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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939406
First Posted: July 15, 2009
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Extent of epidural fibrosis [ Time Frame: 12 months ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00939406     History of Changes
Other Study ID Numbers: Hyalospine
First Submitted: July 14, 2009
First Posted: July 15, 2009
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases