Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Phase 2
Completed
- Conditions
- Degenerative Spinal StenosisDisk Herniation
- Interventions
- Device: Hyalospine
- Registration Number
- NCT00939406
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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 is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- 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 Criteria
- Contraindication to MRI
- Instrumented fusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyalospine Hyalospine Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
- Primary Outcome Measures
Name Time Method Rate of adverse events 6 months Extent of epidural fibrosis 12 months
- Secondary Outcome Measures
Name Time Method differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results 12 months
Trial Locations
- Locations (3)
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
🇩🇪Frankfurt, Germany
Klinik Sonnehof
🇨🇭Bern, Switzerland
Sint Maartenskliniek, Nijmegen, The Netherlands
🇳🇱Woerden, Netherlands