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Sponsored by: |
Stryker Biotech |
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Information provided by: | Stryker Biotech |
ClinicalTrials.gov Identifier: | NCT00677950 |
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.
Condition | Intervention |
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Degenerative Lumbar Spondylolisthesis |
Procedure: Spinal fusion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | OP-1 Putty for Posterolateral Fusions |
Enrollment: | 336 |
Study Start Date: | October 2001 |
Study Completion Date: | November 2005 |
Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OP-1 Putty
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Procedure: Spinal fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
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2: Active Comparator
Autograft
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Procedure: Spinal fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Monique Duncan | Stryker Biotech |
Responsible Party: | Stryker Biotech ( Monique Duncan ) |
Study ID Numbers: | S01-01US |
Study First Received: | May 13, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00677950 |
Health Authority: | United States: Food and Drug Administration |
Degenerative Disc Disease |
Spinal Diseases Musculoskeletal Diseases Spondylolisthesis Bone Diseases |