Lumbar Fusion With The Icotec CF/PEEK Pedicle System In Combination With The Icotec CF/PEEK TLIF Cage ETurn™

NCT02087267 | Completed

• 1 other identifier: SITONA_01/2014
• Study Type: observational
• Target: 94
• Locations: 2 countries
• Sites: 6

Brief 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™.

Conditions

Degeneration of Lumbar Intervertebral Disc; Degenerative Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Overall fusion rate

  Outcome Measure by CT/MRI and clinical follow-up

  2 years postoperatively

Secondary Outcomes (9)

• Rate of pedicle system implant failures

  2 years postoperatively

• Rate of implant related, surgery related, postoperative and general complications

  2 years postoperatively

• Rate of subsequent surgical interventions

  2 years postoperatively

• Change of the mean total Oswestry Low Back Pain Disability Questionnaire (ODI)

  Change from the preoperative baseline to the 2 year postoperative assessment

• Change of the mean Visual Analogue Scale (VAS) on low back pain

  Change from the preoperative baseline to the 2 year postoperative assessment

Study Arms (1)

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

Interventions

1- or 2-level spinal fusion PROCEDURE

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™

1- or 2-level spinal fusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic of selected spine centers

You may qualify if:

• 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
• 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

You may not qualify if:

• No adequate non-operative care prior to being treated with a lumbar fusion device
• 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
• 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)

Sponsors & Collaborators

• Sitona AG: lead

Study Sites (6)

Universitätsklinikum SH Klinik für Neurochirurgie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Orthopädische Universitätsklinik Friedrichsheim gGmbH

Frankfurt am Main, 60528, Germany

Location

Städtisches Klinikum Görlitz gGmbH, Klinik für Neurochirurgie

Görlitz, 02828, Germany

Location

DIAKOVERE Annastift - Orthopädische Klinik der MHH

Hanover, 30625, Germany

Location

Katholisches Klinikum, Brüderhaus Koblenz

Koblenz, 56073, Germany

Location

Kantonsspital St. Gallen Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40050812 DERIVED

Study Officials

• Marcus Eif, MD

  Städtisches Klinikum Görlitz gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

CH (1); DE (5)