Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine (NCT02068729) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
Stopped: The study was terminated early due to slow enrollment and difficulties with long-term follow-up
131 participantsStarted 2014-06
Plain-language summary
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1
* Inadequate response to conservative medical care over a period of at least 6 months
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
* Skeletally mature and ≥ 18 years of age at the time of enrollment
Exclusion Criteria:
* Previous anterior/posterior/lateral spine surgery at the index level
* Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine
* Active systemic infection or infection at the operative site
* Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
* Metabolic bone disease such as osteoporosis that contradicts spinal surgery
* History of an osteoporotic fracture
* History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
* Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
* Known allergy to titanium, cobalt chrome or PEEK
* Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
* Current medical condition (e.g., unstable cardiac disease, c…