Prospective randomized trial regarding the use of PEEK-Rods for stabilization in lumbar circumferential fusion

Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus Rudolf Elle gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena0 sites100 target enrollmentAugust 17, 2015

ConditionsM53.26 M42.16 M53.27 M42.17

Overview

Phase: N/A
Intervention: Not specified
Conditions: M53.26
Sponsor: Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus Rudolf Elle gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena
Enrollment: 100
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 17, 2015

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Klinik für Orthopädie einschl. Unfallchirurgie am Waldkrankenhaus Rudolf Elle gGmbH incl. Lehrstuhl für Orthopädie der Friedrich-Schiller-Universität Jena

Eligibility 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

•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.