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

This study has been completed.
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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 July 28, 2014