A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
1 other identifier
interventional
48
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 1999
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 13, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedJune 10, 2011
June 1, 2011
1.5 years
May 13, 2008
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
6 weeks; 3, 6, 9, 12, and 24 months
Secondary Outcomes (1)
Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).
6 weeks; 3, 6, 9, 12, and 24 months
Study Arms (2)
1
EXPERIMENTALautogenous bone graft with the addition of OP-1 Putty
2
ACTIVE COMPARATORautogenous bone graft alone
Interventions
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2008
First Posted
May 16, 2008
Study Start
June 1, 1999
Primary Completion
December 1, 2000
Study Completion
July 1, 2005
Last Updated
June 10, 2011
Record last verified: 2011-06