OP-1 Putty for Posterolateral Fusions

Completed · Not applicable

Conditions studied: Degenerative Lumbar Spondylolisthesis

In brief

The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.

Key facts

Study ID

NCT00677950

Run by

Olympus Biotech Corporation

People needed

336

Starts

2001-10-01

Expected to finish

2005-11-01

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 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.

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 — Newark, Delaware, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, 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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