Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Completed

Conditions studied: Degenerative Lumbar Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT00678353

Run by

Olympus Biotech Corporation

People needed

202

Starts

2007-05-01

Expected to finish

2007-08-01

Last updated by the study team

2011-06-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

You may not qualify if…

• There are no exclusion criteria for participation in this protocol.

Where it is running

• Study site — Santa Monica, California, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Fairfax, Virginia, United States
• Study site — Halifax, Nova Scotia, Canada
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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