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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00939406
Study type Interventional
Source AO Clinical Investigation and Documentation
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2009
Completion date November 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05549596 - CETIS-I (CEra Traction Improves Spine-I) N/A