Back to resultsOP-1 Putty for Posterolateral Fusions
Primary Purpose
Degenerative Lumbar Spondylolisthesis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spinal fusion
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Lumbar Spondylolisthesis focused on measuring Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
- The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
- The subject requires one level lumbar fusion (L-3 to S-1).
- The subject has a preoperative Oswestry Disability Index of 30-100.
Exclusion Criteria:
- The subject has active spinal and/or systemic infection.
- The subject is morbidly obese.
- The subject has a known sensitivity to any component of the OP-1 Putty.
- The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
- The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
OP-1 Putty
Autograft
Outcomes
Primary Outcome Measures
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
Secondary Outcome Measures
The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00677950
Brief Title
OP-1 Putty for Posterolateral Fusions
Official Title
OP-1 Putty for Posterolateral Fusions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Olympus Biotech Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
Detailed Description
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spondylolisthesis
Keywords
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
OP-1 Putty
Arm Title
2
Arm Type
Active Comparator
Arm Description
Autograft
Intervention Type
Procedure
Intervention Name(s)
Spinal fusion
Other Intervention Name(s)
Lumbar Spinal Fusion
Intervention Description
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Primary Outcome Measure Information:
Title
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
Time Frame
3, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
Time Frame
3, 6, 12, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
The subject requires one level lumbar fusion (L-3 to S-1).
The subject has a preoperative Oswestry Disability Index of 30-100.
Exclusion Criteria:
The subject has active spinal and/or systemic infection.
The subject is morbidly obese.
The subject has a known sensitivity to any component of the OP-1 Putty.
The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.
Facility Information:
City
Santa Monica
State/Province
California
Country
United States
City
Stanford
State/Province
California
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United States
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Denver
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Colorado
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United States
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Newark
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Delaware
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United States
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Clearwater
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United States
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Ft. Lauderdale
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Florida
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United States
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Miami
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Chicago
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Kalamazoo
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Southfield
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St. Louis
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Missouri
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New York
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New York
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Rochester
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United States
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Charlotte
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Akron
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Philadelphia
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United States
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Pittsburgh
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Pennsylvania
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United States
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Germantown
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Tennessee
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United States
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San Antonio
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United States
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Charlottesville
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Virginia
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United States
City
Fairfax
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Virginia
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United States
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
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OP-1 Putty for Posterolateral Fusions
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