Other Clinical Trial - OP-1 Putty for Posterolateral Fusions

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Degenerative Lumbar Spondylolisthesis
Spondylolisthesis

Clinical Trial Details

NCT number	NCT00677950
Study type	Interventional
Source	Olympus Biotech Corporation
Contact
Status	Completed
Phase	N/A
Start date	October 2001
Completion date	November 2005

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06407063` - Long-term Reoperations After Lumbar Spinal Stenosis Surgery
Active, not recruiting	`NCT03469791` - Degenerative Spondylolisthesis; Micro-decompression vs Decompression + Instrumented Fusion; Long Term Follow up	N/A
Recruiting	`NCT05961956` - Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis	Phase 1/Phase 2
Completed	`NCT00678353` - Study of OP-1 Putty in Uninstrumented Posterolateral Fusions	N/A
Completed	`NCT00679107` - A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions	N/A
Recruiting	`NCT02290314` - Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion	N/A