Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00679328
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Tibial Nonunions
Device: Surgical implantation of OP-1 device or autograft bone graft material

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

Resource links provided by NLM:


Further study details as provided by Olympus Biotech Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Medical events, treatment related events, laboratory tests, medication use. [ Time Frame: 3, 6, 9, 12, 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: February 1992
Study Completion Date: December 1999
Primary Completion Date: August 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679328

Locations
United States, Arizona
Mesa, Arizona, United States
United States, California
Modesto, California, United States
San Diego, California, United States
Stanford, California, United States
United States, Colorado
Denver, Colorado, United States
Fort Carson, Colorado, United States
United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Texas
Galveston, Texas, United States
Lubbock, Texas, United States
Sponsors and Collaborators
Olympus Biotech Corporation
  More Information

No publications provided

Responsible Party: Shinichi Torii, Olympus Biotech
ClinicalTrials.gov Identifier: NCT00679328     History of Changes
Other Study ID Numbers: 91-01, TR-0056
Study First Received: May 13, 2008
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014