A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Completed · Not applicable

Conditions studied: Degenerative Lumbar Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT00679107

Run by

Olympus Biotech Corporation

People needed

48

Starts

1999-06-01

Expected to finish

2005-07-01

Last updated by the study team

2011-06-10

Who can join

Age: 18 and older, up to 81. 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 — New Haven, Connecticut, United States
• Study site — Chicago, Illinois, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Akron, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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