Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
1 other identifier
observational
202
2 countries
22
Brief Summary
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
Shorter than P25 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 13, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedJune 10, 2011
June 1, 2011
May 13, 2008
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of bone by CT scan
3+ years post-treatment from the Pivotal study S01-01US
Secondary Outcomes (1)
Re-assessments of all clinical parameters from S01-01US
3+ years post-treatment from the Pivotal study S01-01US
Study Arms (1)
1
Follow-up to S01-01US, conducted to expand information
Eligibility Criteria
Patients treated in clinical protocol S01-01US
You may qualify if:
- The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
- The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
- The patient agrees to complete the necessary clinical and radiographic evaluations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Southfield, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Fairfax, Virginia, United States
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2008
First Posted
May 15, 2008
Study Start
May 1, 2007
Study Completion
August 1, 2007
Last Updated
June 10, 2011
Record last verified: 2011-06