Status:
COMPLETED
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Lead Sponsor:
Olympus Biotech Corporation
Conditions:
Degenerative Lumbar Spondylolisthesis
Eligibility:
All Genders
18-81 years
Phase:
NA
Brief Summary
This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
Detailed Description
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is i...
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 :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00679107
Start Date
June 1 1999
End Date
July 1 2005
Last Update
June 10 2011
Active Locations (5)
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1
New Haven, Connecticut, United States
2
Chicago, Illinois, United States
3
Royal Oak, Michigan, United States
4
Akron, Ohio, United States