicle system implant failures
Outcome Measure by CT/MRI and clinical follow-up
Measured: 2 years postoperatively
Rate of implant related, surgery related, postoperative and general complications
Outcome Measure by CT/MRI and clinical follow-up
Measured: 2 years postoperatively
Rate of subsequent surgical interventions
Outcome Measure by CT/MRI and clinical follow-up
Measured: 2 years postoperatively
Change of the mean total Oswestry Low Back Pain Disability Questionnaire (ODI)
clinical follow-up
Measured: Change from the preoperative baseline to the 2 year postoperative assessment
Change of the mean Visual Analogue Scale (VAS) on low back pain
clinical follow-up
Measured: Change from the preoperative baseline to the 2 year postoperative assessment
Change of the mean Visual Analogue Scale (VAS) on pain in the leg and buttock (experienced in the pain-dominant leg)
clinical follow-up
Measured: Change from the preoperative baseline to the 2 year postoperative assessment
Visual Analogue Scale (VAS) on patient's satisfaction with the surgery
clinical follow-up
Measured: 2 years postoperatively
Change of the mean disc height at index level
Outcome Measure by CT/MRI and clinical follow-up
Measured: Change from the preoperative baseline to the 2 year postoperative assessment
Rate of symptomatic adjacent segment disease
Outcome Measure by CT/MRI and clinical follow-up
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sitona AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Eif, MD, Principal investigator, Städtisches Klinikum Görlitz gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087267
- Sponsor's protocol ID
- SITONA_01/2014
- Status last verified
- Dec 2022
- First submitted
- 12 Mar 2014
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: will be decided in due time
Publications
Eif M, Forster T, Fleege C, Kilian F, Schmitt AD, Daentzer D. Lumbar fusion using a carbon-fiber PEEK pedicle screw system combined with a carbon-fiber PEEK TLIF cage: a prospective, multicenter study. BMC Musculoskelet Disord. 2025 Mar 6;26(1):224. doi: 10.1186/s12891-025-08457-7.
PubMed 40050812
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™
- ClinicalTrials.gov ID
- NCT02087267
- Acronym / sponsor ID
- SITONA_01/2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Sitona AGUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1- or 2-level spinal fusion | – | Procedure: 1- or 2-level spinal fusionPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic of selected spine centers
Key inclusion criteria (7 listed)
- 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
- Unsuccessful adequate conservative treatment
- 1- or 2- contiguous level lumbar spinal fusion between L2 and S1 with posterior instrumentation in combination with Transforaminal Lumbar Interbody Fusion (TLIF)
- Age between 18 - 80 years at the time of surgery
- Skeletally mature patient
Key exclusion criteria (33 listed)
- No adequate non-operative care prior to being treated with a lumbar fusion device
- 3-level fusion or more
- Fusion not between L2 and S1
- Previous lumbar spinal surgery, other than discectomy at the level(s) to be operated on
- Spondylolisthesis acc. to Meyerding grade 3 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1- or 2-level spinal fusion1- 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™ | Procedure or surgery | 1- or 2-level spinal fusion |
Primary outcome
Overall fusion rate
Time frame: 2 years postoperatively
Outcome Measure by CT/MRI and clinical follow-up
9 secondary outcomes
Rate of pedicle system implant failures
Time frame: 2 years postoperatively
Rate of implant related, surgery related, postoperative and general complications
Time frame: 2 years postoperatively
Rate of subsequent surgical interventions
Time frame: 2 years postoperatively
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
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
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
Visual Analogue Scale (VAS) on patient's satisfaction with the surgery
Time frame: 2 years postoperatively
Change of the mean disc height at index level
Time frame: Change from the preoperative baseline to the 2 year postoperative assessment
Rate of symptomatic adjacent segment disease
Time frame: 2 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 40050812Eif M, Forster T, Fleege C, Kilian F, Schmitt AD, Daentzer D. Lumbar fusion using a carbon-fiber PEEK pedicle screw system combined with a carbon-fiber PEEK TLIF cage: a prospective, multicenter study. BMC Musculoskelet Disord. 2025 Mar 6;26(1):224. doi: 10.1186/s12891-025-08457-7.
- Individual participant dataSharing planned: Undecided. will be decided in due time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Eif, MD principal investigator
Städtisches Klinikum Görlitz gGmbH
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration of Lumbar Intervertebral Disc and Degenerative Spondylolisthesis, run by Sitona AG at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall fusion rate (time frame: 2 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.