Status:
COMPLETED
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Degenerative Spinal Stenosis
Disk Herniation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
- Subjects who have failed conservative care for at least 6 weeks.
Exclusion
- Contraindication to MRI
- Instrumented fusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00939406
Start Date
November 1 2009
End Date
November 1 2012
Last Update
December 20 2012
Active Locations (3)
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1
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
Frankfurt, Germany, 60389
2
Sint Maartenskliniek, Nijmegen, The Netherlands
Woerden, Netherlands
3
Klinik Sonnehof
Bern, Canton of Bern, Switzerland, 3006