NCT00677950

OP-1 Putty for Posterolateral Fusions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Olympus Biotech Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.

Conditions

• Degenerative Lumbar Spondylolisthesis

Interventions

Type	Name	Description
PROCEDURE	Spinal fusion	Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis

Timeline

• Start date: 2001-10-01
• Primary completion: 2003-11-01
• Completion: 2005-11-01
• First posted: 2008-05-15
• Last updated: 2011-06-10

Locations

24 sites across 2 countries: United States, Canada