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

Primary Purpose

Degenerative Spinal Stenosis, Disk Herniation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hyalospine
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spinal Stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
  • Sint Maartenskliniek, Nijmegen, The Netherlands
  • Klinik Sonnehof

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Hyalospine

Arm Description

Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone

Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.

Outcomes

Primary Outcome Measures

Rate of adverse events
Extent of epidural fibrosis

Secondary Outcome Measures

differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results

Full Information

First Posted
July 14, 2009
Last Updated
December 19, 2012
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT00939406
Brief Title
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Acronym
Hyalospine
Official Title
A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spinal Stenosis, Disk Herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone
Arm Title
Hyalospine
Arm Type
Experimental
Arm Description
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
Intervention Type
Device
Intervention Name(s)
Hyalospine
Intervention Description
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
Primary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
6 months
Title
Extent of epidural fibrosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pavlov, MD
Organizational Affiliation
Sint Maartenskliniek, Nijmegen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Sint Maartenskliniek, Nijmegen, The Netherlands
City
Woerden
Country
Netherlands
Facility Name
Klinik Sonnehof
City
Bern
ZIP/Postal Code
3006
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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