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

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ClinicalTrials.gov Identifier: NCT00939406
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and 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.

Condition or disease Intervention/treatment Phase
Degenerative Spinal Stenosis Disk Herniation Device: Hyalospine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Rate of adverse events [ Time Frame: 6 months ]
  2. Extent of epidural fibrosis [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

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

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