Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Degenerative Lumbar Spondylolisthesis Clinical Trial

Official title:
Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Status Completed

Clinical Trial Summary

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

Clinical Trial Description

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Degenerative Lumbar Spondylolisthesis
Spondylolisthesis

Clinical Trial Details

NCT number	NCT00678353
Study type	Observational
Source	Olympus Biotech Corporation
Contact
Status	Completed
Phase	N/A
Start date	May 2007
Completion date	August 2007

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
Completed	`NCT00677950` - OP-1 Putty for Posterolateral Fusions	N/A
Recruiting	`NCT05961956` - Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis	Phase 1/Phase 2
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