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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00679107

Enrollment

Registered

2008-05-16

Start date

1999-06-30

Completion date

2005-07-31

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lumbar Spondylolisthesis

Keywords

Degenerative Disc Disease

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.

Interventions

DEVICEUse of OP-1 Putty in Uninstrumented posterolateral fusion

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 81 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026