Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Low Back Pain, Spondylolisthesis, Spinal Stenosis
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Spine, Lumbar spine, Spinal fusion, Low back pain, Fusion cage, Posterior lumbar interbody fusion, Bioresorbable, Peek
Eligibility Criteria
Inclusion Criteria: Both genders, age between 18 and 70 years Chronic low back pain (> 3 months) with or without leg pain but no signs of motor loss Based on clinical history, physical examination, and radiographic signs, pain interpreted as emanating from L4-L5 or L5-S1 Symptoms refractory to conservative treatment for at least 3 months Evidence of degenerative changes at L4-L5 or L5-S1 (spondylosis) on plain radiographs and/or CT scan, and/or MRI. The pathology should be predominant on one level. Single-level Posterior Lumbar Interbody Fusion surgery (PLIF) is indicated by the spine surgeon Additional posterior fixation is mandatory Use of autograft of the iliac crest is possible Ability to provide informed consent Exclusion Criteria: Previous lumbar spinal fusion All other previous spinal surgery except for successful removal of a herniated disc more than 2 years before entering the study Symptomatic degenerative disc disorder at more than one lumbar level Pregnancy or intention to become pregnant during the two year study Ongoing psychiatric illness Evidence of alcohol and/or drug abuse Inability to complete the questionnaires Inability to walk independently Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, old fracture, inflammatory process, or neoplasm Obvious painful and disabling arthritic hip joints
Sites / Locations
- BG Unfallklinik Halle, Klinik für Neurochirurgie
- Universität Rostock, Neurochirurgie
- VU University Medical Center
- Leids Universitair Medisch Centrum