Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

NCT ID: NCT00678353

Last Updated: 2011-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Degenerative Lumbar Spondylolisthesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Follow-up to S01-01US, conducted to expand information

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
2. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
3. The patient agrees to complete the necessary clinical and radiographic evaluations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus Biotech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Olympus Biotech

Locations

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Santa Monica, California, United States

Site Status

Stanford, California, United States

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Denver, Colorado, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Chicago, Illinois, United States

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Kalamazoo, Michigan, United States

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Southfield, Michigan, United States

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St Louis, Missouri, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Akron, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Germantown, Tennessee, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Countries

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United States Canada

Other Identifiers

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06-UPLF-01

Identifier Type: -

Identifier Source: org_study_id

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