Clinical Trial to Evaluate Safety and Efficacy of HyalospineÂ® in Lumbar Laminectomy or Laminotomy
The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Degenerative Spinal Stenosis
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
AO Clinical Investigation and Documentation
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00939406
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
Narrowing of the spinal canal.
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
A degenerative spinal disease that can involve any part of the VERTEBRA, the INTERVERTEBRAL DISK, and the surrounding soft tissue.
The ratio of maximum blood flow to the MYOCARDIUM with CORONARY STENOSIS present, to the maximum equivalent blood flow without stenosis. The measurement is commonly used to verify borderline stenosis of CORONARY ARTERIES.
Outgrowth of immature bony processes or bone spurs (OSTEOPHYTE) from the VERTEBRAE, reflecting the presence of degenerative disease and calcification. It commonly occurs in cervical and lumbar SPONDYLOSIS.