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

June 9, 2011 updated by: Olympus Biotech Corporation

A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • Ohio
      • Akron, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, 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 81 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
autogenous bone graft with the addition of OP-1 Putty
Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other Names:
  • Uninstrumented posterolateral fusion
ACTIVE_COMPARATOR: 2
autogenous bone graft alone
Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other Names:
  • Uninstrumented posterolateral fusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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).
Time Frame: 6 weeks; 3, 6, 9, 12, and 24 months
6 weeks; 3, 6, 9, 12, and 24 months

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

June 1, 1999

Primary Completion (ACTUAL)

December 1, 2000

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

May 13, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (ESTIMATE)

May 16, 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

  • S99-01US

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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