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

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spondylolisthesis
• Interventions: Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion

• Registration Number: NCT00679107
• Lead Sponsor: Olympus Biotech Corporation

Brief 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.

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2000-12
• Study Completion: 2005-07
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. 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.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. 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.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Use of OP-1 Putty in Uninstrumented posterolateral fusion	autogenous bone graft with the addition of OP-1 Putty
2	Use of OP-1 Putty in Uninstrumented posterolateral fusion	autogenous bone graft alone

Primary Outcome Measures

Name	Time	Method
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).	6 weeks; 3, 6, 9, 12, and 24 months

Secondary Outcome Measures

Name	Time	Method
Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).	6 weeks; 3, 6, 9, 12, and 24 months