Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

June 9, 2011 updated by: Olympus Biotech Corporation

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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 Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • United States
    • California
      • Santa Monica, California, United States
      • Stanford, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Ft. Lauderdale, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Kalamazoo, Michigan, United States
      • Southfield, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Fairfax, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated in clinical protocol S01-01US

Description

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.

Exclusion Criteria:

1. There are no exclusion criteria for participation in this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Follow-up to S01-01US, conducted to expand information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of bone by CT scan
Time Frame: 3+ years post-treatment from the Pivotal study S01-01US
3+ years post-treatment from the Pivotal study S01-01US

Secondary Outcome Measures

Outcome Measure
Time Frame
Re-assessments of all clinical parameters from S01-01US
Time Frame: 3+ years post-treatment from the Pivotal study S01-01US
3+ years post-treatment from the Pivotal study S01-01US

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Biotech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 13, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-UPLF-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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