Back to resultsA Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Primary Purpose
Degenerative Lumbar Spondylolisthesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Lumbar Spondylolisthesis focused on measuring Degenerative Disc Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
autogenous bone graft with the addition of OP-1 Putty
autogenous bone graft alone
Outcomes
Primary Outcome Measures
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00679107
Brief Title
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Official Title
A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
December 2000 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Olympus Biotech Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spondylolisthesis
Keywords
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
autogenous bone graft with the addition of OP-1 Putty
Arm Title
2
Arm Type
Active Comparator
Arm Description
autogenous bone graft alone
Intervention Type
Device
Intervention Name(s)
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other Intervention Name(s)
Uninstrumented posterolateral fusion
Intervention Description
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Primary Outcome Measure Information:
Title
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
Time Frame
6 weeks; 3, 6, 9, 12, and 24 months
Secondary Outcome Measure Information:
Title
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).
Time Frame
6 weeks; 3, 6, 9, 12, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
New Haven
State/Province
Connecticut
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
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