Lumbar Spinal Stenosis clinical trials at University of California Health
4 in progress, 1 open to eligible people
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
open to eligible people ages 18 years and up
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.
at UC Davis UC Irvine UCLA UCSD UCSF
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis with Spinal Stenosis
Sorry, in progress, not accepting new patients
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
at UC Davis UCSF
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Sorry, in progress, not accepting new patients
The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. >80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.
at UCSF
Targeted Nutritional Supplement After Lumbar Spine Surgery: A Randomized, Placebo-Controlled, Double-Blind Trial
Sorry, not yet accepting patients
The goal of this clinical trial is to prospectively evaluate the effects of essential amino acid (EAA) supplementation on the volume and structure of the muscles surrounding the spine (paraspinal musculature). The main questions it aims to answer are: - Does EAA supplementation preserve paraspinal muscle volume (PMV) and influence changes to spinal alignment following lumbar spine surgery? - Does preserving paraspinal muscle volume (PMV) improve post-operative functional status? - Does preserving PMV reduce post-operative complications, pain, and opioid consumption? Participants will be asked to: - Consume either EAA supplement or placebo (alanine) twice daily for one week before and two weeks after lumbar spine surgery - Record pain levels and medication use in a diary - Perform functional assessments at routine follow-up visits after surgery - Undergo blood draws to monitor nutrition status and health - Undergo one spine magnetic resonance imaging (MRI) before surgery as part of routine surgical planning - Undergo one additional spine MRI after surgery to monitor PMV after treatment Researchers will compare the group that consumed EAA supplement and the group that consumed placebo to see if there is a difference in paraspinal muscle volume changes and measures of spinal alignment, functional abilities, pain levels, and opioid use.
at UC Irvine
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