M53.26 M42.16 M53.27 M42.17
Conditions
Interventions
Group 1: Group PEEK:
Use of PEEK(Polyetheretherketon)-rods for transpedicular stabilization in single-level transforaminal lumbar interbody fusions (TLIF)
Group 2: Group TITANIUM:
Use of titanium-rod
Sponsors
Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients with persistent lumbar, lumbosacral and/or non-radicular / radicular complaints, after failed conservative treatment of a period of at least 6 months will be included in the study. At the same time, in MRI a single-level lumbar osteochonditis Modic Type = 1 based on an idiopathic intervertebral disc degeneration Pfirrmann = III and/or a facet joint degeneration Grade 3 or 4 according to Fujiwara has to be present. Additional spinal or neuroforaminal stenoses as well as nucleus prolapses at the index segment do not represent contraindications. Degenerative spondylolistheses of the index segment up to Meyerding I as well as previous sequestrektomies or selective inter laminar decompression surgeries at the index segment do also not lead to exclusion. Every patient has to sign an agreement form with study
Exclusion criteria
Exclusion criteria: Patients with symptomatic segment degeneration of more than 1 lumbar segment as well as patients who had undergone spinal surgeries different from the described under inclusion criteria will be excluded from the study. Further exclusion criteria are spondylolistheses > Meyerding I or lumbar scoliosis Cobb-angle =10°. Patients with chronic nikotine-, alcohol- or drug abusus, a known allergy against (parts of) the implants, a „Body-Mass-Index“ (BMI) >30 kg/m2, as well as pregnant patients will be excluded from the study. Additionally, clinical, blood parameters or radiological signs of a renal- and liver disease, malignant tumours, chronic medication with corticoids or bone density increasing antiosteoporotic substances, presence of a chronic pain / somatization disorder (> Stadium I according to Gerbershagen), epilepsy or further diseases or reasons leading to recurrent falls lead to exclusion. Beside this, patients with the need for screw augmentation with bone cement as well as patients with the need of surgical revision due to screw misplacement or lateral screw misplacement > grade 2 (according to Mirza) in postoperative CT weill be excluded because of its negative influence on the grade of stability of the segment fixation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of successful fusion; CT and X-Ray (6 months after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression of degeneration of the cranial adjacent 2 segments; X-ray (6 month after surgery) and MRI (24 months after surgery) 2. Clinical Outcome (Pain: VAS for back-, leg-, and overall pain as well as its frequency - preoperatively, 1 week, 6 weeks, 6, 12, and 24 months postoperatively; Function: Oswestry Disability Index - preoperatively, 6 weeks, 6, 12, and 24 months postoperatively; Quality of life: SF-36 - preoperatively, 6 weeks, 6, 12, and 24 months postoperatively) 3. Age dependency of the criteria fusion success and adjacent segment degeneration 4. Bone density dependency of the criteria fusion success and adjacent segment degeneration | — |
Countries
Germany
Contacts
Public ContactTimo Zippelius
Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus "Rudolf Elle" gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
Outcome results
None listed