Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
This study has been completed.
Sponsor:
AO Clinical Investigation and Documentation
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00939406
First received: July 14, 2009
Last updated: December 19, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Degenerative Spinal Stenosis Disk Herniation |
Device: Hyalospine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- Rate of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Extent of epidural fibrosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | November 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone
|
|
|
Experimental: Hyalospine
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
|
Device: Hyalospine
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939406
Locations
| Germany | |
| Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main | |
| Frankfurt, Germany, 60389 | |
| Netherlands | |
| Sint Maartenskliniek, Nijmegen, The Netherlands | |
| Woerden, Netherlands | |
| Switzerland | |
| Klinik Sonnehof | |
| Bern, Switzerland, 3006 | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
| Principal Investigator: | Paul Pavlov, MD | Sint Maartenskliniek, Nijmegen, The Netherlands |
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT00939406 History of Changes |
| Other Study ID Numbers: | Hyalospine |
| Study First Received: | July 14, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Swissmedic Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Netherlands: Medical Ethics Review Committee (METC) Netherlands:Health care inspectorate |
Additional relevant MeSH terms:
|
Hernia Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013