Clinical Trials Directory

Trials / Completed

CompletedNCT00679107

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

A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Olympus Biotech Corporation · Industry
Sex
All
Age
18 Years – 81 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Conditions

Interventions

TypeNameDescription
DEVICEUse of OP-1 Putty in Uninstrumented posterolateral fusionUse of OP-1 Putty in Uninstrumented posterolateral fusion

Timeline

Start date
1999-06-01
Primary completion
2000-12-01
Completion
2005-07-01
First posted
2008-05-16
Last updated
2011-06-10

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00679107. Inclusion in this directory is not an endorsement.