Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy — Hyalospine  

Degenerative Spinal Stenosis Clinical Trial

Official title: A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Status Completed

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

• Degenerative Spinal Stenosis
• Disk Herniation
• Spinal Stenosis

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