Degenerative Spinal Stenosis, Disk Herniation
Conditions
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.
Interventions
DEVICEHyalospine
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse events | 6 months |
| Extent of epidural fibrosis | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results | 12 months |
Countries
Germany, Netherlands, Switzerland
Outcome results
None listed