OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

June 9, 2011 updated by: Olympus Biotech Corporation

Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.

Study Type

Interventional

Enrollment (Actual)

122

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
    • Arizona
      • Mesa, Arizona, United States
    • California
      • Modesto, California, United States
      • San Diego, California, United States
      • Stanford, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Fort Carson, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Michigan
      • Detroit, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New York
      • New York, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Texas
      • Galveston, Texas, United States
      • Lubbock, Texas, 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

Description

Inclusion Criteria:

  1. Patients must show radiographic skeletal maturity
  2. Documented evidence of previous fracture management
  3. Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
  4. Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment

Exclusion Criteria:

  1. Patients who do not have adequate vascularity to permit healing
  2. Patients with inadequate skin coverage
  3. Patients with chronic use of steroidal medications
  4. Patients with active infection systemically or at the site of nonunion.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Surgical implantation of OP-1
Device: Surgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
Active Comparator: 2
Surgical implantation of bone graft material
Device: Surgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
Time Frame: 3, 6, 9, 12, 24 months
3, 6, 9, 12, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical events, treatment related events, laboratory tests, medication use.
Time Frame: 3, 6, 9, 12, 24 months
3, 6, 9, 12, 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

February 1, 1992

Primary Completion (Actual)

August 1, 1996

Study Completion (Actual)

December 1, 1999

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

Other Study ID Numbers

  • 91-01
  • TR-0056

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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