OP-1 Putty for Posterolateral Fusions
June 9, 2011 updated by: Olympus Biotech Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
336
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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London, Ontario, Canada
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Toronto, Ontario, Canada
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California
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Santa Monica, California, United States
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Stanford, California, United States
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Colorado
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Denver, Colorado, United States
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Delaware
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Newark, Delaware, United States
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Florida
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Clearwater, Florida, United States
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Ft. Lauderdale, Florida, United States
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Miami, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Michigan
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Kalamazoo, Michigan, United States
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Southfield, Michigan, United States
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Missouri
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St. Louis, Missouri, United States
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New York
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New York, New York, United States
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Rochester, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Ohio
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Akron, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Tennessee
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Germantown, Tennessee, United States
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Texas
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San Antonio, Texas, United States
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Virginia
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
OP-1 Putty
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Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Other Names:
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Active Comparator: 2
Autograft
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Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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3, 6, 12, 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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3, 6, 12, 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
November 1, 2003
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
May 13, 2008
First Submitted That Met QC Criteria
May 13, 2008
First Posted (Estimate)
May 15, 2008
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S01-01US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.