Status:
COMPLETED
OP-1 Putty for Posterolateral Fusions
Lead Sponsor:
Olympus Biotech Corporation
Conditions:
Degenerative Lumbar Spondylolisthesis
Eligibility:
All Genders
18-85 years
Phase:
NA
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 spondyloli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00677950
Start Date
October 1 2001
End Date
November 1 2005
Last Update
June 10 2011
Active Locations (24)
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1
Santa Monica, California, United States
2
Stanford, California, United States
3
Denver, Colorado, United States
4
Newark, Delaware, United States